High-Cadence Cycling for Parkinson Disease: A Single-Arm Hybrid Implementation and Effectiveness Clinical Trial in the Community Setting

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The Pedaling for Parkinson’s ™ (PFP) program is an existing community-based cycling intervention for individuals with PD. Although the program design was informed by efficacy studies, the implementation and effectiveness of the program have not been studied. We used a hybrid trial, which blends the study of implementation and effectiveness, to study the implementation of PFP in community gyms in the greater Boston area. METHODS This was a single-arm open-label pragmatic hybrid type 3 clinical trial designed to test implementation and observe clinical effectiveness. The implementation strategy consisted of enhanced multi-modal training and support for community-based gyms to implement the PFP protocol. Individuals with Hoehn and Yahr stage I-III idiopathic PD were recruited to participate. Primary implementation outcomes included adoption, gym fidelity, participant adherence, implementation cost, sustainability, acceptability, and safety. Secondary effectiveness outcomes included disease and quality of life measures. RESULTS 34 gyms were invited to participate. 4 gyms agreed to participate and implemented the PFP protocol. 24 individuals with idiopathic PD agreed to participate in the study and started classes. The program was implemented safely and sustainably across all sites but with high fidelity at only one of four gyms. 58% of individuals who started classes completed at least 80% of classes. 96% of participants who started classes enjoyed the program and 87% wished to continue. No effectiveness outcomes demonstrated a significant change from pre to post. CONCLUSION Our implementation strategy of additional multi-modal training and support in starting a PFP class was insufficient to achieve wide adoption of and high fidelity and adherence to the PFP protocol. However, participating gyms’ modifications of the PFP protocol in this study suggests such protocol modification may be necessary for effective implementation in the community setting. Future studies should first establish effectiveness of a revised PFP protocol. Implementation could then be achieved through a participatory approach in which barriers to gym participation are identified and mitigated early in the implementation process. Neurology Parkinson Disease Exercise Cadence Cycling Implementation Effectiveness Hybrid Type 3 Figures Figure 1 Figure 2 Figure 3 Figure 4 Contributions To The Literature Exercise therapy for Parkinson Disease (PD) improves motor symptoms and may be disease-modifying. Numerous studies have demonstrated the efficacy of exercise, but few have examined implementation and effectiveness in the community. This trial examined the impact of a multi-modal strategy to enhance implementation of a community-based cycling program for PD, and observed effectiveness of the intervention. Despite the enhanced implementation strategy, very few gyms agreed to implement the program, gym fidelity to the protocol was poor, and effectiveness was not observed. Insights gained from participating gyms’ modification to the protocol suggest changes to the protocol that could improve effectiveness. Further research is needed to better identify barriers to implementation. Background Parkinson Disease (PD) is a common neurodegenerative disorder. Progressive rigidity, tremor, slowness, and falls, along with myriad non-motor symptoms rob patients of quality of life. 1 Pharmacologic therapy can mitigate symptoms but has not been shown to protect the brain from further damage and degeneration. 2 , 3 Non-pharmacologic therapy—in particular exercise—can also improve symptoms. There is speculation that exercise may even slow disease progression and protect neurons. 4 – 6 While many exercises such as dance, 7 tai-chi, 8 , 9 running, 6 boxing, 10 – 12 Nordic walking, 13 , 14 qigong, 15 and aquatic exercise 16 , 17 have demonstrated efficacy in small clinical trials, few studies 11 have examined the implementation and effectiveness of these interventions in the real-world setting. Lack of evidence regarding feasibility and effectiveness of exercise may be one barrier to its routine prescription for individuals with PD. Hybrid trials blending implementation and effectiveness research may shorten the time gap between research discovery and routine uptake. Based on the framework proposed by Curran et al. in their 2012 paper 18 detailing methods for blending clinical effectiveness and implementation research, we designed a type 3 hybrid trial to test implementation and observe effectiveness of the Pedaling for Parkinson’s™ (PFP) program 19 —a community-based high-cadence cycling intervention. We chose to study the PFP cycling program for two reasons. First, cycling may be especially beneficial because it is often inexplicably but remarkably preserved in individuals with advanced PD who would never be able to run or complete many of the other exercise interventions available. 20 , 21 Second, PFP was designed based on the results of several clinical trials examining forced high cadence cycling (FHCC), which have been found to be effective at improving Parkinson’s symptoms. While PFP does not utilize FHCC as part of its program, the PFP protocol employs (non-forced) high cadence cycling (HCC). However, this methodology has never been studied in a clinical trial. Multiple small controlled trials have demonstrated that FHCC can ameliorate motor symptoms in individuals with PD as measured by the Unified Parkinson’s Disease Rating Scale-Part III and Timed up and Go. 22 – 31 In FHCC, individuals with PD pedal with either a tandem co-rider or a motor providing external augmentation at a cadence of 80–90 revolutions per minute (rpm)—which is faster than most individuals would pedal on their own. Although the rate is augmented, cycling on either device is an active, not passive, activity. In comparing FHCC versus cycling at a self-selected cadence on a stationary indoor bicycle, most of the published literature has found that, despite similar cardiovascular exertion in the two modes, improved motor symptoms are only observed in the forced-cadence modality. 26,29−31 One recent study did demonstrate gains in both forced and voluntary groups, but it was noted that the voluntary group self-selected to pedal at a cadence near the target achieved by the forced group. 25 Despite the noted benefit of FHCC, the tandem or motor-augmented bicycle equipment required to implement this protocol in the community is not readily available or affordable. Based on his research of FHCC at The Cleveland Clinic, Jay Alberts, PhD along with Cathy Frazier, a person with Parkinson’s, launched The Pedaling for Parkinson’s™ (PFP) program, 19 as an accessible and affordable alternative to FHCC. In PFP, individuals with PD are verbally coached to achieve moderate-exertion, high-cadence cycling (HCC) on solo-rider “spin” bikes. This differs from FHCC because there is no physical augmentation, only auditory and social cues encouraging participants to pedal at a high rate. Although anecdotal evidence suggests participants in existing PFP programs enjoy the classes, dissemination of the intervention remains limited and the effectiveness of the program has not been established. Even though written instructions on how to run the PFP program are available, informal discussion with gyms that had already implemented a Parkinson’s cycling program revealed they had sought out additional instruction in starting their program. This additional support was obtained either directly from the volunteer coordinator running PFP, from a class participant who had taken part in a PFP elsewhere, or from a for-profit company not affiliated with PFP that charged a fee to support setting up a PD cycling program. Based on this information, we hypothesized that community gyms might be more willing to implement the program with additional support that would empower them to realize that they could implement the program without specialized knowledge of Parkinson’s Disease and within their existing infrastructure. We therefore developed an implementation strategy of enhanced multi-modal training coupled with ongoing local support to supplement the existing written PFP start-up materials. We designed a type 3 hybrid trial to test our implementation strategy while gathering observational effectiveness data. Hybrid type 3 trials are best suited to interventions supported by strong “indirect” efficacy or effectiveness data whose rapid implementation is being encouraged by prevailing policy or culture. 18 In the case of the PFP program, FHCC provides strong indirect evidence that HCC may be effective. Additionally, clinical guidelines already strongly recommend exercise for Parkinson’s and the PFP program has already been implemented at over 100 sites around the country. 19 Consistent with the type 3 hybrid trial design, our primary outcomes were implementation measures and our secondary outcomes were exploratory effectiveness measures. We hypothesized that with our enhanced implementation strategy, PFP HCC could be implemented with high gym fidelity and participant adherence in a community-based setting and would be safe, affordable, and sustainable. If such implementation was achieved, we hypothesized HCC would be effective – ie would lead to motor, cognitive, and quality of life gains similar to those observed in controlled trials utilizing FHCC. Methods: Study Design : We designed a single-arm open-label pragmatic hybrid type 3 clinical trial to test implementation and observe effectiveness of an eight-week PFP intervention in community-based gyms. The trial was prospectively registered on ClinicalTrials.gov, Identifier: NCT03675932. The study is reported according to the Standards for Reporting Implementation Studies (StaRI) checklist. Primary implementation outcomes were protocol adoption, gym fidelity, participant adherence, implementation cost, sustainability, acceptability, and safety. Secondary effectiveness outcomes included measures of motor severity, cognition, and quality of life. Implementation outcomes were evaluated based on data gathered in class and questionnaires completed by instructors/participants. Participants were evaluated for effectiveness outcomes within two weeks pre- and one week post-participation in the classes. The protocol and consent forms were approved by the Partners Human Research Committee. All procedures followed were in accordance with the ethical standards of the responsible institutional or regional committee on human experimentation or in accordance with the Helsinki Declaration of 1975, as revised in 1983. All participants provided written informed consent. Study data were collected and managed using REDCap electronic data capture tools hosted at Partners Healthcare. 32 Implementation Strategy : We recruited gyms in the greater Boston area to implement PFP classes based on their geographic diversity and access to participants with PD. As per PFP protocol, gyms were required to read and sign the PFP licensing agreement. This agreement details general instructions for implementation of the program along with legal requirements for participation. In order to encourage the adoption of the program, we designed an augmented implementation strategy which included the following components: First, staff at each site underwent an in person or by phone 45-minute protocol training. Second, staff attested to viewing a 60-minute video produced by study investigators (KEM) that 1) introduced the clinical features of PD 2) summarized the research behind FHCC 3) detailed how to set up a PFP class. 33 Third, gyms were provided with pre-made handouts detailing the structure of the classes, highlighting exertion targets, and how to record participant bike settings. Fourth, gyms received ongoing study staff support with the opportunity to ask questions regarding implementation. Intervention Similar to several FHCC studies, 24 , 25 , 30 the duration of the intervention was 24 one-hour spin classes over eight to nine weeks. The PFP protocol consists of a 10-minute warm-up, 40-minute main set during which participants target a cadence of 80–90 rpm and an exertion level at either 60–80% of their maximum heart rate or Borg rating of perceived exertion (RPE) between 4–7/10, 34,35 and a 10-minute cool-down. If participants cannot achieve the full protocol, instructors encourage rest breaks to allow safe maximal participation. After the intervention concluded, gyms and participants decided independently if they would continue offering/taking classes. Study Participants Participants were recruited through flyers, referral, PD support groups, websites, and a targeted approach whereby participants were identified by zip codes proximal to gym locations. Full eligibility criteria are detailed in Supplementary Appendix 1 . Participants had a clinically confirmed diagnosis of Hoehn and Yahr stage I-III idiopathic PD while ON anti-parkinsonian medication, and stable medication regimen. Participants agreed not to initiate a new structured exercise plan or new course of physical therapy for the duration of the intervention but could continue any pre-existing exercise routine (including group classes). At the first visit, participants were asked to provide demographic data, medical history, a list of their PD medications, frequency of falls in the week prior, and information about prior exercise experience. They also underwent measures of physical activity and cognition via International Physical Activity Questionnaire-Short Form 36 and the Montreal Cognitive Assessment. 37 These instruments were not used as outcome measures but rather to help characterize the population who chose to participate in the intervention. Primary Endpoints: Implementation Outcomes Adoption of the PFP program was measured by the number of potential participating gyms with spin bikes who ultimately implemented the program. Fidelity of gyms to PFP protocol was measured via direct observation of classes by KEM, as well as each gym’s subjective report of whether they could implement the class as per protocol. Additionally, in-class cadence and RPE data was collected by spin instructors to determine whether gyms were generally meeting cadence and exertion targets with their participants. Instructors had participants rate their exertion using the Borg RPE scale at 1, 20, and 39-minutes into the main set. Average cadence and exertion were measured in this way because community-based classes often lack access to continuous cadence and heart rate monitoring. Participant adherence to the intervention was measured through record of attendance over the 24 offered sessions. We considered those who started the classes, did not withdraw from the study, were not lost to follow up, and completed at least 80% of the sessions to have adhered to the intervention. Cost was estimated based on 1) study staff record of implementation strategy cost and 2) a post study survey querying gyms and participants about intervention costs they incurred. Sustainability was measured via telephone eight weeks after conclusion of the intervention to determine if gyms continued to offer PFP classes and participants continued HCC. Acceptability of the program was measured through Likert scale 7 and free-text questions designed to capture participant and gym subjective experience. Safety was monitored through tracking of adverse events (AE) as reported by instructors. Participants were queried by phone regarding interval AE between weeks 3–6, and eight weeks after the intervention. Serious AE were defined as life-threatening, requiring hospitalization, or leading to a persistent disruption of baseline function. Secondary Endpoints: Effectiveness Outcomes Participants were evaluated within two weeks before (pre-test) and one week after (post-test) the intervention. Participants were tested “ON” medications at the same time of day (within one hour) to reduce medication-related performance fluctuation. Post-test evaluations were not conducted on the last day of class due to previously documented motor and cognitive improvements immediately following a single session of FHCC. 28 A modified version of the Unified Parkinson’s Disease Rating Scale (UPDRS) 38 (excluding rigidity and retropulsion) was used so that it could be videotaped and rated remotely by a movement disorders neurologist blinded to whether the visit was pre- or post-intervention. This modified version has been shown to be reliable and valid, both at cross-sectional time points and longitudinally. 