Impact of Personlized Exercise Prescription on Muscle Mass, Physical Function, and Quality of Life in Postoperative Pancreatic Cancer Patients Undergoing da Vinci Robotic Surgery: A Randomized Controlled Trial Protocol

Impact of Personlized Exercise Prescription on Muscle Mass, Physical Function, and Quality of Life in Postoperative Pancreatic Cancer Patients Undergoing da Vinci Robotic Surgery: A Randomized Controlled Trial Protocol | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Impact of Personlized Exercise Prescription on Muscle Mass, Physical Function, and Quality of Life in Postoperative Pancreatic Cancer Patients Undergoing da Vinci Robotic Surgery: A Randomized Controlled Trial Protocol Mengjiao Liu, Tingting Ren This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6252683/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 16 Oct, 2025 Read the published version in Trials → Version 1 posted 6 You are reading this latest preprint version Abstract Background: Pancreatic cancer is characterized by a 5-year survival rate of less than 12%, primarily because of challenges in early diagnosis, which has resulted in a generally poor prognosis for patients. With ongoing advancements in diagnostic and surgical technologies, there is an increasing focus on enhancing the postoperative quality of life for individuals with pancreatic cancer. Although existing research suggests that exercise interventions are safe for this patient population, definitive evidence regarding their efficacy remains insufficient. Consequently, this study aims to conduct a randomized controlled trial to assess the safety and efficacy of exercise interventions in enhancing muscle mass, physical function, and quality of life among patients who have undergone surgery for pancreatic cancer. Methods: A total of 168 eligible postoperative pancreatic cancer patients will be enrolled and randomly allocated in a 1:2 ratio to either the intervention group or the control group. Participants in the intervention group will receive a personalized exercise prescription for a duration of 16 weeks, whereas participants in the control group will not receive any specific exercise prescription or intervention. The primary outcomes of this study include changes in muscle mass, specifically the skeletal muscle index and density, from baseline to week 16, as well as assessments of physical function using the 6-Minute Walk Test (6MWT) and evaluations of quality of life through standardized scale scores. Secondary outcomes comprise assessments using the Functional Assessment of Cancer Therapy Fatigue Scale (FACT-F), the Hospital Anxiety and Depression Scale (HADS), and the Pittsburgh Sleep Quality Index (PSQI). Measurements of outcome indicators other than muscle mass will be conducted at weeks 0, 4, and 12, respectively. Discussion: The impact of the personalized exercise prescription intervention will be evaluated through alterations in primary and secondary outcome indicators at both the 4-week intervention mark and the 12-week follow-up period. This trial aims to offer novel clinical insights into the efficacy of personalized exercise prescriptions in enhancing muscle mass, physical function, and quality of life among postoperative pancreatic cancer patients. Trial registration: Clinical Trial Registry-China ChiCTR2500098709. Registered on 12 March 2025. Pancreatic cancer Da Vinci robot Robotic surgery Exercise prescription aerobic exercise Resistance exercise Physical rehabilitation Quality of life Figures Figure 1 Figure 2 Background Pancreatic cancer (PC) is characterized as a malignant tumor with a poor prognosis and high mortality rate, with a 5-year survival rate of less than 12%(1). According to the 2022 global cancer statistics published by the International Agency for Research on Cancer (IARC)(2), the incidence of PC was approximately 510,566 cases, with mortality reaching 467,005 cases worldwide in the same year. The mortality rate associated with PC has been escalating annually, imposing a substantial disease burden on countries globally. The mortality rate of PC is rising annually, contributing to a substantial disease burden on countries worldwide. PC is characterized by a high incidence rate, high recurrence and metastasis rates, high mortality rate, low early diagnosis rate, low resection rate, low drug effectiveness rate, and low survival rate, collectively referred to as the "three highs and four lows"(3). Consequently, the World Health Organization has classified it as a global public health concern requiring urgent attention, posing significant challenges to national economies(4). Currently, the primary treatment for PC involves surgery combined with radiotherapy, with surgery being the cornerstone of early intervention. However, even after radical resection, there remains a significant risk of recurrence, imposing considerable suffering and economic strain on patients(5). In addition, PC patients may suffer from weight loss, poor glycemic control and weakened digestive function after surgery, and up to 74% of them may develop cachexia, which is manifested as progressive skeletal muscle loss, decreased body fat mass, and unconscious body mass loss, etc., and these symptoms seriously affect the patients' physical functioning and quality of survival(6). Recent research indicates that exercise interventions are safe for individuals with PC and can decrease the risk of tumor-specific mortality by 26% to 69%(7). Additionally, such interventions enhance cardiorespiratory fitness, muscle strength, and endurance in PC patients. Postoperative exercise rehabilitation has been shown to mitigate the risk of complications, such as deep vein thrombosis and pulmonary infections, and to expedite wound healing, thereby improving patients' quality of life. For instance, Nemkov et al(8). implemented a preoperative intervention combining aerobic and resistance exercises in PC patients, resulting in significant improvements in skeletal muscle index, physical function, and muscle mass. Wochner et al(9). A randomized controlled trial was employed to examine the impact of progressive resistance training on interventions in patients with PC, demonstrating similar enhancements in physical function and quality of survival. Luo et al(10). implemented an intervention combining aerobic and resistance training in PC patients, excluding those with a postoperative period of less than three months. This approach led to improvements in physical function, quality of survival, and sleep quality, as well as reductions in fatigue and depression, and mitigated the decline in debilitation and fatigue. A study by Ngo A et al(11). investigated home-based exercise for PC patients, which also resulted in improved quality of survival and physical functioning. However, current research predominantly focuses on non-surgical patients, preoperative rehabilitation for surgical patients, and outcomes of home exercise rehabilitation, with limited studies addressing the effects of perioperative exercise rehabilitation. With the rapid advancement of clinical medical technology, minimally invasive surgery is increasingly becoming a prevalent trend. In comparison to traditional laparoscopic surgery, the da Vinci robotic-assisted approach offers several advantages, including reduced intraoperative bleeding, more comprehensive lymph node dissection, a lower incidence of intermediate openings, and a shorter duration of postoperative hospitalization. These benefits collectively contribute to delaying muscle loss and enhancing patient prognosis(12). According to the Accelerated Rehabilitation Surgery Clinical Practice Guidelines(13), initiating resistance training for post-PC patients—whether in bed, seated, or out of bed—as soon as possible within 24 hours post-surgery is recommended. This early intervention facilitates functional recovery, decreases the length of postoperative hospitalization, shortens the time required to regain preoperative functional status, and ultimately improves the overall mean functional recovery following treatment. Consequently, it is imperative to implement exercise interventions for post-PC patients at the earliest opportunity, while ensuring patient safety. Personalized Exercise Prescription (PEP) refers to an exercise regimen specifically designed to meet the unique needs of an individual, encompassing six fundamental components: exercise frequency (F), exercise intensity (I), exercise time (T), exercise type (T), exercise volume (V), and exercise process (P)(14). For the majority of cancer patients, current guidelines advocate for a minimum of 150 minutes of moderate- to high-intensity aerobic exercise weekly, supplemented by resistance training on at least two days per week(15). Given that the general condition of post-PC patients treatment is often compromised, a more customized exercise prescription is advisable. This approach entails initiating exercise at a low intensity and progressively adjusting to a suitable level of intensity, adhering to the three foundational principles of exercise program design: individualization, gradual progression, and perseverance(16). Furthermore, Ba Duan Jin, a traditional Chinese physical fitness practice, serves as both a moderate-intensity aerobic exercise and a comprehensive method that harmonizes the body, breath, and mind. Empirical studies have demonstrated that Baduanjin can significantly enhance patients' mood and sleep quality(17). Integrating Baduanjin into exercise prescriptions offers distinct advantages not typically found in conventional exercise regimens. Notably, Baduanjin movements are imbued with unique elements of Chinese medicine and qigong, which are readily embraced by patients, thereby enhancing their adherence to exercise routines. In summary, exercise interventions, as potential adjunctive therapies, have demonstrated positive impacts on physical function and quality of life among patients with PC. Nonetheless, there is a paucity of comprehensive research on the application of personalized exercise prescriptions for post-PC patients, particularly concerning the effects of exercise rehabilitation during the perioperative period. To address this research gap, we propose to conduct a randomized controlled trial to evaluate the impact of personalized exercise prescriptions on post-PC patients. Our primary hypothesis posits that personalized exercise prescriptions can ameliorate muscle loss, enhance physical function, and improve the quality of life in these patients. Secondly, we posited that the implementation of personalized exercise prescriptions would mitigate adverse symptoms such as cancer-related fatigue, cancer pain, anxiety, depression, and poor sleep quality in post-PC patients, thereby enhancing their overall quality of life. This study aims to contribute to the development of a more comprehensive and individualized treatment plan for the rehabilitation of post-PC patients. Methods Study design A randomized controlled clinical trial will be conducted at Guizhou Medical University Hospital. Participants will include patients with pathologically confirmed pancreatic cancer who have undergone da Vinci robotic-assisted surgery. These patients will be randomly assigned to either a control group or an experimental group in a 2:1 ratio. The experimental group will receive a 4-week personalized exercise prescription intervention postoperatively, followed by a 12-week follow-up period. In contrast, the control group will receive standard treatment, which includes routine care and early postoperative activities. The flowchart outlining the entire trial is depicted in Figure 1, and the timeline is presented in Figure 2. The study protocol was developed in accordance with the SPIRIT 2013 guidelines(18). Sample size estimation The post-intervention skeletal muscle index was utilized as the primary outcome measure. A differential unequal design (k = 1:2) was employed to allocate participants into the usual care group and the exercise prescription intervention group. Based on data from the literature(8), the intervention was scheduled for a duration of 16 weeks. The expected difference in mean skeletal muscle index between the intervention and control groups was 1.2, with a standard deviation of 3.2. Given these parameters, and assuming a Type I error rate (α) of 0.05 and a statistical power (1 - β) of 80%, while accounting for a 10% dropout rate, a total sample size of 168 participants was determined to be necessary. This included 112 participants in the control group and 56 participants in the experimental group. Sample size calculations were conducted using G-Power software. Recruitment and informed consent Participants for the randomized controlled trial (RCT) were recruited from September 2025 to September 2027 at the Affiliated Hospital of GuiZhou Medical University. Recruitment efforts utilized both digital and traditional methods, including social media platforms and offline advertisements such as posters and health promotion brochures. Eligible patients were included in the study. All participants received the intervention plan and were informed of the study's potential benefits and risks. Prior to randomization, all participants provided written informed consent. The study received ethical approval from the Ethics Committee of Guizhou Medical University Hospital (approval number: 2024-507). Recruitment and informed consent Participants will be eligible for recruitment if they satisfy the following criteria: (1) they are 18 years of age or older; (2) they have a confirmed diagnosis of pancreatic cancer based on pathological examination; (3) they are scheduled to undergo either da Vinci robot-assisted radical surgery or partial resection; (4) they provide written informed consent. Exclusion criteria Participants will be excluded from the study if they meet any of the following criteria: (1) Presence of combined severe organ failure or compromised cardiopulmonary function that precludes the ability to tolerate the training; (2) Diagnosis of extensive tumor metastasis for which only palliative surgery is indicated; (3) Coexisting psychiatric illness, speech disorder, or communication difficulties. Randomisation and allocation concealment A total of 168 eligible patients will be assigned to either the trial or control groups in a 1:2 ratio. Randomization sequences will be generated using Stata software version 17.0. The allocation process will be conducted by a member of the research team who is not involved in the intervention or data collection but possesses statistical expertise. The randomization codes will be concealed within opaque envelopes to ensure that neither the participants nor the intervention implementers are aware of the group assignments until the randomization process is finalized. Blinding This study is structured as a single-blind trial, wherein participants remain unaware of their group assignments throughout the study. Personnel responsible for recruitment, intervention administration, data collection, statistical analysis, and data management will function independently. Additionally, data collectors and statistical analysts will remain blinded to group assignments during both the collection of outcome indicators and the data analysis. All samples and data will be anonymized prior to data collection and statistical analysis. Intervention a.Formation of multidisciplinary teams Assemble a multidisciplinary team comprising exercise prescribers, clinicians, clinical nurses, rehabilitation therapists, and physiotherapists. This team collaboratively developed a personalized exercise prescription program and facilitated the implementation of the intervention. Clinicians were tasked with evaluating the participants' disease status, overall health, and postoperative recovery. Exercise prescribers ensured the program's feasibility, scientific rigor, and standardization. Clinical nurses participated in the intervention's execution and data collection. Rehabilitation therapists and physiotherapists provided guidance on movement training to the patients. b. Personalized Exercise Prescription This study is scheduled to be conducted in the second ward of the Hepatobiliary Surgery Department at the Affiliated Hospital of Guizhou Medical University, with a 16-week exercise prescription intervention planned. Participants will engage in exercise interventions for approximately 45 to 60 minutes, three to five times per week. These sessions will encompass warm-up activities, aerobic exercises, resistance training, stretching exercises, and relaxation techniques. Prior to commencing the intervention, participants will undergo two instructional sessions designed to familiarize them with assessing exercise intensity using the Borg Scale of Perceived Exertion (PRE). Additionally, participants will complete a one-repetition maximum (1-RM) test, with each comprehensive training session lasting approximately 60 minutes. A baseline assessment of participants will be conducted preoperatively, and outcome measures will be collected at enrollment (T0), four weeks postoperatively (T1), and at a 12-week follow-up (T2) to evaluate the efficacy of the exercise intervention. The personalized exercise regimen is structured into four distinct phases: the bed exercise phase, the sitting exercise phase, the standing exercise phase, and the follow-up home exercise phase. During their hospital stay, participants will receive full supervision, while partial supervision will be provided during the follow-up period. The intervention is implemented through a tailored exercise prescription that includes specific guidelines. The intervention was implementedvia a tailored exercise prescription, encompassing comprehensive and specific guidelines regarding the type, frequency, duration, and intensity of the exercises.These details were meticulously documented in an exercise logbook. Each participant was supplied with elastic bands, and daily follow-up telephone consultations were conducted to monitor progress, address emerging issues, and instruc patients on techniques for self-monitoring exercise intensity. Table 1 Exercise prescription Intervention phase Details of intervention Exercise assessment Frequency Intensity Time Type Content of the campaign Bed exercise phase The patient was unable to move independently from a prone to a sitting position after surgery, but active or passive movement of the extremities was possible 2~3 times a week 5~10min Warm-up Shoulder rotation, elbow flexion, wrist rotation, knee flexion and ankle rotation 3~5 times a week 5～10 times/set. 5～10 sets 15~20min Respiratory exercises Respiratory muscle strength and endurance exercises using assisted breathing trainers or abdominal breathing 2~3 times a week Each movement 8~12 times/set, 2~3 sets 15~20min Resistance movement Fist movements, arm lifts, straight leg raises, prone knee flexion and ankle plantarflexion and dorsiflexion movements 2~3 times a week 5~10min Stretching activities Muscle massage relaxation mainly focusing on patient's muscle relaxation Seated movement phase The patient was able to change positions independently (prone to sitting) and to sit at the bedside for 20 min after surgery, but was unable to perform independent ambulation. 2~3 times a week 5~10min Warm-up Same-lying position exercise content 2~3 times a week Single-leg stand for 15s, 3 to 5 reps; 3 to 5 sets of dynamic training movements 15~20min Balance training Static balance training (one-legged standing) and dynamic balance training (assisting the patient in cross walking, parallel walking and semi-tandem walking) 3~5 times a week 5～10 times/set. 5～10 sets 15~20min Respiratory exercises Same-lying position exercise content 2~3 times a week 1~2 sets of 20 repetitions (50-60% 1-RM) 15~20min Resistance movement Exercise content adds bridge exercises, grip strength training and elastic band training to the content of the previous phase. 2~3 times a week Hold the stretched position for at least 20 seconds, with 20-25 second intervals between each session 5~10min Stretching activities Perform some of the seated poses of your yoga training for stretching, such as 1 . Standing position exercise phase The patient can independently get out of bed and walk without uprightness intolerance in standing and walking. 2~3 times a week 5~10min Warm-up Perform large joint activities in various parts of the body 2 . 2~3 times a week Borg score (7 to 12) on the Perceptual-Recognitive Exercise Scale (PRE) 10-20min，increase gradually Aerobic exercise Walking and Ba Duan Jin 1~2 times a week 1~2 sets of 20 repetitions, (50-60% 1-RM) 25~30min Resistance movement Choose from 2 to 3 movements per workout 3 . 2~3 times a week Hold the stretched position for at least 20 seconds, with 20-25 second intervals between each session 10~15min Stretching exercise The main part of the yoga training is to stretch 4 . Home follow-up phase The content of the exercise prescription was the same as above, gradually increasing the number of movements and groups of movements according to the patient's own tolerance ability, and gradually increasing the intensity of the exercise by 5% after 3 sets of 12 repetitions could be completed for 3 consecutive times. Supervision was performed using the Borg score (10-13 points) of the Perceived Exercise Rating Scale (PRE). (NOTE: 1.Perform a gentle lateral flexion of the torso while seated, ensuring to elongate the lateral musculature of the body. Additionally, execute a seated stretch against the wall to effectively target and extend the anterior deltoid and pectoral muscles. 2.The movements include adduction, flexion, and extension of the neck; rotation of the neck and shoulders; flexion of the elbows; rotation of the wrists; flexion and adduction of the hips; flexion of the knees; and rotation of the ankles. 3.Resistance exercises encompass the training of eight primary upper and lower body muscle groups. These exercises include movements such as front arm raises, lateral arm raises, arm curls, overhead presses, chest presses, wall push-ups, squats, and alternating leg lifts performed in both seated and supine positions, utilizing equipment such as dumbbells or elastic bands. 