Full text
49,010 characters
· extracted from
preprint-html
· click to expand
Yoga Effect on Quality-of-Life Study Among Patients with Idiopathic Pulmonary Fibrosis (YES-IPF) | medRxiv /* */ /* */ <!-- <!-- /*! * yepnope1.5.4 * (c) WTFPL, GPLv2 */ (function(a,b,c){function d(a){return"[object Function]"==o.call(a)}function e(a){return"string"==typeof a}function f(){}function g(a){return!a||"loaded"==a||"complete"==a||"uninitialized"==a}function h(){var a=p.shift();q=1,a?a.t?m(function(){("c"==a.t?B.injectCss:B.injectJs)(a.s,0,a.a,a.x,a.e,1)},0):(a(),h()):q=0}function i(a,c,d,e,f,i,j){function k(b){if(!o&&g(l.readyState)&&(u.r=o=1,!q&&h(),l.onload=l.onreadystatechange=null,b)){"img"!=a&&m(function(){t.removeChild(l)},50);for(var d in y[c])y[c].hasOwnProperty(d)&&y[c][d].onload()}}var j=j||B.errorTimeout,l=b.createElement(a),o=0,r=0,u={t:d,s:c,e:f,a:i,x:j};1===y[c]&&(r=1,y[c]=[]),"object"==a?l.data=c:(l.src=c,l.type=a),l.width=l.height="0",l.onerror=l.onload=l.onreadystatechange=function(){k.call(this,r)},p.splice(e,0,u),"img"!=a&&(r||2===y[c]?(t.insertBefore(l,s?null:n),m(k,j)):y[c].push(l))}function j(a,b,c,d,f){return q=0,b=b||"j",e(a)?i("c"==b?v:u,a,b,this.i++,c,d,f):(p.splice(this.i++,0,a),1==p.length&&h()),this}function k(){var a=B;return a.loader={load:j,i:0},a}var l=b.documentElement,m=a.setTimeout,n=b.getElementsByTagName("script")[0],o={}.toString,p=[],q=0,r="MozAppearance"in l.style,s=r&&!!b.createRange().compareNode,t=s?l:n.parentNode,l=a.opera&&"[object Opera]"==o.call(a.opera),l=!!b.attachEvent&&!l,u=r?"object":l?"script":"img",v=l?"script":u,w=Array.isArray||function(a){return"[object Array]"==o.call(a)},x=[],y={},z={timeout:function(a,b){return b.length&&(a.timeout=b[0]),a}},A,B;B=function(a){function b(a){var a=a.split("!"),b=x.length,c=a.pop(),d=a.length,c={url:c,origUrl:c,prefixes:a},e,f,g;for(f=0;f<d;f++)g=a[f].split("="),(e=z[g.shift()])&&(c=e(c,g));for(f=0;f<b;f++)c=x[f](c);return c}function g(a,e,f,g,h){var i=b(a),j=i.autoCallback;i.url.split(".").pop().split("?").shift(),i.bypass||(e&&(e=d(e)?e:e[a]||e[g]||e[a.split("/").pop().split("?")[0]]),i.instead?i.instead(a,e,f,g,h):(y[i.url]?i.noexec=!0:y[i.url]=1,f.load(i.url,i.forceCSS||!i.forceJS&&"css"==i.url.split(".").pop().split("?").shift()?"c":c,i.noexec,i.attrs,i.timeout),(d(e)||d(j))&&f.load(function(){k(),e&&e(i.origUrl,h,g),j&&j(i.origUrl,h,g),y[i.url]=2})))}function h(a,b){function c(a,c){if(a){if(e(a))c||(j=function(){var a=[].slice.call(arguments);k.apply(this,a),l()}),g(a,j,b,0,h);else if(Object(a)===a)for(n in m=function(){var b=0,c;for(c in a)a.hasOwnProperty(c)&&b++;return b}(),a)a.hasOwnProperty(n)&&(!c&&!--m&&(d(j)?j=function(){var a=[].slice.call(arguments);k.apply(this,a),l()}:j[n]=function(a){return function(){var b=[].slice.call(arguments);a&&a.apply(this,b),l()}}(k[n])),g(a[n],j,b,n,h))}else!c&&l()}var h=!!a.test,i=a.load||a.both,j=a.callback||f,k=j,l=a.complete||f,m,n;c(h?a.yep:a.nope,!!i),i&&c(i)}var i,j,l=this.yepnope.loader;if(e(a))g(a,0,l,0);else if(w(a))for(i=0;i (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];var j=d.createElement(s);var dl=l!='dataLayer'?'&l='+l:'';j.src='//www.googletagmanager.com/gtm.js?id='+i+dl;j.type='text/javascript';j.async=true;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-P4HH5NV'); Skip to main content Home About Submit ALERTS / RSS Search for this keyword Advanced Search Yoga Effect on Quality-of-Life Study Among Patients with Idiopathic Pulmonary Fibrosis (YES-IPF) Suha Kadura , View ORCID Profile Soumik Purkayastha , Josh Benditt , Amit Anand , Bridget Collins , Miguele De Quadros , Mafara Hobson , MJ Biswas , Lawrence Ho , Cathie Spino , Ganesh Raghu doi: https://doi.org/10.1101/2025.05.20.25327762 Suha Kadura 1 Division of Pulmonary, Critical Care and Sleep Medicine, Center for Interstitial Lung Diseases, Department of Medicine, University of Washington , Seattle, WA, USA Find this author on Google Scholar Find this author on PubMed Search for this author on this site Soumik Purkayastha 2 Department of Biostatistics, University of Pittsburgh , Pittsburgh, PA, USA 6 Center for Health Equity Research and Promotion , Pittsburgh, PA, USA Find this author on Google Scholar Find this author on PubMed Search for this author on this site ORCID record for Soumik Purkayastha Josh Benditt 1 Division of Pulmonary, Critical Care and Sleep Medicine, Center for Interstitial Lung Diseases, Department of Medicine, University of Washington , Seattle, WA, USA Find this author on Google Scholar Find this author on PubMed Search for this author on this site Amit Anand 3 Division of Pulmonary, Critical Care and Sleep Medicine, Beth Israel Deaconess Medical Center , Boston, MA, USA Find this author on Google Scholar Find this author on PubMed Search for this author on this site Bridget Collins 1 Division of Pulmonary, Critical Care and Sleep Medicine, Center for Interstitial Lung Diseases, Department of Medicine, University of Washington , Seattle, WA, USA Find this author on Google Scholar Find this author on PubMed Search for this author on this site Miguele De Quadros 4 Independent certified yoga instructors Find this author on Google Scholar Find this author on PubMed Search for this author on this site Mafara Hobson 4 Independent certified yoga instructors Find this author on Google Scholar Find this author on PubMed Search for this author on this site MJ Biswas 4 Independent certified yoga instructors Find this author on Google Scholar Find this author on PubMed Search for this author on this site Lawrence Ho 1 Division of Pulmonary, Critical Care and Sleep Medicine, Center for Interstitial Lung Diseases, Department of Medicine, University of Washington , Seattle, WA, USA Find this author on Google Scholar Find this author on PubMed Search for this author on this site Cathie Spino 5 Department of Biostatistics, University of Michigan , Ann Arbor, MI, USA Find this author on Google Scholar Find this author on PubMed Search for this author on this site Ganesh Raghu 1 Division of Pulmonary, Critical Care and Sleep Medicine, Center for Interstitial Lung Diseases, Department of Medicine, University of Washington , Seattle, WA, USA Find this author on Google Scholar Find this author on PubMed Search for this author on this site For correspondence: graghu{at}uw.edu Abstract Full Text Info/History Metrics Supplementary material Data/Code Preview PDF ABSTRACT Rationale Patients with idiopathic pulmonary fibrosis have poor health-related quality of life. Objective Determine whether a modified yoga program in patients with idiopathic pulmonary fibrosis improves quality of life compared to usual care. Methods Randomized controlled, non-blinded, pilot clinical trial lasting 12 weeks with 2 arms involving 63 adults with idiopathic pulmonary fibrosis. The yoga program-arm consisted of interventions such as seated postures, breathing and meditation exercises designed by authors for idiopathic pulmonary fibrosis patients. The control arm continued with usual standard of care. Analysis of covariance was performed; no multiplicity adjustments were made on account of this being a pilot study. Measurements The primary outcomes were week-12 scores in seven patient-reported instruments, each with sub-domains, totaling 21 outcomes. Results 60 of the 63 participants (32 randomized to yoga; 31 receiving standard of care) completed the study (one death in each arm and one withdrawal in yoga group). Analysis of covariance for week-12 scores, adjusting for baseline scores and confounders, revealed significant treatment effects favoring yoga in the L-IPF cough domain (-9.29 points, 95% CI -18.37 to -0.20; p=0.045), in the L-IPF total score (-7.11, 95% CI -13.15 to -1.06; p=0.022), and in the R-scale-PF cough domain (-1.18, 95% CI - 2.27 to -0.10; p=0.034) in the study population. Conclusion Patients with idiopathic pulmonary fibrosis participating in a yoga program demonstrated significant improvement in quality of life assessed by the cough and total scores of L-IPF and the cough score of R-scale-PF than those receiving usual care. Summary We examine if the implementation of a modified yoga program improves patient-reported outcomes in patients with idiopathic pulmonary fibrosis. Our study reveals significant post-yoga improvements in the yoga group compared to the control group across different patient-reported outcomes. Such outcomes are meaningful endpoints in patients with idiopathic pulmonary fibrosis and serve as a critical endpoint in related clinical trials. 1. Introduction Idiopathic pulmonary fibrosis carries significant mortality and symptom burden, with limited therapeutic options. Despite the discovery of antifibrotic agents that slow the rate of decline of forced vital capacity, patients living with idiopathic pulmonary fibrosis suffer from persistent respiratory symptoms and diminished quality of life. There are no available pharmacologic therapies for idiopathic pulmonary fibrosis that have been shown to impact patient-reported outcomes, such as symptoms or health-related quality-of-life. Though biomarkers such as forced vital capacity or image patterns may identify effects of interventions on biological pathways of the disease process, they likely do not fully encompass treatment impact on how patients ‘feel, function, and survive,’ and only weakly correlate with patient-reported symptom measures 2 – 4 . Identification of treatment strategies for idiopathic pulmonary fibrosis with the aim of enhancing patients’ quality of life is a top priority. Yoga is a mind-body practice that has become an increasingly popular and effective method to treat and manage symptoms of chronic diseases, and is the most commonly used complementary health approach in the United States 5 . According to a 2017 national survey, about one in seven U.S. adults practiced yoga in the past 12 months, and the percentage of people practicing yoga grew from 2007 to 2017 6 . A mounting body of literature demonstrates the benefits of yoga not only in components of general wellness including stress, mental/emotional health, and sleep quality, but has also been shown to improve symptoms and quality of life in various chronic diseases including Chronic Obstructive Pulmonary Disease, asthma, cancer, heart failure, arthritis, and chronic pain 7 – 12 . Although classical yoga includes other elements, yoga as commonly practiced in the United States typically emphasizes standard components such as breathing exercises (pranayama), postures (asanas), and meditation (dhyana). Central to asanas and pranayama is diaphragmatic breathing, which may lead to improved chest expansion and decreased work of breathing. Studies evaluating the benefits of yoga in chronic respiratory diseases (largely asthma and Chronic Obstructive Pulmonary Disease) have shown improvement in variables such as forced expiratory volume in 1 second, tidal volume and minute ventilation, as well as increase in measures such as alveolar gas exchange and improved submaximal and maximal oxygen consumption, in addition to quality of life 13 – 16 . We sought to assess the effect of a standardized virtual, modified yoga program (henceforth, treatment) designed specifically for individuals with idiopathic pulmonary fibrosis at our center, with the effect on health-related quality of life as a primary objective. We hypothesized that a 12-week modified yoga program, designed specifically for individuals with idiopathic pulmonary fibrosis, would improve health- related quality of life compared to usual care. 2. Methods 2.1 Study design This study was a non-blinded, single center, randomized pilot trial conducted by the Center for Interstitial Lung Diseases at the University of Washington Medical Center. It was approved by the Institutional Review Board at the University of Washington and registered with ClinicalTrials.gov ( NCT02848625 ). See Sections 2 to 6 of Online Data Supplement for more details. 