39 Timed Up and Go (TUG) 40 and Trail Making Test (TMT) A & B 41 , 42 were tested. Quality of life was assessed via PROMIS-Global Health v1.1: A 10-item questionnaire that assesses participant reported outcomes regarding their overall (global) health. 43 , 44 This instrument produces physical and mental health T-scores, the distributions of which are standardized such that a 50 represents the mean for the US general population and the standard deviation around that mean is 10 points. This instrument was chosen as a more global assessment than the PD specific Parkinson Disease Questionaire-39 (PDQ-39). Statistical Analysis Implementation outcomes are reported descriptively. To determine independent baseline predictors of adherence, comparison of covariates across adherence was carried out using a Wilcoxon rank-sum test for continuous variables and a Fisher exact test for categorical variables. Effectiveness outcomes were analyzed on an intention to treat basis and tested against the null hypothesis of no change using a mixed effects linear model with a fixed effect for time (pre-test or post-test) random effects for site and participant. Effectiveness outcomes aside from PROMIS global health are reported as estimated mean change in scores. If the true adherence proportion is 80% we calculated that a sample of 30 participants would provide an estimate of the true adherence with a confidence interval of 0.31 (0.61–0.92). We also calculated that a sample size of 30 participants would provide 80% power to reject the null hypothesis of no change in UPDRS scores compared to an alternative hypothesis of 3.3 points mean change using a significance level of 5% (two-tailed) and a standard deviation of 6.0. Previously reported data in exercise studies for PD indicate that UPDRS scores will have a standard deviation of 6.0 for the change from baseline to week eight when measured OFF medication. 30 We expected a smaller standard deviation since we utilized a modified version of the UPDRS and tested participants ON medication. Comparison to a hypothesized value of no change was based on previous studies that have shown no improvement in UPDRS scores for those participating in voluntary exercise. 29 , 30 Results Baseline characteristics of gyms Figure 1 describes gym recruitment and participation. 34 gyms were considered potential participants of the study, of which only 6 agreed to participate and completed the implementation training. Ultimately, only four gyms (including three Young Men’s Christian Association (YMCA) gyms) completed the study. The largest barrier to gym recruitment (10 gyms) was inability of the gyms to obtain permission of a governing association (needed to sign the licensing contract for PFP). The majority of the rest of the gyms who declined to participate (8 gyms) did not provide us with a reason for their unwillingness. Two important structural barriers we identified were lack of spin bikes and lack of a handicap accessible gym entrance. Baseline characteristics of participants 48 participants were pre-screened for eligibility. 19 of those participants declined to participate, most commonly due to inconvenient class time or location. Figure 2 depicts participant participation as well as adherence. Baseline characteristics of the 27 enrolled participants are listed in Table 1 . Participants were older, highly educated white adults with moderate disease severity. At baseline this cohort already had a high level of physical activity measured using the IPAQ-sf. Four participants had fallen one or more times in the week prior to the baseline assessment. 93% (n = 25) of participants had prior experience on a road or stationary bike with 78% (n = 21) endorsing comfort cycling outdoors on a road or bike path. Only 17% (n = 4) had ever previously participated in a spin class and only one of those individuals for a frequency of three times a week or more. Table 1 Participant Characteristics Characteristic All Participants (n = 27) Tolerated Intervention (n = 14) Did Not Tolerate Intervention (n = 10) p Age (years) 68.1 (8.05) 69.4 (8.53) 65.0 (7.62) 0.259 Sex (% female) 30% (8) 14% (2) 50% (5) 0.085 White race, non-Hispanic ethnicity 100% (27) 100% (14) 100% (10) 1.000 Bachelor’s degree or higher 78% (21) 64.3% (9) 90% (9) 0.341 Body mass index (kg/m 2 ) 26.1 (4.45) 27.5 (3.91) 24.8 (4.89) 0.122 Hoehn and Yahr stage I II III 19% (5) 67% (18) 14% (4) 14% (2) 64% (9) 21% (3) 30% (3) 60% (6) 10% (1) 0.250 Time since PD diagnosis (years) 5.8 (5.51) 5.6 (5.54) 6.2(6.51) 0.703 Duration of symptoms (years) 7.4 (5.58) 7.6 (6.19) 7.8 (5.63) 0.664 Implanted deep brain stimulator 7% (2) 7% (1) 0.0% (0) 1.000 Levodopa equivalent daily dose (LEDD) (mg) 487.9 (439.30) 469.8 (458.49) 465.1 (271.36) 0.618 Baseline Montreal Cognitive Assessment Score (/30) 25.63 (3.40) 26.0 (3.51) 24.9 (3.75) 0.237 Baseline IPAQ-sf Level of Physical Activity High Moderate Low 56% (15) 33% (9) 11% (3) 57.1% (8) 35.7% (5) 7.1% (1) 50.0% (5) 20.0% (2) 30.0% (3) 0.715 Baseline PROMIS global health Physical T-score Mental T-score 48.7 (7.21) 51.1 (8.39) 49.3 (7.41) 50.0 (7.60) 46.6 (4.83) 51.4 (10.14) 0.575 0.368 IPAQ-sf: International Physical Activity Questionnaire – short form. PROMIS: Participant-Reported Outcomes Measurement Information System. All measures reported as Percent (n) or Mean (SD) except PROMIS is reported as T-scores. PROMIS scores of 48.7 and 51.1 can be interpreted to mean physical and mental health of this cohort fell near the national average. P values reflect comparison between characteristics of those who tolerated the intervention as compared to those who did not. Three participants enrolled in the trial but were not able to undertake the intervention as their gym dropped out. Their data is not reflected in the adherence comparison but is reflected in the second column detailing baseline characteristics of all participants. Protocol violations Six participants violated the protocol eight times including increasing anti-parkinsonian medication (n = 3), starting a new round of physical therapy (n = 4), and starting a new exercise program (n = 1). These participants were included in the safety, adherence, and effectiveness analyses. Primary endpoints: Implementation Outcomes Adoption Only Gym A elected to start the PFP program from scratch. Gyms B and D converted their current PD cycling classes to PFP protocol; Gym C was already executing the PFP program per protocol and agreed to participate in the study with novel participants. Staff at all four participating gyms completed protocol training and attested to watching the training video. Gym staff reported the video was helpful and motivating, but too long. Fidelity : Gym B implemented the PFP protocol as prescribed (ie: participants were coached to complete 10 minute warm up, 40 minute main set at average cadence of 80–90 rpm for the entire time , and 10 minute cool down). The other three gyms found the protocol too difficult for most participants to achieve and adapted the protocol to include interval training (eg: 1-minute on, 1-minute off). Average cadences are shown in Figs. 3 and 4 . Participants in gyms C and A were below cadence targets in early classes, but by the last week of the study, all four gyms achieved an average between 75–85 rpm, just shy of the 80–90 rpm target. On average, across all four sites participants achieved the target RPE at 1-minute into the main set only 3% of the time. Half way through the main set the target was achieved 78% of the time. One-minute before the end of the main set the target was achieved 93% of the time and exceeded 15% percent of the time. Adherence 14 of the 24 participants (58% ; 95% CI = 39–78%) who started classes completed at least 80% of the classes (our pre-specified definition of adherence). Baseline participant characteristics did not differ significantly between those who adhered to the study and those who did not (Table 1 ). The most common reasons for non-adherence were medical conditions that arose over the course of the study and schedule conflicts (Fig. 2 ). Nearly all participants travelled to class by car: 83% driving themselves and 13% driven by someone else. Average one-way transit distance was 10.8 miles (SD 9.31) and time 21.9 minutes (SD 11.62). Classes were offered starting mid-morning through early afternoon; 78% of participants found these times convenient. Implementation Cost : The cost of the implementation strategy included: cost of video production (~ $ 5000), time required to develop the video and additional training materials (~ 40 hours of investigator time) and time required for ongoing support of the gyms in their initial implementation (~ 1 hr investigator time per gym per week for the three weeks surrounding first class date). Intervention cost : All YMCAs chose to offer the program as an included benefit of membership. One YMCA opted to offer the program for free for the 8 weeks of the research study and thereafter charge gym membership fees to continue participation. One YMCA allowed non-members to participate for a fee of $ 100 for the 8 week session. The non-YMCA charged $ 11 per class; participants there estimated they spent on average $ 238.75 in tuition for the 8 week program. At the conclusion of the study participants were asked via written exit-survey how much they would consider to be a reasonable and sustainable amount to pay for this type of program. 18 participants chose to answer and considered an average of $ 5.50 per class (range $ 0–30) to be a reasonable and sustainable amount to pay for this type of program. Gyms estimated that cost to produce an 8 week class session ranged from $ 1500 - $ 2,200, with the majority allocated to cover salary for the instructor. Other cost components were bike lease fees, cleaning supplies, heart rate monitors, and marketing. Sustainability All four gyms opted to continue offering the program and were still offering it at eight weeks post. 18 of 23 (78%) participants who completed the post-survey evaluation continued to practice HCC after the end of the intervention (89% of those individuals riding at their study-site). 13 of 23 (56%) participants were cycling at least once during the eighth week post. Acceptability : All four gyms ‘strongly agreed’ that they enjoyed offering the PFP program and that it was easy to implement. Gyms agreed (‘somewhat agreed’ to ‘strongly agreed’) that participants achieved target cadence and experienced motor and cardiovascular gains. Of the 23 participants who completed the post-survey: 96% agreed they enjoyed participating in the program and 87% agreed they would continue participating if they could. 70% agreed their mood improved; 83% agreed their endurance improved. Supplementary Appendix 2 further details participant responses. In free text response, 43% of participants listed camaraderie as something they liked best about the program while 26% cited the instructor and 22% cited the structure as favorite parts of the program. Other likes included: access, the challenge, the facility, motor benefit, music, participating in research, and ‘everything.’ The most common dislike was saddle soreness cited by 35% of participants. 30% of participants said there was ‘nothing’ they disliked about the program. 17% disliked traveling to participate. Selected comments made by participants during AE check-ins are listed in Supplementary Appendix 3. Safety/Adverse Events 62% of the 24 participants who started classes reported an AE between date of consent and eight weeks-post (Table 2 ). Most of these AE’s were mild and not considered related to the study intervention. Pneumonia requiring hospitalization and post-operative internal bleeding after elective knee surgery were the only two serious AEs; neither was considered related to study interventions. Musculoskeletal and connective tissue disorders (primarily saddle soreness and knee pain) were the most common AEs related to the study interventions and did not affect compliance. Back pain and a broken foot after the end of the study did prevent two participants from continuing cycling after the end of the intervention. No falls occurred during or immediately before or after class, but falls outside of class did limit some participants’ ability to fully participate in subsequent classes. Dyspnea and palpitations required two participants to end a single session early but did not prevent subsequent return to class. Table 2 Frequency List of Reported Adverse Events Event according to system organ class or preferred term Total Events n Participants n (%) Cardiac disorders 2 2 (7%) Dyspnea (1) Palpitations (1) Eye disorders 1 1 (4%) Eye hemorrhage (1) General disorders and administration site conditions 1 1 (4%) Fatigue (1) Infections and infestations 1 1 (4%) Pneumonia requiring hospitalization (1) Injury, poisoning and procedural complication 4 3 (11%) Fall (4) Musculoskeletal and connective tissue disorders 15 12 (44%) Back pain (2) Broken foot (1) Knee pain (3) Leg cramps (1) Saddle soreness (5) Swollen quadriceps (1) Shoulder pain (1) Plantar fasciitis (1) Nervous system disorders 3 3 (11%) Hand numbness (1) Listing to one side on bicycle (1) Loss of consciousness associated with fall (1) Psychiatric disorders 1 1 (4%) Depressed mood (1) Respiratory, thoracic and mediastinal disorders 4 4 (15%) Common cold (1) Sinus infection (2) Vascular disorders 1 1 (4%) Post-operative internal bleeding (1) Parenthetical numbers in the first column indicate absolute number of events. Events were deemed related to study intervention if they occurred during a cycling class or appeared to be temporally related to a class (eg: leg cramps at night but only on the nights after class). The following events were not thought to be related to cycling classes: eye hemorrhage, pneumonia, all falls, broken foot, back pain (1/2), knee pain (1/3), shoulder pain, loss of consciousness, all psychiatric/respiratory/vascular disorders. Listing to one side on the bicycle may be caused by dystonia associated with PD. This phenomenon had been previously witnessed by spin instructors in another individual with PD prior to start of the study. Secondary endpoints: Effectiveness Outcomes Estimates and standard errors of change in effectiveness outcomes from longitudinal regression models are shown in Table 3 . There was no significant improvement in any of the effectiveness outcomes. Table 3 Exploratory Effectiveness Outcomes Outcome Pre-Intervention Estimated Change (95% CI) SE p value PROMIS-global health physical t-score mental t-score 48.15 50.60 -1.81 (-4.87–1.26) -1.97 (-4.96–1.01) 1.53 1.49 0.25 0.20 Modified UPDRS ( / 84) 13.55 0.3 (-1.12–1.67) 0.69 0.67 TUG (sec) 10.86 0.45 (-0.22–1.11) 0.33 0.19 TMT A (sec) TMT B (sec) 41.65 85.44 1.86 (-1.45–5.11) -8.18 (-22.08–4.87) 1.63 6.62 0.27 0.23 Pre-intervention values are reported as mean estimates. Discussion In this implementation study, adoption, fidelity and adherence to the PFP cycling classes was poor. Three out of the four gyms modified the PFP protocol over the course of the trial suggesting that modification of the existing PFP program may be needed for successful translation to a community setting. The program was generally safe, enjoyable, and sustainable, however the intervention failed to demonstrate improvement in effectiveness outcomes. This may have been due to low recruitment of gyms and participants, poor fidelity to the PFP program, poor adherence by participants, or it may suggest that the PFP program is not as effective as the FHCC program. Out of 34 potential participating gyms, only four gyms completed the study. Three out of these four gyms already offered some form of cycling for patients with Parkinson’s prior to the study; only one gym initiated the program from scratch. Failure to obtain permission from a central governing body resulted in 10 gyms’ inability to participate in the needed time frame. Barriers related to cost, equipment, and personnel were observed in a few of the gyms but further research is needed to determine additional barriers to gym participation. Future implementation of novel exercise programming for individuals with PD may benefit from a participatory design approach which would allow earlier identification of barriers to implementation. Our implementation strategy of enhanced training had poor yield in improving fidelity to the PFP protocol. A wide variety of cadences within and between sites were recorded. Only Gym B implemented the protocol as specified. We suspect Gym B was able to offer the program per protocol from the beginning because a higher proportion of their participants had prior spin class experience. The other three gyms adapted the intervention into an interval program to allow participants structured rest between attempts to achieve target cadence and exertion. Although this was in violation of the PFP protocol, these adapted interval programs resulted in most participants achieving cadence goals by the end of the eight-week intervention. Based on data collected from the gyms about their adaptations, Gym C developed the most robust interval program. This gym also produced the most tightly grouped participant cadences, which suggests high-reliability of their program design. Future studies could examine a revised PFP protocol that closely mirrors the real-world adaptations made by these gyms. As it took nearly the entire eight weeks to achieve cadence goals with this adapted design, future studies should consider assessing participants and gyms after a longer intervention period. Participant adherence was low (58%) due to adverse events (mostly unrelated to study intervention), scheduling logistics, transportation, and cost (Fig. 2 ). It is unclear how this compares with other studies due to inconsistent or lack of reported adherence data. 45 Future implementation attempts should focus on reducing barriers to adherence by increasing the number of participating gyms or other options for accessing the intervention, and reducing costs. Remote classes using internet connected spin bikes in participant homes could be compared to in-person classes to see whether this will improve adherence (or worsen adherence due to the lack of camaraderie). Cost could be addressed through partnering with philanthropic and community-focused organizations. We found participating YMCAs were more willing to undertake the cost of setting up the programs in part because of their mission to serve the community, experience working with other chronic health conditions, and ability to subsidize programs through fundraising. Limitations Due to poor adoption as discussed above, only 4 gyms participated in our study; as a result, target enrollment of 30 participants was not achieved. Such a small sample of gyms and participants may not have allowed adequate assessment of the program. This study was also limited by the lack of a control group; however, we did not feel that a randomized trial was justified without further pilot data on PFP program implementation. The demographics of the entirely white, highly educated, and baseline-fit cohort also limit generalizability, especially to underserved communities. Finally, although much of the FHCC literature has tested participants OFF medication, we chose to test ON medication because we believed the discomfort to participants in testing OFF medication was not justified for exploratory outcomes. Conclusions The implementation strategy of additional multi-modal training and support in starting a PFP class was insufficient to achieve wide adoption of and high fidelity and adherence to the PFP protocol. Failure to obtain governing organization permission along with unknown barriers prevented broader gym participation. Based on the protocol adaptations made by three of four gyms in this study, modification of the existing PFP protocol to an interval-training format may be necessary. However, a decrease in sustained cadence speed and cardiovascular intensity may lower program efficacy. More research is needed to first establish effectiveness of a revised community-based protocol. This could be accomplished through an iterative participatory design approach with participants and gyms that first identifies a feasible protocol through qualitative methods and then tests effectiveness of this protocol. Once effectiveness is established, implementation of the program should be further studied in partnership with a broad sample of community gyms. Abbreviations AE – Adverse Event FHCC – Forced High Cadence Cycling HCC – High Cadence Cycling H&Y – Hoehn and Yahr Staging of Parkinson Disease IPAQ-sf – International Physical Activity Questionnaire – short form MoCA – Montreal Cognitive Assessment PD – Parkinson Disease PROMIS—Participant-Reported Outcomes Measurement Information System PFP – Pedaling for Parkinson’s ™ RPE – Rating of Perceived Exertion TMT – Trail Making Test TUG – Timed Up and Go UPDRS – Unified Parkinson’s Disease Rating Scale YMCA – Young Men’s Christian Association Declarations Ethics approval and consent to participate: The protocol and consent forms were approved by the Partners Human Research Committee. All procedures followed were in accordance with the ethical standards of the responsible institutional or regional committee on human experimentation or in accordance with the Helsinki Declaration of 1975, as revised in 1983. All participants provided written informed consent. Consent for publication: Not applicable Availability of data and materials: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. Competing interests : KEM, RKJ, and JC declare they have no competing interests. AW has received research funding from the ALS Association, the Parkinson’s Foundation, has participated in clinical trials funded by Acorda, Abbvie, Biogen, Bristol-Myers Squibb, Sanofi/Genzyme, Pfizer, and received consultant payments from Acorda, Mitsubishi Tanabe Pharma and from Accordant. Funding : KEM received funding from the MGH McCance Center for Brain Health in support of this study. The study also received generous financial support from Jim and Lucy Fox. Authors' contributions KEM: Conception, organization, execution of research project; design, review and critique of statistical analysis; writing of first draft of manuscript RKJ: Organization and execution of the research project; review and critique of the manuscript JC: Design and execution of statistical analysis; review and critique of the manuscript AW: Conception, organization, execution of research project; design, review and critique of statistical analysis; review and critique of manuscript Acknowledgements The authors are grateful to the participants and their family members who volunteered in the study. We also gratefully acknowledge the participation and support of the following individuals and organizations in execution of this study: Elizabeth Simpson, BS, Cadent Therapeutics (formerly with The MGH McCance Center for Brain Health); Jonathan Rosand, MD, The MGH McCance Center for Brain Health; Jay Alberts, PhD and A. Elizabeth Jansen, MPH, Cleveland Clinic and Pedaling for Parkinson's™; Nan Little, PhD, Pedaling for Parkinson’s ™; Michelle Rose and Paul Batista, MGH Photography; Nancy O’Brien of the Cambridge YMCA in Cambridge, MA; Robert Haff, Janet Buckley, Lisa Bonney, Gene Cadman, Meridith Lasko and Stacie Peugh of the YMCA Cape Cod in Barnstable, MA; Diego Nascimento and Janice Naimey of Malden YMCA in Malden, MA; Brett Miller and Anna Dunbar of 110 Fitness in Rockland, MA; Eric Abella, Jennifer Smida, Elizabeth Fells of Wellbridge Athletic Club in Cambridge, MA; Sarah Picard, Marcy Schwam and Lauren Pohlmeyer of Lynch/ van Otterloo YMCA in Marblehead, MA. Authors' information KEM is assistant professor of neurology and associate medical director of neurosciences patient experience at Intermountain Healthcare in Salt Lake City, UT. Her research interests include dissemination and implementation of evidence-based practice and the creation of integrated practice units for individuals with Parkinson Disease. References Dorsey ERBB. The Parkinson pandemic-a call to action. JAMA neurology 2018:9–10. Fox SH, Katzenschlager R, Lim SY, et al. International Parkinson and movement disorder society evidence-based medicine review: Update on treatments for the motor symptoms of Parkinson's disease. Movement disorders: official journal of the Movement Disorder Society. 2018;33:1248–66. Ahlskog JEUR. Rasagiline. Parkinson neuroprotection, and delayed-start trials: still no satisfaction? Neurology 2010:1143–48. Ahlskog JE. Does vigorous exercise have a neuroprotective effect in Parkinson. disease? Neurology. 2011;77:288–94. Ahlskog JE. Aerobic Exercise: Evidence for a Direct Brain Effect to Slow Parkinson Disease Progression. Mayo Clinic proceedings 2018;93:360 – 72. Schenkman M, Moore CG, Kohrt WM, et al. Effect of High-Intensity Treadmill Exercise on Motor Symptoms in Patients With De Novo Parkinson Disease: A Phase 2 Randomized Clinical Trial. JAMA neurology. 2018;75:219–26. McKee KE, Hackney ME. The effects of adapted tango on spatial cognition and disease severity in Parkinson's disease. Journal of motor behavior. 2013;45:519–29. Hackney ME, Earhart GM. Tai Chi improves balance and mobility in people with Parkinson disease. Gait Posture. 2008;28:456–60. Li F, Harmer P, Fitzgerald K, et al. Tai chi and postural stability in patients with Parkinson's disease. N Engl J Med. 2012;366:511–9. Combs SA, Diehl MD, Staples WH, et al. Boxing training for patients with Parkinson disease: a case series. Physical therapy. 2011;91:132–42. Domingos J, Radder D, Riggare S, et al. Implementation of a Community-Based Exercise Program for Parkinson Patients: Using Boxing as an Example. Journal of Parkinson's disease 2019. Combs SA, Diehl MD, Chrzastowski C, et al. Community-based group exercise for persons with Parkinson disease: a randomized controlled trial. NeuroRehabilitation. 2013;32:117–24. van Eijkeren FJ, Reijmers RS, Kleinveld MJ, Minten A, Bruggen JP, Bloem BR. Nordic walking improves mobility in Parkinson's disease. Movement disorders: official journal of the Movement Disorder Society. 2008;23:2239–43. Monteiro EP, Franzoni LT, Cubillos DM, et al. Effects of Nordic walking training on functional parameters in Parkinson's disease: a randomized controlled clinical trial. Scand J Med Sci Sports. 2017;27:351–8. Schmitz-Hubsch T, Pyfer D, Kielwein K, Fimmers R, Klockgether T, Wullner U. Qigong exercise for the symptoms of Parkinson's disease: a randomized, controlled pilot study. Movement disorders: official journal of the Movement Disorder Society. 2006;21:543–8. Perez-de la Cruz S, Garcia Luengo AV, Lambeck J. Effects of an Ai Chi fall prevention programme for patients with Parkinson's disease. Neurologia. 2016;31:176–82. Kurt EE, Buyukturan B, Buyukturan O, Erdem HR, Tuncay F. Effects of Ai Chi on balance, quality of life, functional mobility, and motor impairment in patients with Parkinson's disease . Disabil Rehabil 2018;40:791–7. Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Medical care. 2012;50:217–26. Pedaling for Parkinson's. 2019. (Accessed 23 July 2019, at pedalingforparkinsons.org.). Snijders AH, Bloem BR. Images in clinical medicine. Cycling for freezing of gait. N Engl J Med. 2010;362:e46. Snijders AH, van Kesteren M, Bloem BR. Cycling is less affected than walking in freezers of gait. J Neurol Neurosurg Psychiatry. 2012;83:575–6. Alberts JL, Linder SM, Penko AL, Lowe MJ, Phillips M. It is not about the bike, it is about the pedaling: forced exercise and Parkinson's disease. Exerc Sport Sci Rev. 2011;39:177–86. Beall EB, Lowe MJ, Alberts JL, et al. The effect of forced-exercise therapy for Parkinson's disease on motor cortex functional connectivity. Brain connectivity. 2013;3:190–8. McGough EL, Robinson CA, Nelson MD, et al. A Tandem Cycling Program: Feasibility and Physical Performance Outcomes in People With Parkinson Disease. Journal of neurologic physical therapy: JNPT. 2016;40:223–9. Miller Koop M, Rosenfeldt AB, Alberts JL. Mobility improves after high intensity aerobic exercise in individuals with Parkinson's disease. Journal of the neurological sciences. 2019;399:187–93. Harper SA, Dowdell BT, Kim JH, Pollock BS, Ridgel AL. Non-Motor Symptoms after One Week of High Cadence Cycling in Parkinson's Disease. International journal of environmental research and public health 2019;16. Ridgel AL, Kim CH, Fickes EJ, Muller MD, Alberts JL. Changes in executive function after acute bouts of passive cycling in Parkinson's disease. J Aging Phys Act. 2011;19:87–98. Ridgel AL, Abdar HM, Alberts JL, Discenzo FM, Loparo KA. Variability in cadence during forced cycling predicts motor improvement in individuals with Parkinson's disease. IEEE transactions on neural systems rehabilitation engineering: a publication of the IEEE Engineering in Medicine Biology Society. 2013;21:481–9. Ridgel AL, Phillips RS, Walter BL, Discenzo FM, Loparo KA. Dynamic High-Cadence Cycling Improves Motor Symptoms in Parkinson's Disease. Front Neurol. 2015;6:194. Ridgel AL, Vitek JL, Alberts JL. Forced, not voluntary, exercise improves motor function in Parkinson's disease patients. Neurorehabilit Neural Repair. 2009;23:600–8. Uygur M, Bellumori M, LeNoir K, Poole K, Pretzer-Aboff I, Knight CA. Immediate effects of high-speed cycling intervals on bradykinesia in Parkinson's disease. Physiother Theory Pract. 2015;31:77–82. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42:377–81. How to Start a Pedaling for Parkinson's Program at Your Local Gym. 2018. (Accessed 23 July 2019, at https://youtu.be/NpVDwDXnJsg .). Borg GA. Perceived exertion: a note on "history" and methods. Medicine science in sports. 1973;5:90–3. Penko AL, Barkley JE, Koop MM, Alberts JL. Borg scale is valid for ratings of perceived exertion for individuals with Parkinson's disease. International journal of exercise science. 2017;10:76–86. Craig CL, Marshall AL, Sjostrom M, et al. International physical activity questionnaire: 12-country reliability and validity. Med Sci sports Exerc. 2003;35:1381–95. Chou KL, Amick MM, Brandt J, et al. A recommended scale for cognitive screening in clinical trials of Parkinson's disease. Movement disorders: official journal of the Movement Disorder Society. 2010;25:2501–7. Fahn S, Elton RL Unified Parkinson’s Disease Rating Scale.. In: Fahn CDM, M. Goldstein, & D. B. Calne ed. Recent developments in Parkinson’s disease Florham Park, NJ: Macmillian Healthcare Information; 1987. Abdolahi A, Scoglio N, Killoran A, Dorsey ER, Biglan KM. Potential reliability and validity of a modified version of the Unified Parkinson's Disease Rating Scale that could be administered remotely. Parkinsonism Relat Disord. 2013;19:218–21. Shumway-Cook A, Brauer S, Woollacott M. Predicting the probability for falls in community-dwelling older adults using the Timed Up & Go Test. Physical therapy. 2000;80:896–903. Lezak M. Neuropsychological Assessment (3d ed). Oxford: Oxford University Press; 1995. Reitan R, Wolfson D. The Halstead-Reitan Neuropsychological Test Battery: Theory and clinical interpretation. Tucson: Neuropsychology Press; 1993. Cella D, Riley W, Stone A, et al. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005–2008. J Clin Epidemiol. 2010;63:1179–94. Hays RD, Bjorner JB, Revicki DA, Spritzer KL, Cella D. Development of physical and mental health summary scores from the patient-reported outcomes measurement information system (PROMIS) global items. Quality of life research: an international journal of quality of life aspects of treatment care rehabilitation. 2009;18:873–80. Allen NE, Sherrington C, Suriyarachchi GD, Paul SS, Song J, Canning CG. Exercise and motor training in people with Parkinson's disease: a systematic review of participant characteristics, intervention delivery, retention rates, adherence, and adverse events in clinical trials. Parkinson's disease. 2012;2012:854328. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-29382","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research","associatedPublications":[],"authors":[{"id":582772,"identity":"7ae5ab35-2567-4d87-ab5f-5233ebfe2e8f","order_by":1,"name":"Kathleen McKee","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABAklEQVRIie3QMUvDQBjG8bcE4nLiJicn/QZCRbippF/lPQ7iIi5dMnQ4l3QRXPtxAgeZDm8VBEkJOGd0sfq2AaXCpbgJ3h8Cl+HHkwtALPYH4wApNP05oWfKAEZ31TBJUsBvkm+J+RWxu9MgOVv6usFieguntp10hT+/WFpaKV4yEyCC6aMJunwOIr9SK/fMpFNE3FyHyBh0ylVplRE3iT0uiVRERiXq0IeNT1oim4+evG8emfTrYSL4dsVUO6LpXzH51K9kweuvWsmx1qqku1ze15oIraBDDBHu1SvvFpl6ELrlb4tsJv31uukKnIXIV+neG00oc9D87PBKLBaL/Zc+AaYiWoKhyG0/AAAAAElFTkSuQmCC","orcid":"https://orcid.org/0000-0002-8354-151X","institution":"Intermountain Health Care Inc","correspondingAuthor":true,"submittingAuthor":false,"prefix":"","firstName":"Kathleen","middleName":"","lastName":"McKee","suffix":""},{"id":582773,"identity":"dd894f02-be05-4219-ae61-c28f3a141882","order_by":2,"name":"Remy K Johnson","email":"","orcid":"","institution":"Massachusetts General Hospital","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Remy","middleName":"K","lastName":"Johnson","suffix":""},{"id":582774,"identity":"c448bd6e-100d-43e0-8ad7-dc8c213e8d2e","order_by":3,"name":"James Chan","email":"","orcid":"","institution":"Massachusetts General Hospital","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"James","middleName":"","lastName":"Chan","suffix":""},{"id":582775,"identity":"efc6c18c-d348-4bff-89f3-8d90c598cbe1","order_by":4,"name":"Anne-Marie Wills","email":"","orcid":"","institution":"Massachusetts General Hospital","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Anne-Marie","middleName":"","lastName":"Wills","suffix":""}],"badges":[],"createdAt":"2020-05-15 12:33:24","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-29382/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-29382/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":1137733,"identity":"8d56eb67-5d6a-4dbb-899b-46e8ebf5c620","added_by":"auto","created_at":"2020-05-20 15:01:32","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":62956,"visible":true,"origin":"","legend":"Gym Recruitment and Participation. Recruitment, retention, and participation of community-based gyms is depicted in this diagram. 34 gyms were contacted regarding participation in the study. Four gyms (including three YMCAs) ultimately completed the study.","description":"","filename":"fig1.png","url":"https://assets-eu.researchsquare.com/files/rs-29382/v1/fig1.png"},{"id":1137735,"identity":"1d843932-d5c4-40e7-8177-4677692b7e29","added_by":"auto","created_at":"2020-05-20 15:01:33","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":49927,"visible":true,"origin":"","legend":"Participant Participation and Adherence. All participants who enrolled were analyzed with intention to treat (ITT) analysis. Medical reasons for inability to tolerate the class included arthritis, back pain, and complication from elective surgery.","description":"","filename":"fig2.png","url":"https://assets-eu.researchsquare.com/files/rs-29382/v1/fig2.png"},{"id":1137736,"identity":"7b3389cc-2d9d-4331-a41e-1a08f4fc3c4c","added_by":"auto","created_at":"2020-05-20 15:01:33","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":216908,"visible":true,"origin":"","legend":"Individual Average Cadence per Class. Each individuals’ average cadence per class is graphed along with participants from the same study site.","description":"","filename":"figure3.png","url":"https://assets-eu.researchsquare.com/files/rs-29382/v1/figure3.png"},{"id":1137737,"identity":"f2bec58b-6b96-476f-bc7b-6af7565c148f","added_by":"auto","created_at":"2020-05-20 15:01:33","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":173992,"visible":true,"origin":"","legend":"Average Cadence per Class per Site. Average cadence per class is compared across sites.","description":"","filename":"figure4.png","url":"https://assets-eu.researchsquare.com/files/rs-29382/v1/figure4.png"},{"id":13504452,"identity":"91f9db7e-cce1-4863-923c-256e5f249258","added_by":"auto","created_at":"2021-09-16 23:23:20","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1065721,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-29382/v1/a385f91c-0dcd-4dc5-96ba-b6d3adba7668.pdf"},{"id":1137734,"identity":"429174ba-a829-41c8-bd2c-e9773db30ee7","added_by":"auto","created_at":"2020-05-20 15:01:33","extension":"docx","order_by":0,"title":"","display":"","copyAsset":false,"role":"supplement","size":25981,"visible":true,"origin":"","legend":"","description":"","filename":"SupplementaryAppendix1.docx","url":"https://assets-eu.researchsquare.com/files/rs-29382/v1/SupplementaryAppendix1.docx"},{"id":1137732,"identity":"aac4a5ad-b423-4290-bbf5-1e93bd2d334e","added_by":"auto","created_at":"2020-05-20 15:01:32","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"supplement","size":119688,"visible":true,"origin":"","legend":"","description":"","filename":"StARIchecklistcompleted.pdf","url":"https://assets-eu.researchsquare.com/files/rs-29382/v1/StARIchecklistcompleted.pdf"}],"financialInterests":"","formattedTitle":"High-Cadence Cycling for Parkinson Disease: A Single-Arm Hybrid Implementation and Effectiveness Clinical Trial in the Community Setting","fulltext":[{"header":"Contributions To The Literature","content":"\u003cul\u003e\n\u003cli\u003eExercise therapy for Parkinson Disease (PD) improves motor symptoms and may be disease-modifying. Numerous studies have demonstrated the efficacy of exercise, but few have examined implementation and effectiveness in the community.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cul\u003e\n\u003cli\u003eThis trial examined the impact of a multi-modal strategy to enhance implementation of a community-based cycling program for PD, and observed effectiveness of the intervention.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cul\u003e\n\u003cli\u003eDespite the enhanced implementation strategy, very few gyms agreed to implement the program, gym fidelity to the protocol was poor, and effectiveness was not observed. Insights gained from participating gyms\u0026rsquo; modification to the protocol suggest changes to the protocol that could improve effectiveness.\u0026nbsp; \u0026nbsp;\u0026nbsp;Further research is needed to better identify barriers to implementation.\u003c/li\u003e\n\u003c/ul\u003e"},{"header":"Background","content":" \u003cp\u003eParkinson Disease (PD) is a common neurodegenerative disorder. Progressive rigidity, tremor, slowness, and falls, along with myriad non-motor symptoms rob patients of quality of life.\u003csup\u003e\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u003c/sup\u003e Pharmacologic therapy can mitigate symptoms but has not been shown to protect the brain from further damage and degeneration.\u003csup\u003e\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e,\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u003c/sup\u003e Non-pharmacologic therapy\u0026mdash;in particular exercise\u0026mdash;can also improve symptoms. There is speculation that exercise may even slow disease progression and protect neurons.\u003csup\u003e\u003cspan additionalcitationids=\"CR5\" citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u003c/sup\u003e While many exercises such as dance,\u003csup\u003e\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u003c/sup\u003e tai-chi,\u003csup\u003e\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e,\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u003c/sup\u003e running,\u003csup\u003e\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u003c/sup\u003e boxing,\u003csup\u003e\u003cspan additionalcitationids=\"CR11\" citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u003c/sup\u003e Nordic walking,\u003csup\u003e\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e,\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e\u003c/sup\u003e qigong,\u003csup\u003e\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e\u003c/sup\u003e and aquatic exercise\u003csup\u003e\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e,\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e\u003c/sup\u003e have demonstrated efficacy in small clinical trials, few studies\u003csup\u003e\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u003c/sup\u003e have examined the implementation and effectiveness of these interventions in the real-world setting. Lack of evidence regarding feasibility and effectiveness of exercise may be one barrier to its routine prescription for individuals with PD.\u003c/p\u003e \u003cp\u003eHybrid trials blending implementation and effectiveness research may shorten the time gap between research discovery and routine uptake. Based on the framework proposed by Curran et al. in their 2012 paper\u003csup\u003e\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e\u003c/sup\u003e detailing methods for blending clinical effectiveness and implementation research, we designed a type 3 hybrid trial to test implementation and observe effectiveness of the Pedaling for Parkinson\u0026rsquo;s\u0026trade; (PFP) program\u003csup\u003e\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e\u003c/sup\u003e\u0026mdash;a community-based high-cadence cycling intervention.\u003c/p\u003e \u003cp\u003eWe chose to study the PFP cycling program for two reasons. First, cycling may be especially beneficial because it is often inexplicably but remarkably preserved in individuals with advanced PD who would never be able to run or complete many of the other exercise interventions available.\u003csup\u003e\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e,\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e\u003c/sup\u003e Second, PFP was designed based on the results of several clinical trials examining forced high cadence cycling (FHCC), which have been found to be effective at improving Parkinson\u0026rsquo;s symptoms. While PFP does not utilize FHCC as part of its program, the PFP protocol employs (non-forced) high cadence cycling (HCC). However, this methodology has never been studied in a clinical trial.\u003c/p\u003e \u003cp\u003eMultiple small controlled trials have demonstrated that FHCC can ameliorate motor symptoms in individuals with PD as measured by the Unified Parkinson\u0026rsquo;s Disease Rating Scale-Part\u0026nbsp;III and Timed up and Go.\u003csup\u003e\u003cspan additionalcitationids=\"CR23 CR24 CR25 CR26 CR27 CR28 CR29 CR30\" citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e\u003c/sup\u003e In FHCC, individuals with PD pedal with either a tandem co-rider or a motor providing external augmentation at a cadence of 80\u0026ndash;90 revolutions per minute (rpm)\u0026mdash;which is faster than most individuals would pedal on their own. Although the rate is augmented, cycling on either device is an active, not passive, activity. In comparing FHCC versus cycling at a self-selected cadence on a stationary indoor bicycle, most of the published literature has found that, despite similar cardiovascular exertion in the two modes, improved motor symptoms are only observed in the forced-cadence modality.\u003csup\u003e26,29\u0026minus;31\u003c/sup\u003e One recent study did demonstrate gains in both forced and voluntary groups, but it was noted that the voluntary group self-selected to pedal at a cadence near the target achieved by the forced group.\u003csup\u003e\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eDespite the noted benefit of FHCC, the tandem or motor-augmented bicycle equipment required to implement this protocol in the community is not readily available or affordable. Based on his research of FHCC at The Cleveland Clinic, Jay Alberts, PhD along with Cathy Frazier, a person with Parkinson\u0026rsquo;s, launched The Pedaling for Parkinson\u0026rsquo;s\u0026trade; (PFP) program,\u003csup\u003e\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e\u003c/sup\u003e as an accessible and affordable alternative to FHCC. In PFP, individuals with PD are verbally coached to achieve moderate-exertion, high-cadence cycling (HCC) on solo-rider \u0026ldquo;spin\u0026rdquo; bikes. This differs from FHCC because there is no physical augmentation, only auditory and social cues encouraging participants to pedal at a high rate.\u003c/p\u003e \u003cp\u003eAlthough anecdotal evidence suggests participants in existing PFP programs enjoy the classes, dissemination of the intervention remains limited and the effectiveness of the program has not been established. Even though written instructions on how to run the PFP program are available, informal discussion with gyms that had already implemented a Parkinson\u0026rsquo;s cycling program revealed they had sought out additional instruction in starting their program. This additional support was obtained either directly from the volunteer coordinator running PFP, from a class participant who had taken part in a PFP elsewhere, or from a for-profit company not affiliated with PFP that charged a fee to support setting up a PD cycling program. Based on this information, we hypothesized that community gyms might be more willing to implement the program with additional support that would empower them to realize that they could implement the program without specialized knowledge of Parkinson\u0026rsquo;s Disease and within their existing infrastructure. We therefore developed an implementation strategy of enhanced multi-modal training coupled with ongoing local support to supplement the existing written PFP start-up materials.\u003c/p\u003e \u003cp\u003eWe designed a type 3 hybrid trial to test our implementation strategy while gathering observational effectiveness data. Hybrid type 3 trials are best suited to interventions supported by strong \u0026ldquo;indirect\u0026rdquo; efficacy or effectiveness data whose rapid implementation is being encouraged by prevailing policy or culture.\u003csup\u003e\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e\u003c/sup\u003e In the case of the PFP program, FHCC provides strong indirect evidence that HCC may be effective. Additionally, clinical guidelines already strongly recommend exercise for Parkinson\u0026rsquo;s and the PFP program has already been implemented at over 100 sites around the country.\u003csup\u003e\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eConsistent with the type 3 hybrid trial design, our primary outcomes were implementation measures and our secondary outcomes were exploratory effectiveness measures. We hypothesized that with our enhanced implementation strategy, PFP HCC could be implemented with high gym fidelity and participant adherence in a community-based setting and would be safe, affordable, and sustainable. If such implementation was achieved, we hypothesized HCC would be effective \u0026ndash; ie would lead to motor, cognitive, and quality of life gains similar to those observed in controlled trials utilizing FHCC.\u003c/p\u003e "},{"header":"Methods:","content":" \u003cp\u003e \u003cem\u003eStudy Design\u003c/em\u003e: We designed a single-arm open-label pragmatic hybrid type 3 clinical trial to test implementation and observe effectiveness of an eight-week PFP intervention in community-based gyms. The trial was prospectively registered on ClinicalTrials.gov, Identifier: NCT03675932. The study is reported according to the Standards for Reporting Implementation Studies (StaRI) checklist. Primary implementation outcomes were protocol adoption, gym fidelity, participant adherence, implementation cost, sustainability, acceptability, and safety. Secondary effectiveness outcomes included measures of motor severity, cognition, and quality of life.\u003c/p\u003e \u003cp\u003eImplementation outcomes were evaluated based on data gathered in class and questionnaires completed by instructors/participants. Participants were evaluated for effectiveness outcomes within two weeks pre- and one week post-participation in the classes. The protocol and consent forms were approved by the Partners Human Research Committee. All procedures followed were in accordance with the ethical standards of the responsible institutional or regional committee on human experimentation or in accordance with the Helsinki Declaration of 1975, as revised in 1983. All participants provided written informed consent. Study data were collected and managed using REDCap electronic data capture tools hosted at Partners Healthcare.\u003csup\u003e\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003cp\u003e \u003cem\u003eImplementation Strategy\u003c/em\u003e: We recruited gyms in the greater Boston area to implement PFP classes based on their geographic diversity and access to participants with PD. As per PFP protocol, gyms were required to read and sign the PFP licensing agreement. This agreement details general instructions for implementation of the program along with legal requirements for participation. In order to encourage the adoption of the program, we designed an augmented implementation strategy which included the following components: First, staff at each site underwent an in person or by phone 45-minute protocol training. Second, staff attested to viewing a 60-minute video produced by study investigators (KEM) that 1) introduced the clinical features of PD 2) summarized the research behind FHCC 3) detailed how to set up a PFP class.\u003csup\u003e\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e\u003c/sup\u003e Third, gyms were provided with pre-made handouts detailing the structure of the classes, highlighting exertion targets, and how to record participant bike settings. Fourth, gyms received ongoing study staff support with the opportunity to ask questions regarding implementation.\u003c/p\u003e \u003cp\u003e \u003cstrong\u003eIntervention\u003c/strong\u003e \u003cp\u003eSimilar to several FHCC studies,\u003csup\u003e\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e,\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e,\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e\u003c/sup\u003e the duration of the intervention was 24 one-hour spin classes over eight to nine weeks. The PFP protocol consists of a 10-minute warm-up, 40-minute main set during which participants target a cadence of 80\u0026ndash;90\u0026nbsp;rpm and an exertion level at either 60\u0026ndash;80% of their maximum heart rate or Borg rating of perceived exertion (RPE) between 4\u0026ndash;7/10,\u003csup\u003e34,35\u003c/sup\u003e and a 10-minute cool-down. If participants cannot achieve the full protocol, instructors encourage rest breaks to allow safe maximal participation. After the intervention concluded, gyms and participants decided independently if they would continue offering/taking classes.\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eStudy Participants\u003c/strong\u003e \u003cp\u003eParticipants were recruited through flyers, referral, PD support groups, websites, and a targeted approach whereby participants were identified by zip codes proximal to gym locations. Full eligibility criteria are detailed in \u003cb\u003eSupplementary Appendix 1\u003c/b\u003e. Participants had a clinically confirmed diagnosis of Hoehn and Yahr stage I-III idiopathic PD while ON anti-parkinsonian medication, and stable medication regimen. Participants agreed not to initiate a new structured exercise plan or new course of physical therapy for the duration of the intervention but could continue any pre-existing exercise routine (including group classes).\u003c/p\u003e \u003c/p\u003e \u003cp\u003eAt the first visit, participants were asked to provide demographic data, medical history, a list of their PD medications, frequency of falls in the week prior, and information about prior exercise experience. They also underwent measures of physical activity and cognition via International Physical Activity Questionnaire-Short Form\u003csup\u003e\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e\u003c/sup\u003e and the Montreal Cognitive Assessment.\u003csup\u003e\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e\u003c/sup\u003e These instruments were not used as outcome measures but rather to help characterize the population who chose to participate in the intervention.\u003c/p\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003ePrimary Endpoints: Implementation Outcomes\u003c/h2\u003e \u003cp\u003e \u003cem\u003eAdoption\u003c/em\u003e of the PFP program was measured by the number of potential participating gyms with spin bikes who ultimately implemented the program. \u003cem\u003eFidelity\u003c/em\u003e of gyms to PFP protocol was measured via direct observation of classes by KEM, as well as each gym\u0026rsquo;s subjective report of whether they could implement the class as per protocol. Additionally, in-class cadence and RPE data was collected by spin instructors to determine whether gyms were generally meeting cadence and exertion targets with their participants. Instructors had participants rate their exertion using the Borg RPE scale at 1, 20, and 39-minutes into the main set. Average cadence and exertion were measured in this way because community-based classes often lack access to continuous cadence and heart rate monitoring. Participant \u003cem\u003eadherence\u003c/em\u003e to the intervention was measured through record of attendance over the 24 offered sessions. We considered those who started the classes, did not withdraw from the study, were not lost to follow up, and completed at least 80% of the sessions to have adhered to the intervention.\u003c/p\u003e \u003cp\u003e \u003cem\u003eCost\u003c/em\u003e was estimated based on 1) study staff record of implementation strategy cost and 2) a post study survey querying gyms and participants about intervention costs they incurred. \u003cem\u003eSustainability\u003c/em\u003e was measured via telephone eight weeks after conclusion of the intervention to determine if gyms continued to offer PFP classes and participants continued HCC. \u003cem\u003eAcceptability\u003c/em\u003e of the program was measured through Likert scale\u003csup\u003e\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u003c/sup\u003e and free-text questions designed to capture participant and gym subjective experience. \u003cem\u003eSafety\u003c/em\u003e was monitored through tracking of adverse events (AE) as reported by instructors. Participants were queried by phone regarding interval AE between weeks 3\u0026ndash;6, and eight weeks after the intervention. Serious AE were defined as life-threatening, requiring hospitalization, or leading to a persistent disruption of baseline function.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eSecondary Endpoints: Effectiveness Outcomes\u003c/h2\u003e \u003cp\u003eParticipants were evaluated within two weeks before (pre-test) and one week after (post-test) the intervention. Participants were tested \u0026ldquo;ON\u0026rdquo; medications at the same time of day (within one hour) to reduce medication-related performance fluctuation. Post-test evaluations were not conducted on the last day of class due to previously documented motor and cognitive improvements immediately following a single session of FHCC.\u003csup\u003e\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e\u003c/sup\u003e A modified version of the Unified Parkinson\u0026rsquo;s Disease Rating Scale (UPDRS)\u003csup\u003e\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e\u003c/sup\u003e (excluding rigidity and retropulsion) was used so that it could be videotaped and rated remotely by a movement disorders neurologist blinded to whether the visit was pre- or post-intervention. This modified version has been shown to be reliable and valid, both at cross-sectional time points and longitudinally.\u003csup\u003e\u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e\u003c/sup\u003e Timed Up and Go (TUG) \u003csup\u003e\u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e\u003c/sup\u003e and Trail Making Test (TMT) A \u0026amp; B\u003csup\u003e\u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e,\u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e\u003c/sup\u003e were tested. Quality of life was assessed via PROMIS-Global Health v1.1: A 10-item questionnaire that assesses participant reported outcomes regarding their overall (global) health.\u003csup\u003e\u003cspan citationid=\"CR43\" class=\"CitationRef\"\u003e43\u003c/span\u003e,\u003cspan citationid=\"CR44\" class=\"CitationRef\"\u003e44\u003c/span\u003e\u003c/sup\u003e This instrument produces physical and mental health T-scores, the distributions of which are standardized such that a 50 represents the mean for the US general population and the standard deviation around that mean is 10 points. This instrument was chosen as a more global assessment than the PD specific Parkinson Disease Questionaire-39 (PDQ-39).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eStatistical Analysis\u003c/h2\u003e \u003cp\u003eImplementation outcomes are reported descriptively. To determine independent baseline predictors of adherence, comparison of covariates across adherence was carried out using a Wilcoxon rank-sum test for continuous variables and a Fisher exact test for categorical variables. Effectiveness outcomes were analyzed on an intention to treat basis and tested against the null hypothesis of no change using a mixed effects linear model with a fixed effect for time (pre-test or post-test) random effects for site and participant. Effectiveness outcomes aside from PROMIS global health are reported as estimated mean change in scores.\u003c/p\u003e \u003cp\u003eIf the true adherence proportion is 80% we calculated that a sample of 30 participants would provide an estimate of the true adherence with a confidence interval of 0.31 (0.61\u0026ndash;0.92). We also calculated that a sample size of 30 participants would provide 80% power to reject the null hypothesis of no change in UPDRS scores compared to an alternative hypothesis of 3.3 points mean change using a significance level of 5% (two-tailed) and a standard deviation of 6.0. Previously reported data in exercise studies for PD indicate that UPDRS scores will have a standard deviation of 6.0 for the change from baseline to week eight when measured OFF medication.\u003csup\u003e\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e\u003c/sup\u003e We expected a smaller standard deviation since we utilized a modified version of the UPDRS and tested participants ON medication. Comparison to a hypothesized value of no change was based on previous studies that have shown no improvement in UPDRS scores for those participating in voluntary exercise.\u003csup\u003e\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e,\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003c/div\u003e "},{"header":"Results","content":" \u003cp\u003e \u003cstrong\u003eBaseline characteristics of gyms\u003c/strong\u003e \u003cp\u003eFigure\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e describes gym recruitment and participation. 34 gyms were considered potential participants of the study, of which only 6 agreed to participate and completed the implementation training. Ultimately, only four gyms (including three Young Men\u0026rsquo;s Christian Association (YMCA) gyms) completed the study. The largest barrier to gym recruitment (10 gyms) was inability of the gyms to obtain permission of a governing association (needed to sign the licensing contract for PFP). The majority of the rest of the gyms who declined to participate (8 gyms) did not provide us with a reason for their unwillingness. Two important structural barriers we identified were lack of spin bikes and lack of a handicap accessible gym entrance.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eBaseline characteristics of participants\u003c/strong\u003e \u003cp\u003e48 participants were pre-screened for eligibility. 19 of those participants declined to participate, most commonly due to inconvenient class time or location. Figure\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e depicts participant participation as well as adherence. Baseline characteristics of the 27 enrolled participants are listed in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. Participants were older, highly educated white adults with moderate disease severity. At baseline this cohort already had a high level of physical activity measured using the IPAQ-sf. Four participants had fallen one or more times in the week prior to the baseline assessment. 93% (n\u0026thinsp;=\u0026thinsp;25) of participants had prior experience on a road or stationary bike with 78% (n\u0026thinsp;=\u0026thinsp;21) endorsing comfort cycling outdoors on a road or bike path. Only 17% (n\u0026thinsp;=\u0026thinsp;4) had ever previously participated in a spin class and only one of those individuals for a frequency of three times a week or more.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eParticipant Characteristics\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCharacteristic\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAll Participants\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;27)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eTolerated Intervention (n\u0026thinsp;=\u0026thinsp;14)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eDid Not Tolerate Intervention (n\u0026thinsp;=\u0026thinsp;10)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cem\u003ep\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge (years)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e68.1 (8.05)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e69.4 (8.53)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e65.0 (7.62)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.259\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSex (% female)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e30% (8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e14% (2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e50% (5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.085\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWhite race, non-Hispanic ethnicity\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e100% (27)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e100% (14)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e100% (10)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e1.000\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBachelor\u0026rsquo;s degree or higher\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e78% (21)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e64.3% (9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e90% (9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.341\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBody mass index (kg/m\u003csup\u003e2\u003c/sup\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e26.1 (4.45)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e27.5 (3.91)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e24.8 (4.89)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.122\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHoehn and Yahr stage\u003c/p\u003e \u003cp\u003eI\u003c/p\u003e \u003cp\u003eII\u003c/p\u003e \u003cp\u003eIII\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e19% (5)\u003c/p\u003e \u003cp\u003e67% (18)\u003c/p\u003e \u003cp\u003e14% (4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e14% (2)\u003c/p\u003e \u003cp\u003e64% (9)\u003c/p\u003e \u003cp\u003e21% (3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e30% (3)\u003c/p\u003e \u003cp\u003e60% (6)\u003c/p\u003e \u003cp\u003e10% (1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.250\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTime since PD diagnosis (years)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5.8 (5.51)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5.6 (5.54)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e6.2(6.51)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.703\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDuration of symptoms (years)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7.4 (5.58)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7.6 (6.19)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e7.8 (5.63)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.664\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eImplanted deep brain stimulator\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7% (2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7% (1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.0% (0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e1.000\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eLevodopa equivalent daily dose (LEDD) (mg)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e487.9 (439.30)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e469.8 (458.49)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e465.1 (271.36)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.618\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBaseline Montreal Cognitive Assessment Score (/30)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e25.63 (3.40)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e26.0 (3.51)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e24.9 (3.75)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.237\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBaseline IPAQ-sf Level of Physical Activity\u003c/p\u003e \u003cp\u003eHigh\u003c/p\u003e \u003cp\u003eModerate\u003c/p\u003e \u003cp\u003eLow\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e56% (15)\u003c/p\u003e \u003cp\u003e33% (9)\u003c/p\u003e \u003cp\u003e11% (3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e57.1% (8)\u003c/p\u003e \u003cp\u003e35.7% (5)\u003c/p\u003e \u003cp\u003e7.1% (1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e50.0% (5)\u003c/p\u003e \u003cp\u003e20.0% (2)\u003c/p\u003e \u003cp\u003e30.0% (3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.715\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBaseline PROMIS global health\u003c/p\u003e \u003cp\u003ePhysical T-score\u003c/p\u003e \u003cp\u003eMental T-score\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e48.7 (7.21)\u003c/p\u003e \u003cp\u003e51.1 (8.39)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e49.3 (7.41)\u003c/p\u003e \u003cp\u003e50.0 (7.60)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e46.6 (4.83)\u003c/p\u003e \u003cp\u003e51.4 (10.14)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.575\u003c/p\u003e \u003cp\u003e0.368\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"5\"\u003eIPAQ-sf: International Physical Activity Questionnaire \u0026ndash; short form. PROMIS: Participant-Reported\u003c/td\u003e\u003c/tr\u003e \u003ctr\u003e\u003ctd colspan=\"5\"\u003eOutcomes Measurement Information System. All measures reported as Percent (n) or Mean (SD)\u003c/td\u003e\u003c/tr\u003e \u003ctr\u003e\u003ctd colspan=\"5\"\u003eexcept PROMIS is reported as T-scores. PROMIS scores of 48.7 and 51.1 can be interpreted to\u003c/td\u003e\u003c/tr\u003e \u003ctr\u003e\u003ctd colspan=\"5\"\u003emean physical and mental health of this cohort fell near the national average. P values reflect comparison between characteristics of those who tolerated the intervention as compared to those who did not. Three participants enrolled in the trial but were not able to undertake the intervention as their gym dropped out. Their data is not reflected in the adherence comparison but is reflected in the second column detailing baseline characteristics of all participants.\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eProtocol violations\u003c/strong\u003e \u003cp\u003eSix participants violated the protocol eight times including increasing anti-parkinsonian medication (n\u0026thinsp;=\u0026thinsp;3), starting a new round of physical therapy (n\u0026thinsp;=\u0026thinsp;4), and starting a new exercise program (n\u0026thinsp;=\u0026thinsp;1). These participants were included in the safety, adherence, and effectiveness analyses.\u003c/p\u003e \u003c/p\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003ePrimary endpoints: Implementation Outcomes\u003c/h2\u003e \u003cp\u003e \u003cstrong\u003eAdoption\u003c/strong\u003e \u003cp\u003eOnly Gym A elected to start the PFP program from scratch. Gyms B and D converted their current PD cycling classes to PFP protocol; Gym C was already executing the PFP program per protocol and agreed to participate in the study with novel participants. Staff at all four participating gyms completed protocol training and attested to watching the training video. Gym staff reported the video was helpful and motivating, but too long.\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cem\u003eFidelity\u003c/em\u003e: Gym B implemented the PFP protocol as prescribed (ie: participants were coached to complete 10 minute warm up, 40 minute main set at average cadence of 80\u0026ndash;90\u0026nbsp;rpm \u003cem\u003efor the entire time\u003c/em\u003e, and 10 minute cool down). The other three gyms found the protocol too difficult for most participants to achieve and adapted the protocol to include interval training (eg: 1-minute on, 1-minute off). Average cadences are shown in Figs.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003e and \u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e4\u003c/span\u003e. Participants in gyms C and A were below cadence targets in early classes, but by the last week of the study, all four gyms achieved an average between 75\u0026ndash;85\u0026nbsp;rpm, just shy of the 80\u0026ndash;90\u0026nbsp;rpm target. On average, across all four sites participants achieved the target RPE at 1-minute into the main set only 3% of the time. Half way through the main set the target was achieved 78% of the time. One-minute before the end of the main set the target was achieved 93% of the time and exceeded 15% percent of the time.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eAdherence\u003c/strong\u003e \u003cp\u003e14 of the 24 participants (58% ; 95% CI\u0026thinsp;=\u0026thinsp;39\u0026ndash;78%) who started classes completed at least 80% of the classes (our pre-specified definition of adherence). Baseline participant characteristics did not differ significantly between those who adhered to the study and those who did not (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). The most common reasons for non-adherence were medical conditions that arose over the course of the study and schedule conflicts (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003c/p\u003e \u003cp\u003eNearly all participants travelled to class by car: 83% driving themselves and 13% driven by someone else. Average one-way transit distance was 10.8 miles (SD 9.31) and time 21.9 minutes (SD 11.62). Classes were offered starting mid-morning through early afternoon; 78% of participants found these times convenient.\u003c/p\u003e \u003cp\u003e \u003cem\u003eImplementation Cost\u003c/em\u003e: The cost of the implementation strategy included: cost of video production (~\u003cspan\u003e$\u003c/span\u003e5000), time required to develop the video and additional training materials (~\u0026thinsp;40 hours of investigator time) and time required for ongoing support of the gyms in their initial implementation (~\u0026thinsp;1 hr investigator time per gym per week for the three weeks surrounding first class date). \u003cem\u003eIntervention cost\u003c/em\u003e: All YMCAs chose to offer the program as an included benefit of membership. One YMCA opted to offer the program for free for the 8 weeks of the research study and thereafter charge gym membership fees to continue participation. One YMCA allowed non-members to participate for a fee of \u003cspan\u003e$\u003c/span\u003e100 for the 8 week session. The non-YMCA charged \u003cspan\u003e$\u003c/span\u003e11 per class; participants there estimated they spent on average \u003cspan\u003e$\u003c/span\u003e238.75 in tuition for the 8 week program. At the conclusion of the study participants were asked via written exit-survey how much they would consider to be a reasonable and sustainable amount to pay for this type of program. 18 participants chose to answer and considered an average of \u003cspan\u003e$\u003c/span\u003e5.50 per class (range \u003cspan\u003e$\u003c/span\u003e0\u0026ndash;30) to be a reasonable and sustainable amount to pay for this type of program. Gyms estimated that cost to produce an 8 week class session ranged from \u003cspan\u003e$\u003c/span\u003e1500 - \u003cspan\u003e$\u003c/span\u003e2,200, with the majority allocated to cover salary for the instructor. Other cost components were bike lease fees, cleaning supplies, heart rate monitors, and marketing.\u003c/p\u003e \u003cp\u003e \u003cstrong\u003eSustainability\u003c/strong\u003e \u003cp\u003eAll four gyms opted to continue offering the program and were still offering it at eight weeks post. 18 of 23 (78%) participants who completed the post-survey evaluation continued to practice HCC after the end of the intervention (89% of those individuals riding at their study-site). 13 of 23 (56%) participants were cycling at least once during the eighth week post.\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cem\u003eAcceptability\u003c/em\u003e: All four gyms \u0026lsquo;strongly agreed\u0026rsquo; that they enjoyed offering the PFP program and that it was easy to implement. Gyms agreed (\u0026lsquo;somewhat agreed\u0026rsquo; to \u0026lsquo;strongly agreed\u0026rsquo;) that participants achieved target cadence and experienced motor and cardiovascular gains. Of the 23 participants who completed the post-survey: 96% agreed they enjoyed participating in the program and 87% agreed they would continue participating if they could. 70% agreed their mood improved; 83% agreed their endurance improved. \u003cb\u003eSupplementary Appendix 2\u003c/b\u003e further details participant responses.\u003c/p\u003e \u003cp\u003eIn free text response, 43% of participants listed camaraderie as something they liked best about the program while 26% cited the instructor and 22% cited the structure as favorite parts of the program. Other likes included: access, the challenge, the facility, motor benefit, music, participating in research, and \u0026lsquo;everything.\u0026rsquo; The most common dislike was saddle soreness cited by 35% of participants. 30% of participants said there was \u0026lsquo;nothing\u0026rsquo; they disliked about the program. 17% disliked traveling to participate. Selected comments made by participants during AE check-ins are listed in \u003cb\u003eSupplementary Appendix 3.