4.Examples of fundamental movements include low lunges, which stretch the front of the hip; side stretches, which strengthen and stretch the back of the leg; easy sitting side stretches, which target the side of the body; one-legged slants, which stretch the calf and back of the ankle; standing on one leg, which stretches the front of the thigh; half pigeon poses, which stretch the outside of the hip; standing against the wall, which stretches the front of the shoulder and chest muscles; bull arm poses, which stretch the front of the shoulder and armpit; and supine twists, which facilitate spinal stretching.) Outcomes a. Primary outcome 1. Muscle Mass The assessment of skeletal muscle mass, including the skeletal muscle index (SMI) and skeletal muscle density (SMD), was conducted utilizing computed tomography (CT) scans. Specifically, CT images were obtained from the midpoint of the third lumbar vertebra (L3) for analysis. These images were quantified using SliceOmatic software (version 5.0, rev-4a2, TomoVision), applying established pixel-density thresholds in Hounsfield units (HUs) to calculate the skeletal muscle cross-sectional area (CSA in cm²), thereby facilitating the evaluation of the patient's muscle mass. 2. Physical Function The patient's physical function was evaluated using the 6-Minute Walk Test (6MWT), a standardized measure for assessing exercise tolerance and gait balance. The 6MWT should be administered indoors within a long, flat, straight, and enclosed corridor. The corridor should ideally be 30 meters in length, with markings placed every 3 meters from the starting point. The start and end points must be distinctly marked with brightly colored tape. Prior to conducting the test, the examiner should be equipped with a stopwatch and essential first aid equipment, such as a first aid kit or an automated external defibrillator. The patient is advised to wear comfortable attire and properly fitting footwear, and to abstain from engaging in strenuous activities for a minimum of two hours prior to the test. If necessary, patients should utilize their usual walking aids, such as crutches, during the test. Baseline measurements of the patient's blood pressure and heart rate should be obtained before the test. At the onset of the test, the patient should position themselves at the starting line, with the timer set for a 6-minute countdown. If required, the procedure should be demonstrated to the patient, and the test should commence once the patient confirms their readiness. During the administration of the 6-minute walk test, it is important not to accompany the patient. Upon completion of the test, the distance covered by the patient should be documented, rounding to the nearest meter. The test should be immediately discontinued if the patient exhibits any of the following symptoms: chest pain, intolerable dyspnea, cramps in the lower limbs, staggering, or pallor. It is essential to recognize the absolute contraindications for the 6-minute walk test, which include unstable angina or myocardial infarction within the preceding month. Relative contraindications include a resting heart rate exceeding 120 beats per minute, a systolic blood pressure greater than 180 mm Hg, and a diastolic blood pressure exceeding 100 mm Hg. The test should not be administered if the patient exhibits any of these contraindications. 3. Quality of Life Quality of survival was assessed using the Quality of Life Core Questionnaire (EORTC QLQ-C30), a pivotal tool developed by the European Organisation for Research and Treatment of Cancer (EORTC) to evaluate the quality of life in cancer patients. In this study, the Chinese version of the EORTC QLQ-C30 was utilized(19). This instrument consists of 30 items across 15 domains, including five functional domains and one domain assessing overall health status, where higher scores indicate better functioning. It also includes three symptom domains and six single-item measures, with higher scores reflecting more severe symptoms. b. Secondary outcomes 1. Anxiety and Depression The study utilized the Hospital Anxiety and Depression Scale (HADS)(20) to evaluate symptoms of anxiety and depression. This instrument is specifically designed for screening purposes and comprises two subscales, each containing seven items. Each item is rated on a scale from 0 to 3, resulting in a total score range of 0 to 21. Scores above 7 indicate the presence of anxiety or depression symptoms, with higher scores signifying greater symptom severity. 2. Cancer-related fatigue To assess cancer-related fatigue, the Chinese version of the Functional Assessment of Cancer Therapy-Fatigue Scale (FACT-F)(21) was employed. This scale consists of 41 items, yielding a total score range of 0 to 164, and is divided into six dimensions: physiological well-being (7 items), social/family well-being (7 items), emotional well-being (5 items), functional well-being (7 items), fatigue (13 items), and relationship with the physician (2 items). 3. Sleep quality the Pittsburgh Sleep Quality Index (PSQI)(22) was used to evaluate patients' sleep quality. The Pittsburgh Sleep Quality Index (PSQI) consists of 19 self-reported items and 5 observer-reported items, which are organized into seven dimensions: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each dimension is evaluated on a scale from 0 to 3, and the sum of these scores forms the total PSQI score, which ranges from 0 to 21, with higher scores indicating poorer sleep quality. c. Safety outcomes At the end of each 4-week treatment period, pertinent adverse events will be recorded, including severe pain, pancreatic fistula, falls, syncope, palpitations, and exacerbations. All adverse events occurring during the study will be addressed appropriately. In the event of a serious adverse event, researchers will recommend that patients seek medical attention if they experience persistent discomfort. Statistical analysis The trial data will be managed by a designated member of the data management team. Initially, the collected data will be entered into Excel to create a database, which will then be imported into SPSS version 29.0 for statistical analysis. All analyses will employ two-sided tests with a significance level set at α = 0.05. An intent-to-treat (ITT) approach will be adopted to evaluate all outcome indicators, with the analysis set including all participants. Missing data will be addressed using the last observation carried forward method for interpolation. Outcome indicators measured as continuous data that conform to a normal distribution will be reported using means and standard deviations, while those not conforming to a normal distribution will be described using medians and interquartile ranges. Categorical variables will be presented as frequencies and percentages. Comparative analyses between the intervention and control groups will be performed to assess differences in baseline socio-demographic characteristics, comorbidities, and tumor stage, utilizing t-tests for continuous variables, chi-square tests for categorical variables, and Fisher's exact tests when appropriate. For the purpose of between-group comparisons at each measurement point within the intervention and control groups, the normality of the data was evaluated using the Shapiro-Wilk test. In instances where the data adhered to a normal distribution, a t-test was utilized to compare the means of two independent samples. Conversely, when the data deviated from a normal distribution, a rank-sum test was employed for comparison. Longitudinal changes in the relevant variables within each group across time points T0, T1, and T2 were analyzed using repeated measures ANOVA. Pairwise comparisons at each measurement point were conducted using the Student-Newman-Keuls (S-N-K) test. Effect size (ES) was calculated to quantify the extent to which the time factor contributed to the variation in each measure within the intervention and control groups. The repeated measures ANOVA revealed an interaction between time and group, necessitating further analysis of the effect of grouping on each measure using analysis of covariance (ANCOVA), with 'grouping' as a fixed factor and 'time' as a covariate. Discussion Pancreatic cancer, a malignancy of the digestive system, is characterized by a poor prognosis, primarily due to its low rate of early detection and high degree of malignancy. The depletion of muscle and adipose tissue in cancer patients significantly influences surgical complications and the long-term prognosis of individuals with pancreatic cancer. A meta-analysis indicates that 41.0% of pancreatic cancer patients develop sarcopenia( 23 ), which can extend hospitalization duration, elevate the risk of complications( 24 ), and may progress to a more severe malignant condition( 25 ). This condition results in reduced muscle mass, diminished physical function, and a lower quality of life for patients with pancreatic cancer. Recent studies have demonstrated that exercise interventions positively affect the prognosis of pancreatic cancer patients( 26 ), by decreasing the incidence of postoperative complications and enhancing cardiopulmonary function and muscle strength. Consequently, these interventions facilitate the recovery of patients' physical function and improve their overall quality of life. Nevertheless, the exercise intervention protocols employed in previous studies exhibit certain limitations: they lack personalization, predominantly emphasize resistance exercise, and are presented in a uniform format, potentially resulting in suboptimal patient adherence. To address these issues, we developed a tailored exercise regimen specifically for postoperative pancreatic cancer patients. This regimen integrates aerobic exercise with resistance training, incorporating the traditional Chinese exercise Ba Duan Jin, thereby diversifying the exercise modalities available to patients. To ensure appropriate exercise intensity, patients were instructed to utilize the Borg scale for fatigue assessment and were provided with heart rate monitors to maintain their exercise within the target heart rate zone. This study is subject to several limitations. Firstly, the personalized nature of the intervention program precluded the possibility of blinding both the implementers and the participants. Secondly, the findings may be subject to potentialbiases arising from the limited sample size and the single-center study design. Nonetheless, this research aims to develop a novel personalized exercise prescription intended to enhance muscle mass, physical function, and quality of life in patients recovering from pancreatic cancer surgery, thereby offering new insights for clinical practice. Declarations Author Contributions Conceptualization and design: Mengjiao Liu. Recruitment: Mengjiao Liu. Investigating Mengjiao Liu. Project Administration: Sara LK Low. Writing- original draft: Mengjiao Liu. Writing-review and editing: Mengjiao Liu. All authors read and approved the final manuscript. Availability of Data and Materials The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. Consent for Publication Consent for publication is not required as there is no details on individuals reported within the manuscript. Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. Funding The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This paper is part of a Master's study and it is supported by Guizhou Medical University School of Nursing, Affiliated Hospital of Guizhou Medical University[Grant Numbers: gyfyhlxz-2024-5]. Trial Status Recruitment of participants started on September 2025. The trial is currently underway and expected to be completed by end of 2027. Ethics Approval and Consent to Participate This study has been approved by The Ethics Committee of the Affiliated Hospital of GuiZhou Medical University (NO: 2024-507). All methods will be conducted in accordance with the ethical standards of the declaration of Helsinki. Informed consent will be obtained from all subjects. Supplemental Material Supplemental material for this article is available online. References Halbrook CJ, Lyssiotis CA, Pasca di Magliano M, Maitra A. Pancreatic cancer: Advances and challenges. Cell. 2023;186(8):1729-54. Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-63. Guishan X. Expert consensus on the molecular diagnosis of early-stage pancreatic cancer(2023 edition). JOURNAL OF CLINICAL HEPATOLOGY. 2024;40(3):473-7. Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. 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The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989;28(2):193-213. Surov A, Wienke A. Prevalence of sarcopenia in patients with solid tumors: A meta-analysis based on 81,814 patients. JPEN J Parenter Enteral Nutr. 2022;46(8):1761-8. Tsukagoshi M, Araki K, Shirabe K. Pancreatic cancer and sarcopenia: a narrative review of the current status. Int J Clin Oncol. 2024;29(8):1055-66. Sakamoto T, Kishino M, Murakami Y, Miyatani K, Hanaki T, Shishido Y, et al. The cachexia index is a prognostic factor for patients with recurrent pancreatic cancer. Surg Today. 2024;54(12):1498-504. Fengjian Z, Cheng C, Ning Z, Heshui W, Bei Z, Xing Z, et al. Exercise interventions for pancreatic cancer patients: a scoping review. JOURNAL OF NURSING SCIENCE. 2023;38(20):116-21. Supplementary Files completedSPIRITchecklist.docx Cite Share Download PDF Status: Published Journal Publication published 16 Oct, 2025 Read the published version in Trials → Version 1 posted Reviewers agreed at journal 29 Apr, 2025 Reviewers invited by journal 29 Apr, 2025 Editor invited by journal 29 Apr, 2025 Editor assigned by journal 25 Mar, 2025 First submitted to journal 24 Mar, 2025 Editorial decision: Minor revision 23 Mar, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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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-6252683","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":449714865,"identity":"663fad6e-fbd5-48ab-ba53-2fa8f4784191","order_by":0,"name":"Mengjiao Liu","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA1ElEQVRIiWNgGAWjYBACfmbGhoMfDP7L2d8/fIA4LZLtzI2PJQqYjRlusCUQp8XgPHuzAc8H5kSGGzwGRLrsMGObhIQBWwLj7J6PN94w2MnpNhDQwdgM1FJgwJPHLHN2s+UchmRjswMEtDAzg22RKGZjyN0mzcNwIHEbIS1sIC08BgaJPQw5z4jTwsPMCPS+QULiDIkcNuK0SDAzAgPZ4ICxAc8xY8s5BkT4xf788QcHP/w5IGfA3vzwxpsKOzmCWlCtJDpqkLSQqmMUjIJRMApGBAAA+ak/CCTkaEEAAAAASUVORK5CYII=","orcid":"https://orcid.org/0009-0006-8544-7988","institution":"Guizhou Medical University","correspondingAuthor":true,"prefix":"","firstName":"Mengjiao","middleName":"","lastName":"Liu","suffix":""},{"id":449714866,"identity":"3c368c2d-02fd-4a3f-b643-b00320673b18","order_by":1,"name":"Tingting Ren","email":"","orcid":"","institution":"The Affiliated Hospital of Guizhou Medical University","correspondingAuthor":false,"prefix":"","firstName":"Tingting","middleName":"","lastName":"Ren","suffix":""}],"badges":[],"createdAt":"2025-03-18 11:37:24","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6252683/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6252683/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s13063-025-09078-0","type":"published","date":"2025-10-16T15:58:20+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":82154621,"identity":"2ee09860-5428-4c99-a5b9-0c183a4d56ed","added_by":"auto","created_at":"2025-05-07 07:32:02","extension":"jpeg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":78765,"visible":true,"origin":"","legend":"\u003cp\u003eFlowchart of the trial\u003c/p\u003e","description":"","filename":"floatimage1.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-6252683/v1/76f026ee32ebc2aa418a30e9.jpeg"},{"id":82152895,"identity":"5a584892-2c60-4c6d-80a6-e9fa3e861079","added_by":"auto","created_at":"2025-05-07 07:24:03","extension":"jpeg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":79825,"visible":true,"origin":"","legend":"\u003cp\u003eSPIRIT figure as recommended by 2013 SPIRIT statement\u003c/p\u003e","description":"","filename":"floatimage2.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-6252683/v1/33cff3821dd42520ac761404.jpeg"},{"id":93956770,"identity":"bd32f7c4-d430-4511-8222-920ccd26a841","added_by":"auto","created_at":"2025-10-20 16:12:18","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":857397,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6252683/v1/17a31405-9a9a-4400-b53b-d1cb0ce1efdf.pdf"},{"id":82152892,"identity":"7f88673a-8f7c-4b71-8991-61f440680580","added_by":"auto","created_at":"2025-05-07 07:24:02","extension":"docx","order_by":4,"title":"","display":"","copyAsset":false,"role":"supplement","size":22238,"visible":true,"origin":"","legend":"","description":"","filename":"completedSPIRITchecklist.docx","url":"https://assets-eu.researchsquare.com/files/rs-6252683/v1/9029c58fc2468ec490a60bd8.docx"}],"financialInterests":"","formattedTitle":"Impact of Personlized Exercise Prescription on Muscle Mass, Physical Function, and Quality of Life in Postoperative Pancreatic Cancer Patients Undergoing da Vinci Robotic Surgery: A Randomized Controlled Trial Protocol","fulltext":[{"header":"Background","content":"\u003cp\u003ePancreatic cancer (PC) is characterized as a malignant tumor with a poor prognosis and high mortality rate, with a 5-year survival rate of less than 12%(1). According to the 2022 global cancer statistics published by the International Agency for Research on Cancer (IARC)(2), the incidence of PC was approximately 510,566 cases, with mortality reaching 467,005 cases worldwide in the same year. The mortality rate associated with PC has been escalating annually, imposing a substantial disease burden on countries globally. The mortality rate of PC is rising annually, contributing to a substantial disease burden on countries worldwide. PC is characterized by a high incidence rate, high recurrence and metastasis rates, high mortality rate, low early diagnosis rate, low resection rate, low drug effectiveness rate, and low survival rate, collectively referred to as the \u0026quot;three highs and four lows\u0026quot;(3). Consequently, the World Health Organization has classified it as a global public health concern requiring urgent attention, posing significant challenges to national economies(4). Currently, the primary treatment for PC involves surgery combined with radiotherapy, with surgery being the cornerstone of early intervention. However, even after radical resection, there remains a significant risk of recurrence, imposing considerable suffering and economic strain on patients(5). In addition, PC patients may suffer from weight loss, poor glycemic control and weakened digestive function after surgery, and up to 74% of them may develop cachexia, which is manifested as progressive skeletal muscle loss, decreased body fat mass, and unconscious body mass loss, etc., and these symptoms seriously affect the patients\u0026apos; physical functioning and quality of survival(6).\u003c/p\u003e\n\u003cp\u003eRecent research indicates that exercise interventions are safe for individuals with PC and can decrease the risk of tumor-specific mortality by 26% to 69%(7). Additionally, such interventions enhance cardiorespiratory fitness, muscle strength, and endurance in PC patients. Postoperative exercise rehabilitation has been shown to mitigate the risk of complications, such as deep vein thrombosis and pulmonary infections, and to expedite wound healing, thereby improving patients\u0026apos; quality of life. For instance, Nemkov et al(8). implemented a preoperative intervention combining aerobic and resistance exercises in PC patients, resulting in significant improvements in skeletal muscle index, physical function, and muscle mass. Wochner et al(9). A randomized controlled trial was employed to examine the impact of progressive resistance training on interventions in patients with PC, demonstrating similar enhancements in physical function and quality of survival. Luo et al(10). implemented an intervention combining aerobic and resistance training in PC patients, excluding those with a postoperative period of less than three months. This approach led to improvements in physical function, quality of survival, and sleep quality, as well as reductions in fatigue and depression, and mitigated the decline in debilitation and fatigue. A study by Ngo A et al(11). investigated home-based exercise for PC patients, which also resulted in improved quality of survival and physical functioning. However, current research predominantly focuses on non-surgical patients, preoperative rehabilitation for surgical patients, and outcomes of home exercise rehabilitation, with limited studies addressing the effects of perioperative exercise rehabilitation. With the rapid advancement of clinical medical technology, minimally invasive surgery is increasingly becoming a prevalent trend. In comparison to traditional laparoscopic surgery, the da Vinci robotic-assisted approach offers several advantages, including reduced intraoperative bleeding, more comprehensive lymph node dissection, a lower incidence of intermediate openings, and a shorter duration of postoperative hospitalization. These benefits collectively contribute to delaying muscle loss and enhancing patient prognosis(12). According to the Accelerated Rehabilitation Surgery Clinical Practice Guidelines(13), initiating resistance training for post-PC patients\u0026mdash;whether in bed, seated, or out of bed\u0026mdash;as soon as possible within 24 hours post-surgery is recommended. This early intervention facilitates functional recovery, decreases the length of postoperative hospitalization, shortens the time required to regain preoperative functional status, and ultimately improves the overall mean functional recovery following treatment. Consequently, it is imperative to implement exercise interventions for post-PC patients at the earliest opportunity, while ensuring patient safety.