2.2 Participants Consenting adults with idiopathic pulmonary fibrosis meeting criteria established in 2018 by the American Thoracic Society, European Respiratory Society, Japanese Respiratory Society, and Latin American Thoracic Society at time of screening were eligible 17 . Exclusion criteria included comorbidities interfering with yoga (e.g., musculoskeletal discomfort), evaluation for lung transplant or hospice care, participation in yoga and/or pulmonary rehabilitation outside of the study at screening and during the study period. All patients were otherwise allowed to receive usual care for idiopathic pulmonary fibrosis including treatment with nintedanib or pirfenidone and supplemental oxygen when necessary, during the study period. 2.3 Randomization and masking Eligible participants were randomly allocated in a 1:1 ratio to either the treatment arm (following the modified yoga program), or the control arm (receiving standard of care and following usual activities) with stratification by supplemental oxygen need prior to enrollment to account for disease severity. The randomization schedule was prepared using computer-generated permuted random blocks of size 4 for each stratum. The sequence of allocation was hidden from the investigators to prevent selection bias. Participants, investigators, and providers were not blinded to intervention; see Figure E1 of the Online Data Supplement . 2.4 Procedures The modified yoga program consisted of seated postures, breathing, and meditation exercises designed by 5 certified yoga instructors tailored for fibrosis patients (see Table E1 and Section 9 of Online Data Supplement ). Chair yoga, as used in our study, is a gentler yoga alternative for older adults. Classical yoga with more strenuous movement that may involve poses on the floor, significant joint and muscle stretching was considered not to be appropriate for the typical idiopathic pulmonary fibrosis patient population. Chair yoga is quite popular and many studios and training courses for its practice are available, with prior studies demonstrating benefit in elderly patients 18 . The protocol was intended to be in-person, though was amended due to the COVID-19 pandemic to reduce exposure risk, with participants in the treatment arm participating in group sessions conducted virtually via Zoom in individuals’ homes (5-6 per group). Sessions lasted one hour, twice/week, for 12 consecutive weeks, led by a certified yoga instructor. The same instructor led each group’s sessions. Participants received a secure link to a pre-recorded demo video to practice during their free time. Participants in the treatment group received a journal at the beginning of the program and were encouraged to write in it at the end of each class ( see Section 8 of Online Data Supplement ). Journal entries were used in the qualitative assessment of the program. Attention control conditions were not implemented for the control group due to lack of feasibility and resource limitations during the pandemic. All patients were evaluated in person at baseline and after 12 weeks when lung function and 6-minute walk tests were performed, and patient-reported outcome measurements were collected. 2.5 Outcomes The primary outcomes measured were total/domain-specific scores from seven validated health-related quality of life tools collected at baseline and at the end of the 12-week study period. These included the Living with Idiopathic Pulmonary Fibrosis symptoms module (L-IPF symptoms), a recently developed and validated visual analog scale (VAS) for IPF called Raghu scale for pulmonary fibrosis (R-Scale-PF), King’s Brief Interstitial Lung Disease questionnaire (K-BILD), EuroQol-Five-Dimensional Five-Level questionnaire (EQ-5D-5L), Hospital Anxiety and Depression (HAD) Scale, Patient-Reported Outcomes Measurement Information System Sleep Disturbance and Sleep-Related Impairment (PROMIS SD and SRI), and Epworth Sleepiness Scale (ESS) 19 – 26 . Secondary outcomes included changes from baseline to 12 weeks in absolute and percent predicted forced vital capacity (FVC), diffusing capacity of the lungs for carbon monoxide (DLCO), and 6-minute walk distance (6MWD). 2.6 Questionnaires for Patient Reported Outcomes L-IPF questionnaire symptoms module The L-IPF symptoms module contains 15 items, with the total score derived as the average of the dyspnea (7 items), cough (5 items), and energy/fatigue (3 items) domains, each with a 24-hour recall period 19 . Each item is rated on a 5-point scale (0-4), with higher scores connoting greater impairment. The minimum clinically important difference estimates have been reported as 6 to 7 for the dyspnea domain score and 4 to 5 points for the cough domain score, though these estimates were investigated in a population of patients with progressive interstitial lung disease, other than idiopathic pulmonary fibrosis, which does not specifically apply to our study population 27 . R-scale-PF questionnaire The R-scale-PF is a visual analog scale assessing 5 domains (cough, shortness of breath, fatigue, depressed mood, and overall sense of well-being). Each domain score ranges from 0 to 10 with 0.5 increments. The total score ranges from 0 to 50 with lower numbers indicating better health-related quality of life 20 . A minimum clinically important difference estimate has not yet been defined in fibrosis patients. Details for the remaining utilized questionnaires are provided in Section 7 of Online Data Supplement. 2.7 Statistical analysis Study Design and Analysis Population This pilot trial utilized patient-reported outcomes as primary outcomes, with sample size determined by feasibility rather than power calculations, as well-defined data on clinically important differences were not available for the fibrosis population in the implemented instruments. The primary analysis set was the modified intention-to-treat population defined as all randomized participants with a week 12 visit Primary Analysis: Between-group comparisons for outcome scores were conducted using analysis of covariance (ANCOVA), adjusting for baseline questionnaire scores, age, sex, BMI, and supplementary oxygen use. Any of the outcomes that demonstrated significant improvement in the study population was considered a favorable outcome. All analyses were conducted in R (version 4.4.1). Given this is a pilot trial, p-values were not adjusted for multiple comparisons. Missing data were handled via multiple imputation with chained equations. Sensitivity analyses using complete cases were performed. 