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.

The authors have declared no competing interest.

NCT02848625

No external funding or financial support was received for the conduct of this research, data analysis, manuscript preparation, or submission.

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

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).

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Yes

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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.

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.

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.