\u003c/p\u003e\n\u003cp\u003ePersonalized Exercise Prescription (PEP) refers to an exercise regimen specifically designed to meet the unique needs of an individual, encompassing six fundamental components: exercise frequency (F), exercise intensity (I), exercise time (T), exercise type (T), exercise volume (V), and exercise process (P)(14). For the majority of cancer patients, current guidelines advocate for a minimum of 150 minutes of moderate- to high-intensity aerobic exercise weekly, supplemented by resistance training on at least two days per week(15). Given that the general condition of post-PC patients treatment is often compromised, a more customized exercise prescription is advisable. This approach entails initiating exercise at a low intensity and progressively adjusting to a suitable level of intensity, adhering to the three foundational principles of exercise program design: individualization, gradual progression, and perseverance(16). Furthermore, Ba Duan Jin, a traditional Chinese physical fitness practice, serves as both a moderate-intensity aerobic exercise and a comprehensive method that harmonizes the body, breath, and mind. Empirical studies have demonstrated that Baduanjin can significantly enhance patients\u0026apos; mood and sleep quality(17). Integrating Baduanjin into exercise prescriptions offers distinct advantages not typically found in conventional exercise regimens. Notably, Baduanjin movements are imbued with unique elements of Chinese medicine and qigong, which are readily embraced by patients, thereby enhancing their adherence to exercise routines.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIn summary, exercise interventions, as potential adjunctive therapies, have demonstrated positive impacts on physical function and quality of life among patients with PC. Nonetheless, there is a paucity of comprehensive research on the application of personalized exercise prescriptions for post-PC patients, particularly concerning the effects of exercise rehabilitation during the perioperative period. To address this research gap, we propose to conduct a randomized controlled trial to evaluate the impact of personalized exercise prescriptions on post-PC patients. Our primary hypothesis posits that personalized exercise prescriptions can ameliorate muscle loss, enhance physical function, and improve the quality of life in these patients. Secondly, we posited that the implementation of personalized exercise prescriptions would mitigate adverse symptoms such as cancer-related fatigue, cancer pain, anxiety, depression, and poor sleep quality in post-PC patients, thereby enhancing their overall quality of life. This study aims to contribute to the development of a more comprehensive and individualized treatment plan for the rehabilitation of post-PC patients.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003e\u003cstrong\u003eStudy design\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA randomized controlled clinical trial will be conducted at Guizhou Medical University Hospital. Participants will include patients with pathologically confirmed pancreatic cancer who have undergone da Vinci robotic-assisted surgery. These patients will be randomly assigned to either a control group or an experimental group in a 2:1 ratio. The experimental group will receive a 4-week personalized exercise prescription intervention postoperatively, followed by a 12-week follow-up period. In contrast, the control group will receive standard treatment, which includes routine care and early postoperative activities. The flowchart outlining the entire trial is depicted in Figure 1, and the timeline is presented in Figure 2. The study protocol was developed in accordance with the SPIRIT 2013 guidelines(18).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSample size estimation\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe post-intervention skeletal muscle index was utilized as the primary outcome measure. A differential unequal design (k = 1:2) was employed to allocate participants into the usual care group and the exercise prescription intervention group. Based on data from the literature(8), the intervention was scheduled for a duration of 16 weeks. The expected difference in mean skeletal muscle index between the intervention and control groups was 1.2, with a standard deviation of 3.2. Given these parameters, and assuming a Type I error rate (α) of 0.05 and a statistical power (1 - β) of 80%, while accounting for a 10% dropout rate, a total sample size of 168 participants was determined to be necessary. This included 112 participants in the control group and 56 participants in the experimental group. Sample size calculations were conducted using G-Power software.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRecruitment and informed consent\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eParticipants for the randomized controlled trial (RCT) were recruited from September 2025 to September 2027 at the Affiliated Hospital of GuiZhou Medical University. Recruitment efforts utilized both digital and traditional methods, including social media platforms and offline advertisements such as posters and health promotion brochures. Eligible patients were included in the study. All participants received the intervention plan and were informed of the study's potential benefits and risks. Prior to randomization, all participants provided written informed consent. The study received ethical approval from the Ethics Committee of Guizhou Medical University Hospital (approval number: 2024-507).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRecruitment and informed consent\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eParticipants will be eligible for recruitment if they satisfy the following criteria:\u003c/p\u003e\n\u003cp\u003e(1) they are 18 years of age or older;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e(2) they have a confirmed diagnosis of pancreatic cancer based on pathological examination;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e(3) they are scheduled to undergo either da Vinci robot-assisted radical surgery or partial resection;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e(4) they provide written informed consent.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eExclusion criteria\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eParticipants will be excluded from the study if they meet any of the following criteria:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e(1) Presence of combined severe organ failure or compromised cardiopulmonary function that precludes the ability to tolerate the training;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e(2) Diagnosis of extensive tumor metastasis for which only palliative surgery is indicated;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e(3) Coexisting psychiatric illness, speech disorder, or communication difficulties.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRandomisation and allocation concealment\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA total of 168 eligible patients will be assigned to either the trial or control groups in a 1:2 ratio. Randomization sequences will be generated using Stata software version 17.0. The allocation process will be conducted by a member of the research team who is not involved in the intervention or data collection but possesses statistical expertise. The randomization codes will be concealed within opaque envelopes to ensure that neither the participants nor the intervention implementers are aware of the group assignments until the randomization process is finalized.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eBlinding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study is structured as a single-blind trial, wherein participants remain unaware of their group assignments throughout the study. Personnel responsible for recruitment, intervention administration, data collection, statistical analysis, and data management will function independently. Additionally, data collectors and statistical analysts will remain blinded to group assignments during both the collection of outcome indicators and the data analysis. All samples and data will be anonymized prior to data collection and statistical analysis.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eIntervention\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ea.Formation of multidisciplinary teams\u003c/p\u003e\n\u003cp\u003eAssemble a multidisciplinary team comprising exercise prescribers, clinicians, clinical nurses, rehabilitation therapists, and physiotherapists. This team collaboratively developed a personalized exercise prescription program and facilitated the implementation of the intervention. Clinicians were tasked with evaluating the participants' disease status, overall health, and postoperative recovery. Exercise prescribers ensured the program's feasibility, scientific rigor, and standardization. Clinical nurses participated in the intervention's execution and data collection. Rehabilitation therapists and physiotherapists provided guidance on movement training to the patients.\u003c/p\u003e\n\u003cp\u003eb. Personalized Exercise Prescription\u003c/p\u003e\n\u003cp\u003eThis study is scheduled to be conducted in the second ward of the Hepatobiliary Surgery Department at the Affiliated Hospital of Guizhou Medical University, with a 16-week exercise prescription intervention planned. Participants will engage in exercise interventions for approximately 45 to 60 minutes, three to five times per week. These sessions will encompass warm-up activities, aerobic exercises, resistance training, stretching exercises, and relaxation techniques. Prior to commencing the intervention, participants will undergo two instructional sessions designed to familiarize them with assessing exercise intensity using the Borg Scale of Perceived Exertion (PRE). Additionally, participants will complete a one-repetition maximum (1-RM) test, with each comprehensive training session lasting approximately 60 minutes. A baseline assessment of participants will be conducted preoperatively, and outcome measures will be collected at enrollment (T0), four weeks postoperatively (T1), and at a 12-week follow-up (T2) to evaluate the efficacy of the exercise intervention.\u003c/p\u003e\n\u003cp\u003eThe personalized exercise regimen is structured into four distinct phases: the bed exercise phase, the sitting exercise phase, the standing exercise phase, and the follow-up home exercise phase. During their hospital stay, participants will receive full supervision, while partial supervision will be provided during the follow-up period. The intervention is implemented through a tailored exercise prescription that includes specific guidelines. The intervention was implementedvia a tailored exercise prescription, encompassing comprehensive and specific guidelines regarding the type, frequency, duration, and intensity of the exercises.These details were meticulously documented in an exercise logbook. Each participant was supplied with elastic bands, and daily follow-up telephone consultations were conducted to monitor progress, address emerging issues, and instruc patients on techniques for self-monitoring exercise intensity.