3. Results Between January 1-June 10, 2021, 63 consecutive, eligible patients provided consent. Thirty-two were randomly assigned to yoga and 31 to the control group. Thirty (94%) of 32 participants in the yoga group and 30 (97%) of 31 participants in the control group completed 12 weeks of assessment ( Figure 1 ) to form the study population. One participant from each study arm was missing at least one week 12 questionnaires. DLCO data were not available for one participant at baseline and four at week 12, one did not have week 12 FVC data, and two participants were missing 6MWD at baseline and 4 at week 12. Download figure Open in new tab Figure 1: CONSORT diagram. Baseline demographics are presented in Table 1 . Most participants were male (41 [68%] of 60), with mean age of 73.4 [SD 8.21] years. Median disease duration was 3.2 years. Most characteristics are comparable between the treatment groups, with no clinically meaningful differences. Participants had mild to moderate impairment in lung function at baseline (mean FVC% predicted was 74.8 [SD 21.44] and % predicted DLCO was 54.0 [18.27]). Twenty-two (37%) participants used supplemental oxygen. Fifty-one (85%) participants were on background antifibrotic therapy with either nintedanib or pirfenidone . Comorbid conditions included obstructive sleep apnea in 28 (47%) participants, emphysema in 5 (8%), gastroesophageal reflux disease (confirmed by pH probe) in 25 (42%), and pulmonary hypertension (confirmed by right heart catheterization) in 11 (18%). View this table: View inline View popup Table 1 Baseline characteristics of the study population. In Table 2 , adjusted comparisons between yoga and control groups for primary outcomes using multiple imputation are reported. For the L-IPF cough domain, the yoga group showed improvement from baseline score (mean 27.83 [SD = 25.69]) to week 12 (mean 18.10 [21.23]), while the control group remained stable (baseline: 24.83 [22.95]; week 12: 25.00 [22.09]). The imputation-based analysis showed a treatment effect that was statistically significant, favoring yoga (adjusted treatment effect: -9.29; 95% CI: [- 18.37, -0.20]; p=0.045). The yoga group showed improvement from baseline total L-IPF score (mean 30.84 [SD = 18.77]) to week 12 (mean 23.37 [16.49]), while the control group remained stable (baseline: 26.49 [19.60]; week 12: 27.16 [19.92]). The imputation-based analysis showed a treatment effect that was statistically significant, favoring yoga (adjusted treatment effect: -7.11; 95% CI: [-13.15, -1.06]; p=0.022). In the R-scale-PF cough domain, the yoga group demonstrated significant reduction in cough (baseline: 3.20 [SD 2.64]; week 12: 2.07 [2.31]), whereas the control group showed a slight worsening (baseline: 2.87 [2.21]; week 12: 3.14 [2.56]). The imputation-based analyses demonstrated significant treatment effects (-1.18; 95% CI: [-2.27, -0.10]; p=0.034). View this table: View inline View popup Table 2. Changes from baseline to week 12 and adjusted treatment effect of modified yoga program in primary outcomes for the study population. Figure 2 illustrates individual patient trajectories from baseline to week 12 across three pulmonary fibrosis outcome measures through a waterfall plot. Download figure Open in new tab Figure 2: Waterfall plot to illustrate individual patient changes from baseline to week 12 across three pulmonary fibrosis outcome measures. Panel (A) shows changes in the cough domain score using the Living with Idiopathic Pulmonary Fibrosis (L-IPF) scale; (B) presents changes in the total domain score via the L- IPF scale, and (C) displays changes in the cough domain score using the Raghu Scale for Pulmonary Fibrosis (R-Scale-PF). In Table E2 of Online Data Supplement , unadjusted and adjusted comparison between the yoga and control groups for secondary outcomes are shown using the multiple imputation approach. There were no significant differences in any of the secondary outcomes over 12 weeks. Findings from the sensitivity analyses are presented in Table E3 of Online Data Supplement . A qualitative content analysis was performed through participants’ journals. Central themes identified leading to sense of improvement in overall well-being included social connection, managing fibrosis symptoms, changed mindset ( Figure E2 of Online Data Supplement ). Regarding social connection, participants reported feeling a sense of community and support during the program. Participants felt less self-conscious about experiencing symptoms (such as cough) and enjoyed speaking with others about their experiences and being able to monitor their progress alongside others who shared their diagnosis. Several participants reported incorporating more deliberate and controlled breathing techniques into daily activities, with improved knowledge and understanding of the connection between mind and body. From a mindset standpoint, participants reported feeling an increase in confidence in their ability and motivation to increase physical activity and push themselves despite their debilitating diagnosis. 4. Discussion This pilot trial provides evidence that participants receiving 12-week modified yoga program experienced improvements in health-related quality-of-life outcomes, particularly in the cough domain scores of both the L-IPF and R-Scale-PF questionnaires, compared to those who continued usual daily activities. The strength of this conclusion is bolstered by consistency of results showing greater improvements in multiple quality of life instruments—including HADS, K-BILD, total R-scale-PF score, PROMIS SRI and ESS, following intervention in the yoga group than the control group. To our knowledge, this is the first idiopathic pulmonary fibrosis clinical trial reporting improvement in outcomes in the intervention group as primary endpoints. As emphasized by a recent landmark international symposium involving patients, academic investigators, and regulatory representatives, endpoints in idiopathic pulmonary fibrosis clinical trials should resonate more closely with the tangible patient experience 2 . The integration of adequately validated outcomes is an important step in this direction. The statistically significant improvement in the L-IPF cough domain score (and numeric improvement in KBILD score) in the yoga arm participants in our study is clinically meaningful to patients, as both of these questionnaires were developed with input from idiopathic pulmonary fibrosis patients and have undergone extensive validity and reliability testing 2 , 21 , 28 . In a patient population with progressive interstitial lung disease, other than idiopathic pulmonary fibrosis, Swigris et al. provided estimates of 4 to 5 points in the L-PF cough domain score as a clinically meaningful threshold 27 . Other scale tools, such as cough visual analogue scale, carry prognostic and quality of life value in fibrosis and are being increasingly used in interventional trials in idiopathic pulmonary fibrosis 32 , 33 . Previous studies have demonstrated a clear benefit of yoga in other chronic respiratory diseases on validated health-related quality-of-life scores, including asthma and COPD 8 , 9 , 34 , 35 . Our study is the first to evaluate the effect of yoga on patients with idiopathic pulmonary fibrosis with positive findings despite the barrier of virtual rather than in- person sessions due to the COVID-19 pandemic, particularly since previous data suggests participant preference for in-person yoga classes 36 . Two unpublished results showed mixed results regarding improvements in quality of life scores following participation in yoga, although both were designed as feasibility/safety studies with less than 20 participants each (one study in idiopathic pulmonary fibrosis patients and another in patients with fibrotic ILD of any cause) 37 , 38 . We did not find statistically significant improvement in anxiety and depression scores measured by the HADS in contrast to a previous study that evaluated a general group of chronic lung disease patients awaiting lung transplant 39 . Although numerically greater improvements in the ESS and PROMIS SRI scores were observed in the yoga group, our study did not show statistically significant benefit in sleep quality despite prior reports showing improvement in sleep quality and insomnia with yoga participation in other patient populations 40 . There is a complicated relationship with sleep quality in idiopathic pulmonary fibrosis patients, in whom comorbid sleep related breathing disorders such as OSA and insomnia are common and likely worsen the quality of life and may even increase mortality in patients with idiopathic pulmonary fibrosis 41 – 43 . Another factor reported to be potentially contributing to increased arousal index in idiopathic pulmonary fibrosis is comorbid gastroesophageal reflux disease 41 . Further prospective studies are needed to better evaluate the effects of yoga on overall sleep quality in idiopathic pulmonary fibrosis patients. Possibilities of the potential mechanism for improved quality of life in fibrosis patients participating in yoga include improved posture, allowing more efficient use of abdominal and diaphragmatic muscles. Various yoga exercises such as deep diaphragmatic breathing can improve vagal tone, which may help diminish enhanced cough reflex sensitivity as previously described in patients with idiopathic pulmonary fibrosis 44 . The results of this study must be interpreted in the context of several limitations amidst its strengths. First, this was a single center, pilot trial designed to assess feasibility with the aim of informing future studies with adequate sample size calculations and powered to detect significant differences in trial outcomes between groups. This was an exploratory pilot trial designed primarily to assess feasibility and generate hypotheses for future studies. We acknowledge that with multiple endpoints (21 in total) and no adjustment for multiple comparisons, our findings are vulnerable to Type I error. However, the consistency of findings across multiple cough-related measures strengthens our confidence in these specific results. Future confirmatory trials should pre-specify primary endpoints and include appropriate statistical adjustments. A second limitation is the relatively small sample size and study duration of only 12 weeks. Third, since a blinded trial is not possible, it is difficult to distinguish between yoga-specific and nonspecific benefits (e.g. expectation bias, social connection during class, interpersonal skills of the yoga instructor). Finally, future trials should include well-validated measures of cough such as The Leicester Cough Questionnaire 45 , 46 . In summary, this is the first idiopathic pulmonary fibrosis clinical trial demonstrating improvement in patient-reported outcomes as primary endpoints, and the first study to evaluate the effect of yoga practice in this patient population. Besides demonstrating safety and feasibility of a yoga program that patients can engage in from the comfort of their homes, the study demonstrated improved health-related quality of life measures in patients with idiopathic pulmonary fibrosis following participation in a yoga program supervised by instructors. These results are clinically significant given the critical need for therapeutic options that improve outcomes that are meaningful to patients suffering with this disease. A larger, multi-center trial is warranted to further establish improved health-related quality of life via participation in a yoga program tailored for patients with idiopathic pulmonary fibrosis, in keeping with an emphasis on patient-centered outcomes. Contributions Suha Kadura: Data gathering, interpretation of result, writing first draft, revised versions and collated inputs from all authors of the manuscript. Soumik Purkayastha: Data analyses, interpretation of result, writing first draft, revised versions and collated inputs from all authors of the manuscript. Josh Benditt and Amit Anand: Developed the protocol and study design for the modified yoga program /exercises used in the trial; reviewed the data