Yoga for Idiopathic Pulmonary Fibrosis

(YES-IPF Trial)

Overseen By Bridget Collins, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Paralysis, Musculoskeletal discomfort, Lung transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 24

Duration: 12 weeks

61 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on adding yoga to your routine rather than changing your medication.

What data supports the effectiveness of the treatment Yoga, Mindfulness Program, Meditation Program, Yoga Therapy for Idiopathic Pulmonary Fibrosis?

Research suggests that mindfulness-based stress reduction programs can be safe and beneficial for patients with interstitial lung diseases, improving psychological well-being. Additionally, yoga has been shown to help lung cancer survivors with breathing ease and respiratory function, which may be relevant for those with idiopathic pulmonary fibrosis. ^{1 2 3 4 5}

Is yoga safe for people with various health conditions?

Research shows that yoga is generally safe for people, with no significant difference in serious or nonserious adverse events compared to usual care or exercise. However, there may be more minor issues compared to psychological or educational interventions. ^{1 6 7 8 9}

How does the Yoga treatment for idiopathic pulmonary fibrosis differ from other treatments?

Yoga, as a treatment for idiopathic pulmonary fibrosis, is unique because it focuses on mindfulness and stress reduction, which can help improve the psychological and emotional well-being of patients. Unlike traditional medical treatments, it does not involve medication but instead uses techniques like meditation and breathing exercises to potentially enhance quality of life. ^{1 10 11 12 13}

What is the purpose of this trial?

This study will evaluate whether regular yoga exercises designed specifically for patients with Idiopathic Pulmonary Fibrosis is associated with any change in quality of life. Half of the participants will be randomized to yoga, half to usual care. Yoga was conducted live, virtually, in the setting of the COVID Pandemic.

Research Team

Bridget F Collins, MD

Principal Investigator

University of Washington, Center for Interstitial Lung Diseases

Ganesh Raghu, MD

Principal Investigator

University of Washington, Center for Interstitial Lung Diseases

Eligibility Criteria

This trial is for adults over 18 with Idiopathic Pulmonary Fibrosis who can give informed consent and are followed at the University of Washington Medical Center's Center for Interstitial Lung Disease. Details on who cannot participate are not provided.

Inclusion Criteria

I am 18 or older with IPF and can give informed consent.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants randomized to 12 weeks of twice weekly yoga sessions conducted virtually

12 weeks

24 virtual sessions

Follow-up

Participants are monitored for changes in quality of life after the yoga intervention

4 weeks

Treatment Details

Interventions

• Yoga

Trial Overview The study tests if yoga, tailored for those with Idiopathic Pulmonary Fibrosis and conducted virtually, affects their quality of life compared to usual care. Participants will be randomly assigned to either the yoga group or a control group receiving standard care.

Participant Groups

Group I: Group A Experimental Treatment 1 Intervention

Patients randomized to 12 weeks of twice weekly yoga sessions. The yoga exercises have been designed specifically for patients with IPF. Yoga sessions were virtual in the setting of the COVID Pandemic

Group II: Group B Active Control 1 Intervention

Patients who are not randomized to yoga sessions will continue with their usual care and usual activities

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Findings from Research

Patients with fibrotic idiopathic interstitial pneumonia showed improvements in exercise tolerance, anxiety, depression, and quality of life after participating in a pulmonary rehabilitation program.

The rehabilitation program was effective without increasing the patients' daily physical activity levels, suggesting that structured rehabilitation can enhance well-being without requiring more physical exertion in their daily lives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of pulmonary rehabilitation on daily life physical activity of fibrotic idiopathic interstitial pneumonia patients. Wallaert, B., Masson, N., Le Rouzic, O., et al.[2022]

A systematic review of 94 randomized controlled trials involving 8,430 participants found that yoga is as safe as usual care and exercise, with no significant differences in serious adverse events or dropouts due to adverse events.

While yoga had a higher occurrence of nonserious adverse events compared to psychological or educational interventions, the overall safety profile suggests that it is a viable therapeutic option, highlighting the need for better reporting of safety data in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Cramer, H., Ward, L., Saper, R., et al.[2018]

A pilot study involving 21 patients with fibrotic interstitial lung disease showed that a 12-week home-based pulmonary rehabilitation program improved patient-reported outcomes related to dyspnea and quality of life, although the results were not statistically significant due to the small sample size.

Qualitative feedback indicated that participants, despite having varying expectations and disease severity, found the program beneficial for coping with their condition, highlighting the importance of psychological support alongside physical rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-Based Pulmonary Rehabilitation and Health Coaching in Fibrotic Interstitial Lung Disease: IMPLEMENTATION AND QUALITATIVE ASSESSMENT OF A PILOT TELEHEALTH PROGRAM. Duke, JD., Moua, T., Ridgeway, JL., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction in patients with interstitial lung diseases: a pilot, single-centre observational study on safety and efficacy. [2018]

2. Germany pubmed.ncbi.nlm.nih.gov

Using a standardized Viniyoga protocol for lung cancer survivors: a pilot study examining effects on breathing ease. [2017]

3. Australia pubmed.ncbi.nlm.nih.gov

Rehabilitation and palliative care in lung fibrosis. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Effects of pulmonary rehabilitation on daily life physical activity of fibrotic idiopathic interstitial pneumonia patients. [2022]

5. China pubmed.ncbi.nlm.nih.gov

New pulmonary rehabilitation exercise for pulmonary fibrosis to improve the pulmonary function and quality of life of patients with idiopathic pulmonary fibrosis: a randomized control trial. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Yoga Therapy in Children with Cystic Fibrosis Decreases Immediate Anxiety and Joint Pain. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2018]

8. Egypt pubmed.ncbi.nlm.nih.gov

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. [2022]

9. England pubmed.ncbi.nlm.nih.gov

The risks and benefits of yoga for patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis. [2022]

10. France pubmed.ncbi.nlm.nih.gov

[Home-based pulmonary rehabilitation in idiopathic pulmonary fibrosis]. [2019]

11. France pubmed.ncbi.nlm.nih.gov

Home-based pulmonary rehabilitation in idiopathic pulmonary fibrosis. [2022]

12. Germany pubmed.ncbi.nlm.nih.gov

Deciphering the molecular mechanisms of Maxing Huoqiao Decoction in treating pulmonary fibrosis via transcriptional profiling and circRNA-miRNA-mRNA network analysis. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Home-Based Pulmonary Rehabilitation and Health Coaching in Fibrotic Interstitial Lung Disease: IMPLEMENTATION AND QUALITATIVE ASSESSMENT OF A PILOT TELEHEALTH PROGRAM. [2023]