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 1\u003c/strong\u003e Exercise prescription\u003c/p\u003e\n \u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"604\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\"\u003e\n \u003cp\u003e\u003cstrong\u003eIntervention phase\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"6\"\u003e\n \u003cp\u003e\u003cstrong\u003eDetails of intervention\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eExercise assessment\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eFrequency\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eIntensity\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eTime\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eType\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eContent of the campaign\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"4\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eBed exercise phase\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"4\" valign=\"top\"\u003e\n \u003cp\u003eThe patient was unable to move independently from a prone to a sitting position after surgery, but active or passive movement of the extremities was possible\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e2~3 times a week\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e5~10min\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eWarm-up\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eShoulder rotation, elbow flexion, wrist rotation, knee flexion and ankle rotation\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e3~5 times a week\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e5～10 times/set.\u003c/p\u003e\n \u003cp\u003e5～10 sets\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e15~20min\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eRespiratory exercises\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eRespiratory muscle strength and endurance exercises using assisted breathing trainers or abdominal breathing\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e2~3 times a week\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eEach movement 8~12 times/set, 2~3 sets\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e15~20min\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eResistance movement\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eFist movements, arm lifts, straight leg raises, prone knee flexion and ankle plantarflexion and dorsiflexion movements\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e2~3 times a week\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e5~10min\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eStretching activities\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eMuscle massage relaxation mainly focusing on patient's muscle relaxation\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"5\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eSeated movement phase\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"5\" valign=\"top\"\u003e\n \u003cp\u003eThe patient was able to change positions independently (prone to sitting) and to sit at the bedside for 20 min after surgery, but was unable to perform independent ambulation.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e2~3 times a week\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e5~10min\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eWarm-up\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eSame-lying position exercise content\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e2~3 times a week\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eSingle-leg stand for 15s, 3 to 5 reps; 3 to 5 sets of dynamic training movements\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e15~20min\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eBalance training\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eStatic balance training (one-legged standing) and dynamic balance training (assisting the patient in cross walking, parallel walking and semi-tandem walking)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e3~5 times a week\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e5～10 times/set.\u003c/p\u003e\n \u003cp\u003e5～10 sets\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e15~20min\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eRespiratory exercises\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eSame-lying position exercise content\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e2~3 times a week\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e1~2 sets of 20 repetitions (50-60% 1-RM)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e15~20min\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eResistance movement\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eExercise content adds bridge exercises, grip strength training and elastic band training to the content of the previous phase.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e2~3 times a week\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eHold the stretched position for at least 20 seconds, with 20-25 second intervals between each session\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e5~10min\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eStretching activities\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003ePerform some of the seated poses of your yoga training for stretching, such as\u003csup\u003e1\u003c/sup\u003e.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"4\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eStanding position exercise phase\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"4\" valign=\"top\"\u003e\n \u003cp\u003eThe patient can independently get out of bed and walk without uprightness intolerance in standing and walking.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e2~3 times a week\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e5~10min\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eWarm-up\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003ePerform large joint activities in various parts of the body\u003csup\u003e2\u003c/sup\u003e.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e2~3 times a week\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eBorg score (7 to 12) on the Perceptual-Recognitive Exercise Scale (PRE)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e10-20min，increase gradually\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eAerobic exercise\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eWalking and Ba Duan Jin\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e1~2 times a week\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e1~2 sets of 20 repetitions, (50-60% 1-RM)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e25~30min\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eResistance movement\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eChoose from 2 to 3 movements per workout\u003csup\u003e3\u003c/sup\u003e.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e2~3 times a week\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eHold the stretched position for at least 20 seconds, with 20-25 second intervals between each session\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e10~15min\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eStretching exercise\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eThe main part of the yoga training is to stretch\u0026nbsp;\u003csup\u003e4\u003c/sup\u003e.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eHome follow-up phase\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"6\" valign=\"top\"\u003e\n \u003cp\u003eThe content of the exercise prescription was the same as above, gradually increasing the number of movements and groups of movements according to the patient's own tolerance ability, and gradually increasing the intensity of the exercise by 5% after 3 sets of 12 repetitions could be completed for 3 consecutive times. Supervision was performed using the Borg score (10-13 points) of the Perceived Exercise Rating Scale (PRE).\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n\u003c/div\u003e\n\u003cp\u003e(NOTE: 1.Perform a gentle lateral flexion of the torso while seated, ensuring to elongate the lateral musculature of the body. Additionally, execute a seated stretch against the wall to effectively target and extend the anterior deltoid and pectoral muscles. 2.The movements include adduction, flexion, and extension of the neck; rotation of the neck and shoulders; flexion of the elbows; rotation of the wrists; flexion and adduction of the hips; flexion of the knees; and rotation of the ankles. 3.Resistance exercises encompass the training of eight primary upper and lower body muscle groups. These exercises include movements such as front arm raises, lateral arm raises, arm curls, overhead presses, chest presses, wall push-ups, squats, and alternating leg lifts performed in both seated and supine positions, utilizing equipment such as dumbbells or elastic bands. 4.Examples of fundamental movements include low lunges, which stretch the front of the hip; side stretches, which strengthen and stretch the back of the leg; easy sitting side stretches, which target the side of the body; one-legged slants, which stretch the calf and back of the ankle; standing on one leg, which stretches the front of the thigh; half pigeon poses, which stretch the outside of the hip; standing against the wall, which stretches the front of the shoulder and chest muscles; bull arm poses, which stretch the front of the shoulder and armpit; and supine twists, which facilitate spinal stretching.)\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eOutcomes\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ea. Primary outcome\u003c/p\u003e\n\u003cp\u003e1. Muscle Mass\u003c/p\u003e\n\u003cp\u003eThe assessment of skeletal muscle mass, including the skeletal muscle index (SMI) and skeletal muscle density (SMD), was conducted utilizing computed tomography (CT) scans. Specifically, CT images were obtained from the midpoint of the third lumbar vertebra (L3) for analysis. These images were quantified using SliceOmatic software (version 5.0, rev-4a2, TomoVision), applying established pixel-density thresholds in Hounsfield units (HUs) to calculate the skeletal muscle cross-sectional area (CSA in cm²), thereby facilitating the evaluation of the patient's muscle mass.\u003c/p\u003e\n\u003cp\u003e2. Physical Function\u003c/p\u003e\n\u003cp\u003eThe patient's physical function was evaluated using the 6-Minute Walk Test (6MWT), a standardized measure for assessing exercise tolerance and gait balance. The 6MWT should be administered indoors within a long, flat, straight, and enclosed corridor. The corridor should ideally be 30 meters in length, with markings placed every 3 meters from the starting point. The start and end points must be distinctly marked with brightly colored tape. Prior to conducting the test, the examiner should be equipped with a stopwatch and essential first aid equipment, such as a first aid kit or an automated external defibrillator. The patient is advised to wear comfortable attire and properly fitting footwear, and to abstain from engaging in strenuous activities for a minimum of two hours prior to the test. If necessary, patients should utilize their usual walking aids, such as crutches, during the test. Baseline measurements of the patient's blood pressure and heart rate should be obtained before the test. At the onset of the test, the patient should position themselves at the starting line, with the timer set for a 6-minute countdown. If required, the procedure should be demonstrated to the patient, and the test should commence once the patient confirms their readiness. During the administration of the 6-minute walk test, it is important not to accompany the patient. Upon completion of the test, the distance covered by the patient should be documented, rounding to the nearest meter. The test should be immediately discontinued if the patient exhibits any of the following symptoms: chest pain, intolerable dyspnea, cramps in the lower limbs, staggering, or pallor. It is essential to recognize the absolute contraindications for the 6-minute walk test, which include unstable angina or myocardial infarction within the preceding month. Relative contraindications include a resting heart rate exceeding 120 beats per minute, a systolic blood pressure greater than 180 mm Hg, and a diastolic blood pressure exceeding 100 mm Hg. The test should not be administered if the patient exhibits any of these contraindications.\u003c/p\u003e\n\u003cp\u003e3. Quality of Life\u003c/p\u003e\n\u003cp\u003eQuality of survival was assessed using the Quality of Life Core Questionnaire (EORTC QLQ-C30), a pivotal tool developed by the European Organisation for Research and Treatment of Cancer (EORTC) to evaluate the quality of life in cancer patients. In this study, the Chinese version of the EORTC QLQ-C30 was utilized(19). This instrument consists of 30 items across 15 domains, including five functional domains and one domain assessing overall health status, where higher scores indicate better functioning. It also includes three symptom domains and six single-item measures, with higher scores reflecting more severe symptoms.\u003c/p\u003e\n\u003cp\u003eb. Secondary outcomes\u003c/p\u003e\n\u003cp\u003e1. Anxiety and Depression\u003c/p\u003e\n\u003cp\u003eThe study utilized the Hospital Anxiety and Depression Scale (HADS)(20) to evaluate symptoms of anxiety and depression. This instrument is specifically designed for screening purposes and comprises two subscales, each containing seven items. Each item is rated on a scale from 0 to 3, resulting in a total score range of 0 to 21. Scores above 7 indicate the presence of anxiety or depression symptoms, with higher scores signifying greater symptom severity.\u003c/p\u003e\n\u003cp\u003e2. Cancer-related fatigue\u003c/p\u003e\n\u003cp\u003eTo assess cancer-related fatigue, the Chinese version of the Functional Assessment of Cancer Therapy-Fatigue Scale (FACT-F)(21) was employed. This scale consists of 41 items, yielding a total score range of 0 to 164, and is divided into six dimensions: physiological well-being (7 items), social/family well-being (7 items), emotional well-being (5 items), functional well-being (7 items), fatigue (13 items), and relationship with the physician (2 items).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e3. Sleep quality\u003c/p\u003e\n\u003cp\u003ethe Pittsburgh Sleep Quality Index (PSQI)(22) was used to evaluate patients' sleep quality. The Pittsburgh Sleep Quality Index (PSQI) consists of 19 self-reported items and 5 observer-reported items, which are organized into seven dimensions: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each dimension is evaluated on a scale from 0 to 3, and the sum of these scores forms the total PSQI score, which ranges from 0 to 21, with higher scores indicating poorer sleep quality.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ec.\u0026nbsp;\u003c/strong\u003eSafety outcomes\u003c/p\u003e\n\u003cp\u003eAt the end of each 4-week treatment period, pertinent adverse events will be recorded, including severe pain, pancreatic fistula, falls, syncope, palpitations, and exacerbations. All adverse events occurring during the study will be addressed appropriately. In the event of a serious adverse event, researchers will recommend that patients seek medical attention if they experience persistent discomfort.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStatistical analysis\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe trial data will be managed by a designated member of the data management team. Initially, the collected data will be entered into Excel to create a database, which will then be imported into SPSS version 29.0 for statistical analysis. All analyses will employ two-sided tests with a significance level set at α = 0.05. An intent-to-treat (ITT) approach will be adopted to evaluate all outcome indicators, with the analysis set including all participants. Missing data will be addressed using the last observation carried forward method for interpolation. Outcome indicators measured as continuous data that conform to a normal distribution will be reported using means and standard deviations, while those not conforming to a normal distribution will be described using medians and interquartile ranges. Categorical variables will be presented as frequencies and percentages. Comparative analyses between the intervention and control groups will be performed to assess differences in baseline socio-demographic characteristics, comorbidities, and tumor stage, utilizing t-tests for continuous variables, chi-square tests for categorical variables, and Fisher's exact tests when appropriate. For the purpose of between-group comparisons at each measurement point within the intervention and control groups, the normality of the data was evaluated using the Shapiro-Wilk test. In instances where the data adhered to a normal distribution, a t-test was utilized to compare the means of two independent samples. Conversely, when the data deviated from a normal distribution, a rank-sum test was employed for comparison. Longitudinal changes in the relevant variables within each group across time points T0, T1, and T2 were analyzed using repeated measures ANOVA. Pairwise comparisons at each measurement point were conducted using the Student-Newman-Keuls (S-N-K) test. Effect size (ES) was calculated to quantify the extent to which the time factor contributed to the variation in each measure within the intervention and control groups. The repeated measures ANOVA revealed an interaction between time and group, necessitating further analysis of the effect of grouping on each measure using analysis of covariance (ANCOVA), with 'grouping' as a fixed factor and 'time' as a covariate.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003ePancreatic cancer, a malignancy of the digestive system, is characterized by a poor prognosis, primarily due to its low rate of early detection and high degree of malignancy. The depletion of muscle and adipose tissue in cancer patients significantly influences surgical complications and the long-term prognosis of individuals with pancreatic cancer. A meta-analysis indicates that 41.0% of pancreatic cancer patients develop sarcopenia(\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e), which can extend hospitalization duration, elevate the risk of complications(\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e), and may progress to a more severe malignant condition(\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e). This condition results in reduced muscle mass, diminished physical function, and a lower quality of life for patients with pancreatic cancer. Recent studies have demonstrated that exercise interventions positively affect the prognosis of pancreatic cancer patients(\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e), by decreasing the incidence of postoperative complications and enhancing cardiopulmonary function and muscle strength. Consequently, these interventions facilitate the recovery of patients' physical function and improve their overall quality of life. Nevertheless, the exercise intervention protocols employed in previous studies exhibit certain limitations: they lack personalization, predominantly emphasize resistance exercise, and are presented in a uniform format, potentially resulting in suboptimal patient adherence. To address these issues, we developed a tailored exercise regimen specifically for postoperative pancreatic cancer patients. This regimen integrates aerobic exercise with resistance training, incorporating the traditional Chinese exercise Ba Duan Jin, thereby diversifying the exercise modalities available to patients. To ensure appropriate exercise intensity, patients were instructed to utilize the Borg scale for fatigue assessment and were provided with heart rate monitors to maintain their exercise within the target heart rate zone.\u003c/p\u003e \u003cp\u003eThis study is subject to several limitations. Firstly, the personalized nature of the intervention program precluded the possibility of blinding both the implementers and the participants. Secondly, the findings may be subject to potentialbiases arising from the limited sample size and the single-center study design.\u003c/p\u003e \u003cp\u003eNonetheless, this research aims to develop a novel personalized exercise prescription intended to enhance muscle mass, physical function, and quality of life in patients recovering from pancreatic cancer surgery, thereby offering new insights for clinical practice.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAuthor Contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eConceptualization and design: Mengjiao Liu. Recruitment: Mengjiao Liu. Investigating Mengjiao Liu. Project Administration: Sara LK Low. Writing- original draft: Mengjiao Liu. Writing-review and editing: Mengjiao Liu. All authors read and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of Data and Materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for Publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eConsent for publication is not required as there is no details on individuals reported within the manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDeclaration of Conflicting Interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This paper is part of a Master's study and it is supported by Guizhou Medical University School of Nursing, Affiliated Hospital of Guizhou Medical University[Grant Numbers: gyfyhlxz-2024-5].