analyzed, interpreted results. Josh Benditt, Amit Anand, Miguele De Quadros, Mafara Hobson, and MJ Biswas: Certified yoga instructors for patients. Bridget Collins: Enrolled consenting participants in the study, participated in study design, interpretation of results, reviewing manuscript and provided input. Lawrence Ho: Enrolled and encouraged patients to participate in the trial. Cathie Spino: Reviewed data analyses and interpretation, reviewed manuscript and provided input. Ganesh Raghu: designed the trial and study protocol, enrolled consenting participants in the study, interpretation of results, supervised the conduct of trial and execution of the trial; manuscript writing. All authors reviewed the drafts of manuscript, provided input, contributed to writing the manuscript and approved the final manuscript for submission. Data availability statement In accordance with our protocol registered at ClinicalTrials.gov ( NCT02848625 ), individual participant data from this study will not be made available publicly. This approach was established to protect participant privacy and confidentiality as stated in our informed consent process. Summary data supporting the findings of this study are available within the article and its supplementary materials. Researchers interested in collaborative analyses may contact the corresponding author with specific research questions and proposed methodologies for consideration. Funding Statement No external funding or financial support was received for the conduct of this research, data analysis, manuscript preparation, or submission. Footnotes Figure 2 is now a waterfall plot, not a spaghetti plot. Reduced word count to 3000 for submission to ERJ. REFERENCES 1. Raghu G , Remy-Jardin M , Richeldi L , et al. Idiopathic Pulmonary Fibrosis (an Update) and Progressive Pulmonary Fibrosis in Adults: An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline . Am J Respir Crit Care Med . 2022 ; 205 ( 9 ): e18 – e47 . doi: 10.1164/rccm.202202-0399ST OpenUrl CrossRef PubMed 2. ↵ Raghu G , Ghazipura M , Fleming TR , et al. Meaningful Endpoints for Idiopathic Pulmonary Fibrosis (IPF) Clinical Trials: Emphasis on ‘Feels, Functions, Survives’. Report of a Collaborative Discussion in a Symposium with Direct Engagement from Representatives of Patients, Investigators, the National Institutes of Health, a Patient Advocacy Organization, and a Regulatory Agency . Am J Respir Crit Care Med . 2024 ; 209 ( 6 ): 647 – 669 . doi: 10.1164/rccm.202312-2213SO OpenUrl CrossRef PubMed 3. Swigris JJ , Han M , Vij R , et al. The UCSD shortness of breath questionnaire has longitudinal construct validity in idiopathic pulmonary fibrosis . Respir Med . 2012 ; 106 ( 10 ): 1447 – 1455 . doi: 10.1016/j.rmed.2012.06.018 OpenUrl CrossRef PubMed 4. ↵ Aronson KI , Martin-Schwarze AM , Swigris JJ , et al. Validity and Reliability of the Fatigue Severity Scale in a Real-World Interstitial Lung Disease Cohort . Am J Respir Crit Care Med . 2023 ; 208 ( 2 ): 188 – 195 . doi: 10.1164/rccm.202208-1504OC OpenUrl CrossRef PubMed 5. ↵ 5. 2016 Yoga in America Study Conducted by Yoga Journal & Yoga Alliance . https://www.yogaalliance.org/2016YogaInAmericaStudy 6. ↵ Clarke TC , Barnes PM , Black LI , Stussman BJ , Nahin RL . Use of Yoga, Meditation, and Chiropractors Among U.S. Adults Aged 18 and Over . NCHS Data Brief . 2018 ;( 325 ): 1 – 8 . OpenUrl 7. ↵ Selvan P , Hriso C , Mitchell J , Newberg A . Systematic review of yoga for symptom management during conventional treatment of breast cancer patients . Complement Ther Clin Pract . 2022 ; 48 : 101581 . doi: 10.1016/j.ctcp.2022.101581 OpenUrl CrossRef PubMed 8. ↵ Holland AE , Hill CJ , Jones AY , McDonald CF . Breathing exercises for chronic obstructive pulmonary disease . Cochrane Airways Group, ed. Cochrane Database of Systematic Reviews. Published online October 17 , 2012 . doi: 10.1002/14651858.CD008250.pub2 OpenUrl CrossRef PubMed 9. ↵ Yang ZY , Zhong HB , Mao C , et al. Yoga for asthma . Cochrane Database Syst Rev . 2016 ; 4 ( 4 ):CD010346. doi: 10.1002/14651858.CD010346.pub2 OpenUrl CrossRef PubMed 10. Andrea Cortés-Ladino C , Augusto Arias-Ortiz W , Porras-Ramírez A . Effectiveness of Yoga and Acupuncture in Rheumatoid Arthritis: A Systematic Review and Meta- Analysis . Evid Based Complement Alternat Med . 2023 ; 2023 : 9098442 . doi: 10.1155/2023/9098442 OpenUrl CrossRef PubMed 11. Chow SL , Bozkurt B , Baker WL , et al. Complementary and Alternative Medicines in the Management of Heart Failure: A Scientific Statement From the American Heart Association . Circulation . 2023 ; 147 ( 2 ): e4 – e30 . doi: 10.1161/CIR.0000000000001110 OpenUrl CrossRef PubMed 12. ↵ Qaseem A , Wilt TJ , McLean RM , et al. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians . Ann Intern Med . 2017 ; 166 ( 7 ): 514 – 530 . doi: 10.7326/M16-2367 OpenUrl CrossRef PubMed 13. ↵ Vitacca M , Clini E , Bianchi L , Ambrosino N . Acute effects of deep diaphragmatic breathing in COPD patients with chronic respiratory insufficiency . Eur Respir J . 1998 ; 11 ( 2 ): 408 – 415 . doi: 10.1183/09031936.98.11020408 OpenUrl Abstract / FREE Full Text 14. Goyeche JR , Ago Y , Ikemi Y . Asthma: The yoga perspective. Part I. The somatopsychic imbalance in asthma: towards a holistic therapy . J Asthma Res . 1980 ; 17 ( 3 ): 111 – 121 . doi: 10.3109/02770908009105671 OpenUrl CrossRef PubMed 15. Satish V , Rao RM , Manjunath NK , et al. Yoga versus physical exercise for cardio- respiratory fitness in adolescent school children: a randomized controlled trial . Int J Adolesc Med Health . 2018 ; 32 ( 3 ). doi: 10.1515/ijamh-2017-0154 OpenUrl CrossRef 16. ↵ Shaw I , Shaw BS , Brown GA . Role of diaphragmatic breathing and aerobic exercise in improving pulmonary function and maximal oxygen consumption in asthmatics . Science & Sports . 2010 ; 25 ( 3 ): 139 – 145 . doi: 10.1016/j.scispo.2009.10.003 OpenUrl CrossRef 17. ↵ Raghu G , Remy-Jardin M , Myers JL , et al. Diagnosis of Idiopathic Pulmonary Fibrosis. An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline . Am J Respir Crit Care Med . 