Yoga Effect on Quality of Life Study Among Patients With Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis Clinical Trial

— YES-IPF  

Official title:

Yoga Effect on Quality of Life Study Among Patients With Idiopathic Pulmonary Fibrosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02848625
• Other study ID #: 51411-A
• Status: Not yet recruiting
• Phase: N/A
• First received: July 26, 2016
• Last updated: July 26, 2016
• Start date: August 2016
• Est. completion date: April 2018

Study information

• Verified date: July 2016
• Source: University of Washington
• Contact: Ganesh Raghu, MD
• Phone: 206-598-4967
• Email: graghu[@]uw.edu
• Is FDA regulated: No
• Health authority: USA: University of Washington IRB
• Study type: Interventional

Clinical Trial Summary

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. After the first group completes 12 weeks of yoga, the patients who were randomized to usual care will completed 12 weeks of yoga.

Description:

Idiopathic Pulmonary Fibrosis (IPF) is a chronic progressive fibrotic (scarring) disease of the lung of unknown cause. Approximately 100,000 Americans will die from IPF this year. There is no cure for IPF other than lung transplantation, which only 1% of patients will receive. Recently, 2 drugs were approved by the FDA to slow the rate of decline in lung function among patients with IPF. These drugs do not decrease symptoms or improve quality of life.

Symptoms of IPF include shortness of breath, cough, and fatigue, all of which may also adversely affect quality of life. Yoga is a practice of exercises, including breathing exercises, that has been shown to be relatively safe and to improve quality of life in some patients with other advanced lung diseases. We hypothesize that regular yoga and breathing exercises, specifically designed for patients with Idiopathic Pulmonary Fibrosis, over a period of 12 weeks will lead to improved quality of life as measured by several different quality of life questionnaires.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria: Adults 18 years of age or older. We will include all consecutive consenting patients with IPF who are able to provide informed consent and are seen and followed at the Center for Interstitial Lung Disease at the University of Washington Medical Center.

Exclusion Criteria: Subjects with comorbid diseases that would prohibit them from taking part in yoga will be excluded at the discretion of the clinical-investigators. Such comorbid diseases would include paralysis, musculoskeletal discomfort that would interfere with participation or broken limbs. Since we are interested in the effect of yoga among subjects with IPF, we will exclude subjects who have previously received lung transplantation. To assess the effect "new" or "initial" participation in a yoga program with breathing exercises on quality of life, subjects who are regularly participating in yoga (outside of the study) will be excluded.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Other:
• Yoga
Yoga and breathing exercises designed for patients with IPF. Sessions will be two times per week for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life		12 weeks	No
Secondary	change in forced vital capacity		12 weeks	No
Secondary	change in 6 minute walk distance		12 weeks	No