\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial Status\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eRecruitment of participants started on September 2025. The trial is currently underway and expected to be completed by end of 2027.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics Approval and Consent to Participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study has been approved by The Ethics Committee of the Affiliated Hospital of GuiZhou Medical University (NO: 2024-507). All methods will be conducted in accordance with the ethical standards of the declaration of Helsinki. Informed consent will be obtained from all subjects.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSupplemental Material\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eSupplemental material for this article is available online.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eHalbrook CJ, Lyssiotis CA, Pasca di Magliano M, Maitra A. Pancreatic cancer: Advances and challenges. Cell. 2023;186(8):1729-54.\u003c/li\u003e\n\u003cli\u003eBray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-63.\u003c/li\u003e\n\u003cli\u003eGuishan X. Expert consensus on the molecular diagnosis of early-stage pancreatic cancer(2023 edition). JOURNAL OF CLINICAL HEPATOLOGY. 2024;40(3):473-7.\u003c/li\u003e\n\u003cli\u003eSiegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA Cancer J Clin. 2024;74(1):12-49.\u003c/li\u003e\n\u003cli\u003eNetwork NCC. NCCN clinical practice guidelines in oncology (NCCN Guidelines\u0026reg;) Pancreatic Adenocarcinoma 2. 2024.\u003c/li\u003e\n\u003cli\u003eXinsheng L, Limin Z, Shunxiang W, Ningning F. Value of skeletal muscle index combined with interleukin-6 and activin A in predicting early-stage pancreatic cancer cachexia. JOURNAL OF CLINICAL HEPATOLOGY. 2024;40(6):1226-30.\u003c/li\u003e\n\u003cli\u003eGualtieri P, Cianci R, Frank G, Pizzocaro E, De Santis GL, Giannattasio S, et al. Pancreatic Ductal Adenocarcinoma and Nutrition: Exploring the Role of Diet and Gut Health. Nutrients. 2023;15(20).\u003c/li\u003e\n\u003cli\u003eNemkov T, Cendali F, Dzieciatkowska M, Stephenson D, Hansen KC, Jankowski CM, et al. A Multiomics Assessment of Preoperative Exercise in Pancreatic Cancer Survivors Receiving Neoadjuvant Therapy: A Case Series. Pathophysiology. 2024;31(1):166-82.\u003c/li\u003e\n\u003cli\u003eWochner R, Clauss D, Nattenmuller J, Tjaden C, Bruckner T, Kauczor HU, et al. Impact of progressive resistance training on CT quantified muscle and adipose tissue compartments in pancreatic cancer patients. PLoS One. 2020;15(11):e0242785.\u003c/li\u003e\n\u003cli\u003eLuo H, Galvao DA, Newton RU, Tang CI, Hart NH, Singh F, et al. Evaluation of a Clinic-Based Exercise Program in Patients with Pancreatic Cancer Undergoing Nonsurgical Treatment. Med Sci Sports Exerc. 2023;55(1):9-19.\u003c/li\u003e\n\u003cli\u003eNgo-Huang A, Parker NH, Bruera E, Lee RE, Simpson R, O\u0026apos;Connor DP, et al. Home-Based Exercise Prehabilitation During Preoperative Treatment for Pancreatic Cancer Is Associated With Improvement in Physical Function and Quality of Life. Integr Cancer Ther. 2019;18:1534735419894061.\u003c/li\u003e\n\u003cli\u003eGuangping T, Jichun S, Wanpin N, Gui H, Xiao Y. Comparison of efficacy and safety of robotic-assisted versus laparoscopic pancreaticoduodenectomy for pancreatic cancer. Chinese Joumal of General Surgery. 2020;29(3):268-75.\u003c/li\u003e\n\u003cli\u003eChen C, Lai W. Hunan expert consensus on clinical pathway for enhanced recovery after surgery of hepatopancreatobiliary surgical diseases(2022 version). Chinese Joumal of General Surgery. 2022;31(7):847-59.\u003c/li\u003e\n\u003cli\u003eLi Y, Zhang D, Fu S, Liu M, Liu H. Design and application of personalized exercise prescription for primary osteoporosis. Medicine (Baltimore). 2023;102(7):e32857.\u003c/li\u003e\n\u003cli\u003eRock CL, Thomson CA, Sullivan KR, Howe CL, Kushi LH, Caan BJ, et al. American Cancer Society nutrition and physical activity guideline for cancer survivors. CA Cancer J Clin. 2022;72(3):230-62.\u003c/li\u003e\n\u003cli\u003eMedicine CAoR. Expert Consensus on Exercise Rehabilitation for Chinese Cancer Patients Focusing on Functional Dysfunction. CHINESE JOURNAL OF REHABILITATION MEDICINE. 2023;38(1):1-7.\u003c/li\u003e\n\u003cli\u003eQian Z, Yan L, Yuxue L. Effects of Baduanjin exercise on depression, sleep quality and life quality of patients with breast cancer in the rehabilitation perioddepression, sleep quality and life quality of patients with breast cancer in the rehabilitation period. Chin J Sports Med. 2024;43(6):458-64.\u003c/li\u003e\n\u003cli\u003eChan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200-7.\u003c/li\u003e\n\u003cli\u003eChonghua W, Mingqing C, Chanzhen Z, Xueliang T, Qiong M, Xiaoxing Z. Quality of Life Scale for Cancer Patients EORTC Review of the Chinese version of QLQ-C30. Journal of Practical Oncology. 2005(4):353-5.\u003c/li\u003e\n\u003cli\u003eZhenxiao S, Huaxue L, Linyin J, Tao Z, Luoning Y, Jinyun F. A study of the reliability and validity of the Hospital Anxiety and Depression Scale. Chinese Journal of Clinicians(Electronic Edition). 2017;11(2).\u003c/li\u003e\n\u003cli\u003eChang G, Cuicui Z, Tong X, Ning L. Reliability analysis of the Chinese version of the Fatigue Scale for Functional Assessment of Cancer Therapy in oncology patients. Chinese General Practice. 2016;19(21):2596-600.\u003c/li\u003e\n\u003cli\u003eBuysse DJ, Reynolds CF, 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989;28(2):193-213.\u003c/li\u003e\n\u003cli\u003eSurov A, Wienke A. Prevalence of sarcopenia in patients with solid tumors: A meta-analysis based on 81,814 patients. JPEN J Parenter Enteral Nutr. 2022;46(8):1761-8.\u003c/li\u003e\n\u003cli\u003eTsukagoshi M, Araki K, Shirabe K. Pancreatic cancer and sarcopenia: a narrative review of the current status. Int J Clin Oncol. 2024;29(8):1055-66.\u003c/li\u003e\n\u003cli\u003eSakamoto T, Kishino M, Murakami Y, Miyatani K, Hanaki T, Shishido Y, et al. The cachexia index is a prognostic factor for patients with recurrent pancreatic cancer. Surg Today. 2024;54(12):1498-504.\u003c/li\u003e\n\u003cli\u003eFengjian Z, Cheng C, Ning Z, Heshui W, Bei Z, Xing Z, et al. Exercise interventions for pancreatic cancer patients: a scoping review. JOURNAL OF NURSING SCIENCE. 2023;38(20):116-21.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":true,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Pancreatic cancer, Da Vinci robot, Robotic surgery, Exercise prescription, aerobic exercise, Resistance exercise, Physical rehabilitation, Quality of life","lastPublishedDoi":"10.21203/rs.3.rs-6252683/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6252683/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground: \u003c/strong\u003ePancreatic cancer is characterized by a 5-year survival rate of less than 12%, primarily because of challenges in early diagnosis, which has resulted in a generally poor prognosis for patients. With ongoing advancements in diagnostic and surgical technologies, there is an increasing focus on enhancing the postoperative quality of life for individuals with pancreatic cancer. Although existing research suggests that exercise interventions are safe for this patient population, definitive evidence regarding their efficacy remains insufficient. Consequently, this study aims to conduct a randomized controlled trial to assess the safety and efficacy of exercise interventions in enhancing muscle mass, physical function, and quality of life among patients who have undergone surgery for pancreatic cancer.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods: \u003c/strong\u003eA total of 168 eligible postoperative pancreatic cancer patients will be enrolled and randomly allocated in a 1:2 ratio to either the intervention group or the control group. Participants in the intervention group will receive a personalized exercise prescription for a duration of 16 weeks, whereas participants in the control group will not receive any specific exercise prescription or intervention. The primary outcomes of this study include changes in muscle mass, specifically the skeletal muscle index and density, from baseline to week 16, as well as assessments of physical function using the 6-Minute Walk Test (6MWT) and evaluations of quality of life through standardized scale scores. Secondary outcomes comprise assessments using the Functional Assessment of Cancer Therapy Fatigue Scale (FACT-F), the Hospital Anxiety and Depression Scale (HADS), and the Pittsburgh Sleep Quality Index (PSQI). Measurements of outcome indicators other than muscle mass will be conducted at weeks 0, 4, and 12, respectively.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDiscussion:\u003c/strong\u003e The impact of the personalized exercise prescription intervention will be evaluated through alterations in primary and secondary outcome indicators at both the 4-week intervention mark and the 12-week follow-up period. This trial aims to offer novel clinical insights into the efficacy of personalized exercise prescriptions in enhancing muscle mass, physical function, and quality of life among postoperative pancreatic cancer patients.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial registration:\u003c/strong\u003e Clinical Trial Registry-China ChiCTR2500098709. Registered on 12 March 2025.\u003c/p\u003e","manuscriptTitle":"Impact of Personlized Exercise Prescription on Muscle Mass, Physical Function, and Quality of Life in Postoperative Pancreatic Cancer Patients Undergoing da Vinci Robotic Surgery: A Randomized Controlled Trial Protocol","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-05-07 07:23:46","doi":"10.21203/rs.3.rs-6252683/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"reviewerAgreed","content":"","date":"2025-04-30T03:03:56+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-04-29T13:18:02+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"Trials","date":"2025-04-29T11:26:06+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-03-25T06:32:36+00:00","index":"","fulltext":""},{"type":"submitted","content":"Trials","date":"2025-03-24T07:56:26+00:00","index":"","fulltext":""},{"type":"decision","content":"Minor revision","date":"2025-03-24T03:29:07+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"3fe51b3b-89ab-4544-add3-97ee0352c272","owner":[],"postedDate":"May 7th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2025-10-20T16:09:55+00:00","versionOfRecord":{"articleIdentity":"rs-6252683","link":"https://doi.org/10.1186/s13063-025-09078-0","journal":{"identity":"trials","isVorOnly":false,"title":"Trials"},"publishedOn":"2025-10-16 15:58:20","publishedOnDateReadable":"October 16th, 2025"},"versionCreatedAt":"2025-05-07 07:23:46","video":"","vorDoi":"10.1186/s13063-025-09078-0","vorDoiUrl":"https://doi.org/10.1186/s13063-025-09078-0","workflowStages":[]},"version":"v1","identity":"rs-6252683","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6252683","identity":"rs-6252683","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}