2018 ; 198 ( 5 ): e44 – e68 . doi: 10.1164/rccm.201807-1255ST OpenUrl CrossRef PubMed 18. ↵ Park J , McCaffrey R , Newman D , Liehr P , Ouslander JG . A Pilot Randomized Controlled Trial of the Effects of Chair Yoga on Pain and Physical Function Among Community-Dwelling Older Adults With Lower Extremity Osteoarthritis . J American Geriatrics Society . 2017 ; 65 ( 3 ): 592 – 597 . doi: 10.1111/jgs.14717 OpenUrl CrossRef 19. ↵ Swigris JJ , Andrae DA , Churney T , et al. Development and Initial Validation Analyses of the Living with Idiopathic Pulmonary Fibrosis Questionnaire . Am J Respir Crit Care Med . 2020 ; 202 ( 12 ): 1689 – 1697 . doi: 10.1164/rccm.202002-0415OC OpenUrl CrossRef PubMed 20. ↵ Scallan C , Strand L , Hayes J , et al. R-scale for pulmonary fibrosis: a simple, visual tool for the assessment of health-related quality of life . Eur Respir J . 2022 ; 59 ( 1 ): 2100917 . doi: 10.1183/13993003.00917-2021 OpenUrl Abstract / FREE Full Text 21. ↵ Patel AS , Siegert RJ , Brignall K , et al. The development and validation of the King’s Brief Interstitial Lung Disease (K-BILD) health status questionnaire . Thorax . 2012 ; 67 ( 9 ): 804 – 810 . doi: 10.1136/thoraxjnl-2012-201581 OpenUrl Abstract / FREE Full Text 22. Zigmond AS , Snaith RP . The hospital anxiety and depression scale . Acta Psychiatr Scand . 1983 ; 67 ( 6 ): 361 – 370 . doi: 10.1111/j.1600-0447.1983.tb09716.x OpenUrl CrossRef PubMed Web of Science 23. Johns MW . A new method for measuring daytime sleepiness: the Epworth sleepiness scale . Sleep . 1991 ; 14 ( 6 ): 540 – 545 . doi: 10.1093/sleep/14.6.540 OpenUrl CrossRef PubMed Web of Science 24. EuroQol Group . EuroQol--a new facility for the measurement of health-related quality of life . Health Policy . 1990 ; 16 ( 3 ): 199 – 208 . doi: 10.1016/0168-8510(90)90421-9 OpenUrl CrossRef PubMed Web of Science 25. Buysse DJ , Yu L , Moul DE , et al. Development and validation of patient-reported outcome measures for sleep disturbance and sleep-related impairments . Sleep . 2010 ; 33 ( 6 ): 781 – 792 . doi: 10.1093/sleep/33.6.781 OpenUrl CrossRef PubMed Web of Science 26. ↵ Yu L , Buysse DJ , Germain A , et al. Development of short forms from the PROMIS TM sleep disturbance and Sleep-Related Impairment item banks . Behav Sleep Med . 2011 ; 10 ( 1 ): 6 – 24 . doi: 10.1080/15402002.2012.636266 OpenUrl CrossRef PubMed Web of Science 27. ↵ Swigris JJ , Bushnell DM , Rohr K , Mueller H , Baldwin M , Inoue Y . Responsiveness and meaningful change thresholds of the Living with Pulmonary Fibrosis (L-PF) questionnaire Dyspnoea and Cough scores in patients with progressive fibrosing interstitial lung diseases . BMJ Open Respir Res . 2022 ; 9 ( 1 ): e001167 . doi: 10.1136/bmjresp-2021-001167 OpenUrl Abstract / FREE Full Text 28. ↵ Swigris J , Cutts K , Male N , Baldwin M , Rohr KB , Bushnell DM . The Living with Pulmonary Fibrosis questionnaire in progressive fibrosing interstitial lung disease . ERJ Open Res . 2021 ; 7 ( 2 ): 00145 – 02020 . doi: 10.1183/23120541.00145-2020 OpenUrl Abstract / FREE Full Text 29. Nolan CM , Birring SS . PROMising developments in IPF patient-reported outcome measures . Eur Respir J . 2022 ; 59 ( 1 ): 2102312 . doi: 10.1183/13993003.02312-2021 OpenUrl Abstract / FREE Full Text 30. Moor CC , Mostard RLM , Grutters JC , Bresser P , Wijsenbeek MS . The use of online visual analogue scales in idiopathic pulmonary fibrosis . Eur Respir J . 2022 ; 59 ( 1 ): 2101531 . doi: 10.1183/13993003.01531-2021 OpenUrl Abstract / FREE Full Text 31. Swigris JJ , Pryor JB , Aronson KI , Guess TA , Solomon JJ . Interstitial Lung Disease Patients’ Global Impressions of Symptoms, Severity Ratings, and Meaningfulness of Changes Over Time . Ann Am Thorac Soc . Published online August 12, 2024 . doi: 10.1513/AnnalsATS.202405-457OC OpenUrl CrossRef 32. ↵ Khor YH , Johannson KA , Marcoux V , et al. Epidemiology and Prognostic Significance of Cough in Fibrotic Interstitial Lung Disease . Am J Respir Crit Care Med. Published online March 27 , 2024 :rccm.202311-2101OC. doi: 10.1164/rccm.202311-2101OC OpenUrl CrossRef PubMed 33. ↵ Wu Z , Smith DJF , Yazbeck L , et al. Cough Severity Visual Analog Scale Assesses Cough Burden and Predicts Survival in Idiopathic Pulmonary Fibrosis . Am J Respir Crit Care Med . 2024 ; 209 ( 9 ): 1165 – 1167 . doi: 10.1164/rccm.202311-2169LE OpenUrl CrossRef PubMed 34. ↵ Anshu null , Singh N , Deka S , et al. The effect of yoga on pulmonary function in patients with asthma: A meta-analysis . Complement Ther Clin Pract . 2023 ; 50 : 101682 . doi: 10.1016/j.ctcp.2022.101682 OpenUrl CrossRef PubMed 35. ↵ Cai Y , Ren X , Wang J , Ma B , Chen O . Effects of Breathing Exercises in Patients With Chronic Obstructive Pulmonary Disease: A Network Meta-analysis . Arch Phys Med Rehabil . 2024 ; 105 ( 3 ): 558 – 570 . doi: 10.1016/j.apmr.2023.04.014 OpenUrl CrossRef PubMed 36. ↵ Brinsley J , Smout M , Davison K . Satisfaction with Online Versus In-Person Yoga During COVID-19 . J Altern Complement Med . 2021 ; 27 ( 10 ): 893 – 896 . doi: 10.1089/acm.2021.0062 OpenUrl CrossRef PubMed 37. ↵ Fell CD , Jessa I , Hatley S , Crawford L , Culos-Reed N . Yoga For Idiopathic Pulmonary Fibrosis: A Pilot Study . In: A42. NOVEL PHENOTYPES, OUTCOME MEASURES, TREATMENT STRATEGIES, AND COMORBID ILLNESS . American Thoracic Society; 2011 :A1527-A1527. doi: 10.1164/ajrccm-conference.2011.183.1_MeetingAbstracts.A1527 OpenUrl CrossRef 38. ↵ Kreuter M , Wasmuth L , Kotzerke M , et al. Yoga in patients with fibrosing interstitial lung diseases – a feasibility trial . In: Idiopathic Interstitial Pneumonias. European Respiratory Society ; 2020 : 773 . doi: 10.1183/13993003.congress-2020.773 OpenUrl CrossRef 39. ↵ Santana MJ , S-Parrilla J , Mirus J , Loadman M , Lien DC , Feeny D . An assessment of the effects of Iyengar yoga practice on the health-related quality of life of patients with chronic respiratory diseases: a pilot study . Can Respir J . 2013 ; 20 ( 2 ): e17 – 23 . doi: 10.1155/2013/265406 OpenUrl CrossRef PubMed 40. ↵ Wang WL , Chen KH , Pan YC , Yang SN , Chan YY . The effect of yoga on sleep quality and insomnia in women with sleep problems: a systematic review and meta- analysis . BMC Psychiatry . 2020 ; 20 ( 1 ): 195 . doi: 10.1186/s12888-020-02566-4 OpenUrl CrossRef PubMed 41. ↵ Hagmeyer L , Herkenrath SD , Treml M , Pietzke-Calcagnile A , Anduleit N , Randerath W . Sleep-related breathing disorders in idiopathic pulmonary fibrosis are frequent and may be associated with pulmonary vascular involvement . Sleep Breath . 2023 ; 27 ( 3 ): 961 – 971 . doi: 10.1007/s11325-022-02686-z OpenUrl CrossRef PubMed 42. Kolilekas L , Manali E , Vlami KA , et al. Sleep Oxygen Desaturation Predicts Survival in Idiopathic Pulmonary Fibrosis . Journal of Clinical Sleep Medicine . 2013 ; 09 ( 06 ): 593 – 601 . doi: 10.5664/jcsm.2758 OpenUrl CrossRef 43. ↵ Troy LK , Young IH , Lau EMT , et al. Nocturnal hypoxaemia is associated with adverse outcomes in interstitial lung disease . Respirology . 2019 ; 24 ( 10 ): 996 – 1004 . doi: 10.1111/resp.13549 OpenUrl CrossRef PubMed 44. ↵ van Manen MJG , Birring SS , Vancheri C , et al. Cough in idiopathic pulmonary fibrosis . Eur Respir Rev . 2016 ; 25 ( 141 ): 278 – 286 . doi: 10.1183/16000617.0090-2015 OpenUrl Abstract / FREE Full Text 45. ↵ Birring SS . Development of a symptom specific health status measure for patients with chronic cough: Leicester Cough Questionnaire (LCQ) . Thorax . 2003 ; 58 ( 4 ): 339 – 343 . doi: 10.1136/thorax.58.4.339 OpenUrl Abstract / FREE Full Text 46. ↵ Key AL , Holt K , Hamilton A , Smith JA , Earis JE . Objective cough frequency in Idiopathic Pulmonary Fibrosis . Cough . 2010 ; 6 ( 1 ): 4 . doi: 10.1186/1745-9974-6-4 OpenUrl CrossRef PubMed 47. Stanojevic S , Kaminsky DA , Miller MR , et al. ERS/ATS technical standard on interpretive strategies for routine lung function tests . Eur Respir J . 2022 ; 60 ( 1 ): 2101499 . doi: 10.1183/13993003.01499-2021 OpenUrl Abstract / FREE Full Text View the discussion thread. Back to top Previous Next Posted July 13, 2025. Download PDF Supplementary Material Data/Code Email Thank you for your interest in spreading the word about medRxiv. NOTE: Your email address is requested solely to identify you as the sender of this article. Your Email * Your Name * Send To * Enter multiple addresses on separate lines or separate them with commas. You are going to email the following Yoga Effect on Quality-of-Life Study Among Patients with Idiopathic Pulmonary Fibrosis (YES-IPF) Message Subject (Your Name) has forwarded a page to you from medRxiv Message Body (Your Name) thought you would like to see this page from the medRxiv website. Your Personal Message CAPTCHA This question is for testing whether or not you are a human visitor and to prevent automated spam submissions. Share Yoga Effect on Quality-of-Life Study Among Patients with Idiopathic Pulmonary Fibrosis (YES-IPF) Suha Kadura , Soumik Purkayastha , Josh Benditt , Amit Anand , Bridget Collins , Miguele De Quadros , Mafara Hobson , MJ Biswas , Lawrence Ho , Cathie Spino , Ganesh Raghu medRxiv 2025.05.20.25327762; doi: https://doi.org/10.1101/2025.05.20.25327762 Share This Article: Copy Citation Tools Yoga Effect on Quality-of-Life Study Among Patients with Idiopathic Pulmonary Fibrosis (YES-IPF) Suha Kadura , Soumik Purkayastha , Josh Benditt , Amit Anand , Bridget Collins , Miguele De Quadros , Mafara Hobson , MJ Biswas , Lawrence Ho , Cathie Spino , Ganesh Raghu medRxiv 2025.05.20.25327762; doi: https://doi.org/10.1101/2025.05.20.25327762 Citation Manager Formats BibTeX Bookends EasyBib EndNote (tagged) EndNote 8 (xml) Medlars Mendeley Papers RefWorks Tagged Ref Manager RIS Zotero Tweet Widget Facebook Like Google Plus One Subject Area Respiratory Medicine Subject Areas All Articles Addiction Medicine (568) Allergy and Immunology (863) Anesthesia (299) Cardiovascular Medicine (4425) Dentistry and Oral Medicine (443) Dermatology (382) Emergency Medicine (607) Endocrinology (including Diabetes Mellitus and Metabolic Disease) (1507) Epidemiology (15221) Forensic Medicine (30) Gastroenterology (1123) Genetic and Genomic Medicine (6588) Geriatric Medicine (667) Health Economics (997) Health Informatics (4524) Health Policy (1368) Health Systems and Quality Improvement (1612) Hematology (540) HIV/AIDS (1264) Infectious Diseases (except HIV/AIDS) (15910) Intensive Care and Critical Care Medicine (1103) Medical Education (623) Medical Ethics (145) Nephrology (667) Neurology (6588) Nursing (346) Nutrition (998) Obstetrics and Gynecology (1143) Occupational and Environmental Health (956) Oncology (3331) Ophthalmology (970) Orthopedics (369) Otolaryngology (420) Pain Medicine (435) Palliative Medicine (129) Pathology (663) Pediatrics (1690) Pharmacology and Therapeutics (691) Primary Care Research (710) Psychiatry and Clinical Psychology (5440) Public and Global Health (9219) Radiology and Imaging (2195) Rehabilitation Medicine and Physical Therapy (1369) Respiratory Medicine (1196) Rheumatology (593) Sexual and Reproductive Health (710) Sports Medicine (529) Surgery (710) Toxicology (99) Transplantation (289) Urology (265) (function(){function c(){var b=a.contentDocument||a.contentWindow.document;if(b){var d=b.createElement('script');d.innerHTML="window.__CF$cv$params={r:'9ffc39c0fe97aa64',t:'MTc3OTQ1NzE1Mg=='};var a=document.createElement('script');a.src='/cdn-cgi/challenge-platform/scripts/jsd/main.js';document.getElementsByTagName('head')[0].appendChild(a);";b.getElementsByTagName('head')[0].appendChild(d)}}if(document.body){var a=document.createElement('iframe');a.height=1;a.width=1;a.style.position='absolute';a.style.top=0;a.style.left=0;a.style.border='none';a.style.visibility='hidden';document.body.appendChild(a);if('loading'!==document.readyState)c();else if(window.addEventListener)document.addEventListener('DOMContentLoaded',c);else{var e=document.onreadystatechange||function(){};document.onreadystatechange=function(b){e(b);'loading'!==document.readyState&&(document.onreadystatechange=e,c())}}}})();
Text is read by the "Ask this paper" AI Q&A widget below.
Extraction quality varies by source — PMC NXML preserves structure
cleanly, OA-HTML may include some navigation residue, and OA-PDF can
have broken hyphenation. The publisher copy
(via DOI)
is the canonical version.