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

Study Overview
=================
Brief 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.

Detailed 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.

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

Conditions
-----------------
Idiopathic Pulmonary Fibrosis

Intervention / Treatment
-----------------
* Other: Yoga


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Patients randomized to 12 weeks of twice weekly yoga sessions. The yoga exercises have been designed specifically for patients with IPF. | Other: Yoga<br>* Yoga and breathing exercises designed for patients with IPF. Sessions will be two times per week for 12 weeks<br>|
| No Intervention: Group B<br>Patients who are not randomized to yoga sessions will continue with their usual care and usual activities | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in forced vital capacity |  | 12 weeks | 
| change in 6 minute walk distance |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Idiopathic Pulmonary Fibrosis, Yoga, Quality of life