Yoga Effect on Quality of Life Study Among Patients With Idiopathic Pulmonary Fibrosis (YES-IPF)

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.

Study Overview

• Status: Unknown
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Other: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ganesh Raghu, MD; Phone Number: 206-598-4967; Email: graghu@uw.edu
• Study Contact Backup: Name: Bridget Collins, MD; Phone Number: 206-598-4967; Email: bfc3@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group A; Patients randomized to 12 weeks of twice weekly yoga sessions. The yoga exercises have been designed specifically for patients with IPF.	Other: Yoga; Yoga and breathing exercises designed for patients with IPF. Sessions will be two times per week for 12 weeks
NO_INTERVENTION: Group B; 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	Time Frame
Quality of life	12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Ganesh Raghu, MD, University of Washington, Center for Interstitial Lung Diseases; Principal Investigator: Bridget F Collins, MD, University of Washington, Center for Interstitial Lung Diseases

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (ANTICIPATED): April 1, 2018
• Study Completion (ANTICIPATED): April 1, 2018

Study Registration Dates

• First Submitted: July 26, 2016
• First Submitted That Met QC Criteria: July 26, 2016
• First Posted (ESTIMATE): July 28, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): July 28, 2016
• Last Update Submitted That Met QC Criteria: July 26, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Yoga; Quality of life; Idiopathic Pulmonary Fibrosis
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: 51411-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO