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

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ClinicalTrials.gov Identifier: NCT02848625
Recruitment Status : Not yet recruiting
First Posted : July 28, 2016
Last Update Posted : July 28, 2016
Sponsor:
Information provided by (Responsible Party):
Bridget Collins, University of Washington

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.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Other: Yoga Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Yoga Effect on Quality of Life Study Among Patients With Idiopathic Pulmonary Fibrosis
Study Start Date : August 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018


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



Primary Outcome Measures :
  1. Quality of life [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. change in forced vital capacity [ Time Frame: 12 weeks ]
  2. change in 6 minute walk distance [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848625


Contacts
Contact: Ganesh Raghu, MD 206-598-4967 graghu@uw.edu
Contact: Bridget Collins, MD 206-598-4967 bfc3@uw.edu

Sponsors and Collaborators
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

Responsible Party: Bridget Collins, Co-Principal Investigator (Ganesh Raghu, MD is Principal Investigator), University of Washington
ClinicalTrials.gov Identifier: NCT02848625     History of Changes
Other Study ID Numbers: 51411-A
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: July 28, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Bridget Collins, University of Washington:
Idiopathic Pulmonary Fibrosis
Yoga
Quality of life

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial