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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01055730
Other study ID # PR-ILD
Secondary ID
Status Completed
Phase N/A
First received January 25, 2010
Last updated November 19, 2013
Start date February 2010
Est. completion date January 2013

Study information

Verified date November 2013
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study is to determine if pulmonary rehabilitation has any effect on breathlessness, quality of life, physical function and depression in persons with interstitial lung disease.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Both
Age group 19 Years and older
Eligibility Inclusion Criteria:

- Adults (> 18 years old) with a diagnosis of ILD who are referred to a participating PR program

Exclusion Criteria:

- Inability to provide informed consent

- Inability to read and write English

- Any other medical condition that significantly limits the subject's ability to perform the functional measures

- Emphysema / Chronic bronchitis (FEV1 / FVC ratio < 60%)

- Previous pulmonary rehabilitation

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Other:
Pulmonary rehabilitation
Structured education and supervised exercise program, lasting between 6 and 9 weeks.

Locations

Country Name City State
Canada University of British Columbia Vancouver British Columbia
United States John Muir Health Concord California
United States Seton Pulmonary & Cardiac Rehabilitation Daly City California
United States Duke University Medical Center Durham North Carolina
United States Inova Fairfax Hospital Falls Church Virginia
United States Yale University School of Medicine New Haven Connecticut

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Francisco

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 6-minute walk distance Immediately following completion of pulmonary rehabilitation and 6 months following the start of pulmonary rehabilitation No
Primary Quality of life Immediately following completion of pulmonary rehabilitation and 6 months following the start of pulmonary rehabilitation No
Secondary Dyspnea Immediately following completion of pulmonary rehabilitation and 6 months following the start of pulmonary rehabilitation No
Secondary Depression Immediately following completion of pulmonary rehabilitation and 6 months following the start of pulmonary rehabilitation No
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