\u003c/b\u003e\u003c/p\u003e \u003cp\u003e \u003cstrong\u003eSafety/Adverse Events\u003c/strong\u003e \u003cp\u003e62% of the 24 participants who started classes reported an AE between date of consent and eight weeks-post (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). Most of these AE\u0026rsquo;s were mild and not considered related to the study intervention. Pneumonia requiring hospitalization and post-operative internal bleeding after elective knee surgery were the only two serious AEs; neither was considered related to study interventions. Musculoskeletal and connective tissue disorders (primarily saddle soreness and knee pain) were the most common AEs related to the study interventions and did not affect compliance. Back pain and a broken foot after the end of the study did prevent two participants from continuing cycling after the end of the intervention. No falls occurred during or immediately before or after class, but falls outside of class did limit some participants\u0026rsquo; ability to fully participate in subsequent classes. Dyspnea and palpitations required two participants to end a single session early but did not prevent subsequent return to class.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eFrequency List of Reported Adverse Events\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEvent according to system organ class or preferred term\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eTotal Events\u003c/p\u003e \u003cp\u003en\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eParticipants n (%)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eCardiac disorders\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (7%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDyspnea (1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePalpitations (1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eEye disorders\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (4%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEye hemorrhage (1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eGeneral disorders and administration site conditions\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (4%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFatigue (1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eInfections and infestations\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (4%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePneumonia requiring hospitalization (1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eInjury, poisoning and procedural complication\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 (11%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFall (4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eMusculoskeletal and connective tissue disorders\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e15\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e12 (44%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBack pain (2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBroken foot (1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eKnee pain (3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eLeg cramps (1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSaddle soreness (5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSwollen quadriceps (1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eShoulder pain (1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePlantar fasciitis (1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eNervous system disorders\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 (11%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHand numbness (1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eListing to one side on bicycle (1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eLoss of consciousness associated with fall (1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003ePsychiatric disorders\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (4%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDepressed mood (1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eRespiratory, thoracic and mediastinal disorders\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4 (15%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCommon cold (1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSinus infection (2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eVascular disorders\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (4%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePost-operative internal bleeding (1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"3\"\u003eParenthetical numbers in the first column indicate absolute number of events. Events were deemed related\u003c/td\u003e\u003c/tr\u003e \u003ctr\u003e\u003ctd colspan=\"3\"\u003eto study intervention if they occurred during a cycling class or appeared to be temporally related to a class\u003c/td\u003e\u003c/tr\u003e \u003ctr\u003e\u003ctd colspan=\"3\"\u003e(eg: leg cramps at night but only on the nights after class). The following events were not thought to be\u003c/td\u003e\u003c/tr\u003e \u003ctr\u003e\u003ctd colspan=\"3\"\u003erelated to cycling classes: eye hemorrhage, pneumonia, all falls, broken foot, back pain (1/2), knee pain (1/3), shoulder pain, loss of consciousness, all psychiatric/respiratory/vascular disorders. Listing to one side on the\u003c/td\u003e\u003c/tr\u003e \u003ctr\u003e\u003ctd colspan=\"3\"\u003ebicycle may be caused by dystonia associated with PD. This phenomenon had been previously witnessed\u003c/td\u003e\u003c/tr\u003e \u003ctr\u003e\u003ctd colspan=\"3\"\u003eby spin instructors in another individual with PD prior to start of the study.\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003eSecondary endpoints: Effectiveness Outcomes\u003c/h2\u003e \u003cp\u003eEstimates and standard errors of change in effectiveness outcomes from longitudinal regression models are shown in Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e. There was no significant improvement in any of the effectiveness outcomes.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eExploratory Effectiveness Outcomes\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOutcome\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePre-Intervention\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eEstimated Change (95% CI)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eSE\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003ep value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePROMIS-global health\u003c/p\u003e \u003cp\u003ephysical t-score\u003c/p\u003e \u003cp\u003emental t-score\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e48.15\u003c/p\u003e \u003cp\u003e50.60\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-1.81 (-4.87\u0026ndash;1.26)\u003c/p\u003e \u003cp\u003e-1.97 (-4.96\u0026ndash;1.01)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1.53 1.49\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.25\u003c/p\u003e \u003cp\u003e0.20\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eModified UPDRS ( / 84)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e13.55\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026minus;\" colname=\"c3\"\u003e \u003cp\u003e0.3 (-1.12\u0026ndash;1.67)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.69\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.67\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTUG (sec)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e10.86\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026minus;\" colname=\"c3\"\u003e \u003cp\u003e0.45 (-0.22\u0026ndash;1.11)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.33\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.19\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTMT A (sec)\u003c/p\u003e \u003cp\u003eTMT B (sec)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e41.65 85.44\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026minus;\" colname=\"c3\"\u003e \u003cp\u003e1.86 (-1.45\u0026ndash;5.11)\u003c/p\u003e \u003cp\u003e-8.18 (-22.08\u0026ndash;4.87)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e1.63 6.62\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.27\u003c/p\u003e \u003cp\u003e0.23\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"5\"\u003ePre-intervention values are reported as mean estimates.\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e \u003c/div\u003e "},{"header":"Discussion","content":" \u003cp\u003eIn this implementation study, adoption, fidelity and adherence to the PFP cycling classes was poor. Three out of the four gyms modified the PFP protocol over the course of the trial suggesting that modification of the existing PFP program may be needed for successful translation to a community setting. The program was generally safe, enjoyable, and sustainable, however the intervention failed to demonstrate improvement in effectiveness outcomes. This may have been due to low recruitment of gyms and participants, poor fidelity to the PFP program, poor adherence by participants, or it may suggest that the PFP program is not as effective as the FHCC program.\u003c/p\u003e \u003cp\u003eOut of 34 potential participating gyms, only four gyms completed the study. Three out of these four gyms already offered some form of cycling for patients with Parkinson\u0026rsquo;s prior to the study; only one gym initiated the program from scratch. Failure to obtain permission from a central governing body resulted in 10 gyms\u0026rsquo; inability to participate in the needed time frame. Barriers related to cost, equipment, and personnel were observed in a few of the gyms but further research is needed to determine additional barriers to gym participation. Future implementation of novel exercise programming for individuals with PD may benefit from a participatory design approach which would allow earlier identification of barriers to implementation.\u003c/p\u003e \u003cp\u003eOur implementation strategy of enhanced training had poor yield in improving fidelity to the PFP protocol. A wide variety of cadences within and between sites were recorded. Only Gym B implemented the protocol as specified. We suspect Gym B was able to offer the program per protocol from the beginning because a higher proportion of their participants had prior spin class experience. The other three gyms adapted the intervention into an interval program to allow participants structured rest between attempts to achieve target cadence and exertion. Although this was in violation of the PFP protocol, these adapted interval programs resulted in most participants achieving cadence goals by the end of the eight-week intervention.\u003c/p\u003e \u003cp\u003eBased on data collected from the gyms about their adaptations, Gym C developed the most robust interval program. This gym also produced the most tightly grouped participant cadences, which suggests high-reliability of their program design. Future studies could examine a revised PFP protocol that closely mirrors the real-world adaptations made by these gyms. As it took nearly the entire eight weeks to achieve cadence goals with this adapted design, future studies should consider assessing participants and gyms after a longer intervention period.\u003c/p\u003e \u003cp\u003eParticipant adherence was low (58%) due to adverse events (mostly unrelated to study intervention), scheduling logistics, transportation, and cost (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). It is unclear how this compares with other studies due to inconsistent or lack of reported adherence data.\u003csup\u003e\u003cspan citationid=\"CR45\" class=\"CitationRef\"\u003e45\u003c/span\u003e\u003c/sup\u003e Future implementation attempts should focus on reducing barriers to adherence by increasing the number of participating gyms or other options for accessing the intervention, and reducing costs. Remote classes using internet connected spin bikes in participant homes could be compared to in-person classes to see whether this will improve adherence (or worsen adherence due to the lack of camaraderie). Cost could be addressed through partnering with philanthropic and community-focused organizations. We found participating YMCAs were more willing to undertake the cost of setting up the programs in part because of their mission to serve the community, experience working with other chronic health conditions, and ability to subsidize programs through fundraising.\u003c/p\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eLimitations\u003c/h2\u003e \u003cp\u003eDue to poor adoption as discussed above, only 4 gyms participated in our study; as a result, target enrollment of 30 participants was not achieved. Such a small sample of gyms and participants may not have allowed adequate assessment of the program. This study was also limited by the lack of a control group; however, we did not feel that a randomized trial was justified without further pilot data on PFP program implementation. The demographics of the entirely white, highly educated, and baseline-fit cohort also limit generalizability, especially to underserved communities. Finally, although much of the FHCC literature has tested participants OFF medication, we chose to test ON medication because we believed the discomfort to participants in testing OFF medication was not justified for exploratory outcomes.\u003c/p\u003e \u003c/div\u003e "},{"header":"Conclusions","content":" \u003cp\u003eThe implementation strategy of additional multi-modal training and support in starting a PFP class was insufficient to achieve wide adoption of and high fidelity and adherence to the PFP protocol. Failure to obtain governing organization permission along with unknown barriers prevented broader gym participation. Based on the protocol adaptations made by three of four gyms in this study, modification of the existing PFP protocol to an interval-training format may be necessary. However, a decrease in sustained cadence speed and cardiovascular intensity may lower program efficacy. More research is needed to first establish effectiveness of a revised community-based protocol. This could be accomplished through an iterative participatory design approach with participants and gyms that first identifies a feasible protocol through qualitative methods and then tests effectiveness of this protocol. Once effectiveness is established, implementation of the program should be further studied in partnership with a broad sample of community gyms.\u003c/p\u003e "},{"header":"Abbreviations","content":"\u003cp\u003eAE \u0026ndash; Adverse Event\u003c/p\u003e\n\u003cp\u003eFHCC \u0026ndash; Forced High Cadence Cycling\u003c/p\u003e\n\u003cp\u003eHCC \u0026ndash; High Cadence Cycling\u003c/p\u003e\n\u003cp\u003eH\u0026amp;Y \u0026ndash; Hoehn and Yahr Staging of Parkinson Disease\u003c/p\u003e\n\u003cp\u003eIPAQ-sf \u0026ndash; International Physical Activity Questionnaire \u0026ndash; short form\u003c/p\u003e\n\u003cp\u003eMoCA \u0026ndash; Montreal Cognitive Assessment\u003c/p\u003e\n\u003cp\u003ePD \u0026ndash; Parkinson Disease\u003c/p\u003e\n\u003cp\u003ePROMIS\u0026mdash;Participant-Reported Outcomes Measurement Information System\u003c/p\u003e\n\u003cp\u003ePFP \u0026ndash; Pedaling for Parkinson\u0026rsquo;s \u0026trade;\u003c/p\u003e\n\u003cp\u003eRPE \u0026ndash; Rating of Perceived Exertion\u003c/p\u003e\n\u003cp\u003eTMT \u0026ndash; Trail Making Test\u003c/p\u003e\n\u003cp\u003eTUG \u0026ndash; Timed Up and Go\u003c/p\u003e\n\u003cp\u003eUPDRS \u0026ndash; Unified Parkinson\u0026rsquo;s Disease Rating Scale\u003c/p\u003e\n\u003cp\u003eYMCA \u0026ndash; Young Men\u0026rsquo;s Christian Association\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cem\u003eEthics approval and consent to participate:\u003c/em\u003e\u0026nbsp; The protocol and consent forms were approved by the Partners Human Research Committee.\u0026nbsp; All procedures followed were in accordance with the ethical standards of the responsible institutional or regional committee on human experimentation or in accordance with the Helsinki Declaration of 1975, as revised in 1983.\u0026nbsp; All participants provided written informed consent.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eConsent for publication:\u003c/em\u003e Not applicable\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eAvailability of data and materials:\u003c/em\u003e The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eCompeting interests\u003c/em\u003e: KEM, RKJ, and JC declare they have no competing interests.\u0026nbsp; AW has received research funding from the ALS Association, the Parkinson\u0026rsquo;s Foundation, has participated in clinical trials funded by Acorda, Abbvie, Biogen, Bristol-Myers Squibb, Sanofi/Genzyme, Pfizer, and received consultant payments from Acorda, Mitsubishi Tanabe Pharma and from Accordant.\u0026nbsp; \u0026nbsp;\u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eFunding\u003c/em\u003e: KEM received funding from the MGH McCance Center for Brain Health in support of this study.\u0026nbsp; The study also received generous financial support from Jim and Lucy Fox.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eAuthors' contributions\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eKEM: Conception, organization, execution of research project; design, review and critique of statistical analysis; writing of first draft of manuscript\u003c/p\u003e\n\u003cp\u003eRKJ: Organization and execution of the research project; review and critique of the manuscript\u003c/p\u003e\n\u003cp\u003eJC: Design and execution of statistical analysis; review and critique of the manuscript\u003c/p\u003e\n\u003cp\u003eAW: Conception, organization, execution of research project; design, review and critique of statistical analysis; review and critique of manuscript\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eAcknowledgements\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe authors are grateful to the participants and their family members who volunteered in the study.\u0026nbsp; We also gratefully acknowledge the participation and support of the following individuals and organizations in execution of this study: Elizabeth Simpson, BS, Cadent Therapeutics (formerly with The MGH McCance Center for Brain Health); Jonathan Rosand, MD, The MGH McCance Center for Brain Health; Jay Alberts, PhD and A. Elizabeth Jansen, MPH, Cleveland Clinic and Pedaling for Parkinson's\u0026trade;; Nan Little, PhD, Pedaling for Parkinson\u0026rsquo;s \u0026trade;; Michelle Rose and Paul Batista, MGH Photography; Nancy O\u0026rsquo;Brien of the Cambridge YMCA in Cambridge, MA; Robert Haff, Janet Buckley, Lisa Bonney, Gene Cadman, Meridith Lasko and Stacie Peugh of the YMCA Cape Cod in Barnstable, MA; Diego Nascimento and Janice Naimey of Malden YMCA in Malden, MA; Brett Miller and Anna Dunbar of 110 Fitness in Rockland, MA; Eric Abella, Jennifer Smida, Elizabeth Fells of Wellbridge Athletic Club in Cambridge, MA; Sarah Picard, Marcy Schwam and Lauren Pohlmeyer of Lynch/ van Otterloo YMCA in Marblehead, MA.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eAuthors' information \u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eKEM is assistant professor of neurology and associate medical director of neurosciences patient experience at Intermountain Healthcare in Salt Lake City, UT.\u0026nbsp; Her research interests include dissemination and implementation of evidence-based practice and the creation of integrated practice units for individuals with Parkinson Disease.\u0026nbsp;\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e \u003cspan\u003eDorsey ERBB. 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Neurologia. 2016;31:176\u0026ndash;82.\u003c/span\u003e \u003c/li\u003e \u003cli\u003e \u003cspan\u003eKurt EE, Buyukturan B, Buyukturan O, Erdem HR, Tuncay F. Effects of Ai Chi on balance, quality of life, functional mobility, and motor impairment in patients with Parkinson's disease \u0026lt; sup/\u0026gt;. Disabil Rehabil 2018;40:791\u0026ndash;7.\u003c/span\u003e \u003c/li\u003e \u003cli\u003e \u003cspan\u003eCurran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Medical care. 2012;50:217\u0026ndash;26.\u003c/span\u003e \u003c/li\u003e \u003cli\u003e \u003cspan\u003ePedaling for Parkinson's. 2019. (Accessed 23 July 2019, at pedalingforparkinsons.org.).\u003c/span\u003e \u003c/li\u003e \u003cli\u003e \u003cspan\u003eSnijders AH, Bloem BR. Images in clinical medicine. Cycling for freezing of gait. N Engl J Med. 2010;362:e46.\u003c/span\u003e \u003c/li\u003e \u003cli\u003e \u003cspan\u003eSnijders AH, van Kesteren M, Bloem BR. Cycling is less affected than walking in freezers of gait. J Neurol Neurosurg Psychiatry. 2012;83:575\u0026ndash;6.\u003c/span\u003e \u003c/li\u003e \u003cli\u003e \u003cspan\u003eAlberts JL, Linder SM, Penko AL, Lowe MJ, Phillips M. It is not about the bike, it is about the pedaling: forced exercise and Parkinson's disease. Exerc Sport Sci Rev. 2011;39:177\u0026ndash;86.\u003c/span\u003e \u003c/li\u003e \u003cli\u003e \u003cspan\u003eBeall EB, Lowe MJ, Alberts JL, et al. The effect of forced-exercise therapy for Parkinson's disease on motor cortex functional connectivity. Brain connectivity. 2013;3:190\u0026ndash;8.\u003c/span\u003e \u003c/li\u003e \u003cli\u003e \u003cspan\u003eMcGough EL, Robinson CA, Nelson MD, et al. A Tandem Cycling Program: Feasibility and Physical Performance Outcomes in People With Parkinson Disease. Journal of neurologic physical therapy: JNPT. 2016;40:223\u0026ndash;9.\u003c/span\u003e \u003c/li\u003e \u003cli\u003e \u003cspan\u003eMiller Koop M, Rosenfeldt AB, Alberts JL. Mobility improves after high intensity aerobic exercise in individuals with Parkinson's disease. Journal of the neurological sciences. 2019;399:187\u0026ndash;93.\u003c/span\u003e \u003c/li\u003e \u003cli\u003e \u003cspan\u003eHarper SA, Dowdell BT, Kim JH, Pollock BS, Ridgel AL. Non-Motor Symptoms after One Week of High Cadence Cycling in Parkinson's Disease. International journal of environmental research and public health 2019;16.\u003c/span\u003e \u003c/li\u003e \u003cli\u003e \u003cspan\u003eRidgel AL, Kim CH, Fickes EJ, Muller MD, Alberts JL. Changes in executive function after acute bouts of passive cycling in Parkinson's disease. J Aging Phys Act. 2011;19:87\u0026ndash;98.\u003c/span\u003e \u003c/li\u003e \u003cli\u003e \u003cspan\u003eRidgel AL, Abdar HM, Alberts JL, Discenzo FM, Loparo KA. Variability in cadence during forced cycling predicts motor improvement in individuals with Parkinson's disease. IEEE transactions on neural systems rehabilitation engineering: a publication of the IEEE Engineering in Medicine Biology Society. 2013;21:481\u0026ndash;9.\u003c/span\u003e \u003c/li\u003e \u003cli\u003e \u003cspan\u003eRidgel AL, Phillips RS, Walter BL, Discenzo FM, Loparo KA. Dynamic High-Cadence Cycling Improves Motor Symptoms in Parkinson's Disease. Front Neurol. 2015;6:194.\u003c/span\u003e \u003c/li\u003e \u003cli\u003e \u003cspan\u003eRidgel AL, Vitek JL, Alberts JL. Forced, not voluntary, exercise improves motor function in Parkinson's disease patients. Neurorehabilit Neural Repair. 2009;23:600\u0026ndash;8.\u003c/span\u003e \u003c/li\u003e \u003cli\u003e \u003cspan\u003eUygur M, Bellumori M, LeNoir K, Poole K, Pretzer-Aboff I, Knight CA. Immediate effects of high-speed cycling intervals on bradykinesia in Parkinson's disease. Physiother Theory Pract. 2015;31:77\u0026ndash;82.\u003c/span\u003e \u003c/li\u003e \u003cli\u003e \u003cspan\u003eHarris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42:377\u0026ndash;81.\u003c/span\u003e \u003c/li\u003e \u003cli\u003e \u003cspan\u003eHow to Start a Pedaling for Parkinson's Program at Your Local Gym. 2018. (Accessed 23 July 2019, at \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://youtu.be/NpVDwDXnJsg\u003c/span\u003e\u003c/span\u003e.).\u003c/span\u003e \u003c/li\u003e \u003cli\u003e \u003cspan\u003eBorg GA. Perceived exertion: a note on \"history\" and methods. Medicine science in sports. 1973;5:90\u0026ndash;3.\u003c/span\u003e \u003c/li\u003e \u003cli\u003e \u003cspan\u003ePenko AL, Barkley JE, Koop MM, Alberts JL. Borg scale is valid for ratings of perceived exertion for individuals with Parkinson's disease. International journal of exercise science. 2017;10:76\u0026ndash;86.\u003c/span\u003e \u003c/li\u003e \u003cli\u003e \u003cspan\u003eCraig CL, Marshall AL, Sjostrom M, et al. International physical activity questionnaire: 12-country reliability and validity. Med Sci sports Exerc. 2003;35:1381\u0026ndash;95.\u003c/span\u003e \u003c/li\u003e \u003cli\u003e \u003cspan\u003eChou KL, Amick MM, Brandt J, et al. A recommended scale for cognitive screening in clinical trials of Parkinson's disease. Movement disorders: official journal of the Movement Disorder Society. 2010;25:2501\u0026ndash;7.\u003c/span\u003e \u003c/li\u003e \u003cli\u003e \u003cspan\u003eFahn S, Elton RL Unified Parkinson\u0026rsquo;s Disease Rating Scale.. In: Fahn CDM, M. Goldstein, \u0026amp; D. B. Calne ed. Recent developments in Parkinson\u0026rsquo;s disease Florham Park, NJ: Macmillian Healthcare Information; 1987.\u003c/span\u003e \u003c/li\u003e \u003cli\u003e \u003cspan\u003eAbdolahi A, Scoglio N, Killoran A, Dorsey ER, Biglan KM. Potential reliability and validity of a modified version of the Unified Parkinson's Disease Rating Scale that could be administered remotely. Parkinsonism Relat Disord. 2013;19:218\u0026ndash;21.\u003c/span\u003e \u003c/li\u003e \u003cli\u003e \u003cspan\u003eShumway-Cook A, Brauer S, Woollacott M. Predicting the probability for falls in community-dwelling older adults using the Timed Up \u0026amp; Go Test. Physical therapy. 2000;80:896\u0026ndash;903.\u003c/span\u003e \u003c/li\u003e \u003cli\u003e \u003cspan\u003eLezak M. Neuropsychological Assessment (3d ed). Oxford: Oxford University Press; 1995.\u003c/span\u003e \u003c/li\u003e \u003cli\u003e \u003cspan\u003eReitan R, Wolfson D. The Halstead-Reitan Neuropsychological Test Battery: Theory and clinical interpretation. Tucson: Neuropsychology Press; 1993.\u003c/span\u003e \u003c/li\u003e \u003cli\u003e \u003cspan\u003eCella D, Riley W, Stone A, et al. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005\u0026ndash;2008. J Clin Epidemiol. 2010;63:1179\u0026ndash;94.\u003c/span\u003e \u003c/li\u003e \u003cli\u003e \u003cspan\u003eHays RD, Bjorner JB, Revicki DA, Spritzer KL, Cella D. Development of physical and mental health summary scores from the patient-reported outcomes measurement information system (PROMIS) global items. Quality of life research: an international journal of quality of life aspects of treatment care rehabilitation. 2009;18:873\u0026ndash;80.\u003c/span\u003e \u003c/li\u003e \u003cli\u003e \u003cspan\u003eAllen NE, Sherrington C, Suriyarachchi GD, Paul SS, Song J, Canning CG. Exercise and motor training in people with Parkinson's disease: a systematic review of participant characteristics, intervention delivery, retention rates, adherence, and adverse events in clinical trials. Parkinson's disease. 2012;2012:854328.\u003c/span\u003e \u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Parkinson Disease, Exercise, Cadence, Cycling, Implementation, Effectiveness, Hybrid Type 3","lastPublishedDoi":"10.21203/rs.3.rs-29382/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-29382/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eBACKGROUND \u003c/p\u003e\u003cp\u003eEfficacy of exercise to improve motor symptoms in Parkinson Disease (PD) has been established in multiple clinical trials. The Pedaling for Parkinson’s ™ (PFP) program is an existing community-based cycling intervention for individuals with PD. Although the program design was informed by efficacy studies, the implementation and effectiveness of the program have not been studied. We used a hybrid trial, which blends the study of implementation and effectiveness, to study the implementation of PFP in community gyms in the greater Boston area. \u003c/p\u003e\u003cp\u003eMETHODS \u003c/p\u003e\u003cp\u003eThis was a single-arm open-label pragmatic hybrid type 3 clinical trial designed to test implementation and observe clinical effectiveness. The implementation strategy consisted of enhanced multi-modal training and support for community-based gyms to implement the PFP protocol. Individuals with Hoehn and Yahr stage I-III idiopathic PD were recruited to participate. Primary implementation outcomes included adoption, gym fidelity, participant adherence, implementation cost, sustainability, acceptability, and safety. Secondary effectiveness outcomes included disease and quality of life measures. \u003c/p\u003e\u003cp\u003eRESULTS \u003c/p\u003e\u003cp\u003e34 gyms were invited to participate. 4 gyms agreed to participate and implemented the PFP protocol. 24 individuals with idiopathic PD agreed to participate in the study and started classes. The program was implemented safely and sustainably across all sites but with high fidelity at only one of four gyms. 58% of individuals who started classes completed at least 80% of classes. 96% of participants who started classes enjoyed the program and 87% wished to continue. No effectiveness outcomes demonstrated a significant change from pre to post. \u003c/p\u003e\u003cp\u003eCONCLUSION \u003c/p\u003e\u003cp\u003eOur implementation strategy of additional multi-modal training and support in starting a PFP class was insufficient to achieve wide adoption of and high fidelity and adherence to the PFP protocol. However, participating gyms’ modifications of the PFP protocol in this study suggests such protocol modification may be necessary for effective implementation in the community setting. Future studies should first establish effectiveness of a revised PFP protocol. Implementation could then be achieved through a participatory approach in which barriers to gym participation are identified and mitigated early in the implementation process.\u003c/p\u003e","manuscriptTitle":"High-Cadence Cycling for Parkinson Disease: A Single-Arm Hybrid Implementation and Effectiveness Clinical Trial in the Community Setting","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2020-05-20 15:01:20","doi":"10.21203/rs.3.rs-29382/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"b9390c5a-22ce-49c8-a5ae-435021b9fc5c","owner":[],"postedDate":"May 20th, 2020","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[{"id":103455,"name":"Neurology"}],"tags":[],"updatedAt":"2020-09-07T15:39:46+00:00","versionOfRecord":[],"versionCreatedAt":"2020-05-20 15:01:20","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-29382","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-29382","identity":"rs-29382","version":["v1"]},"buildId":"FbvkV6FR0MCFSLy54lSbu","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}