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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00692796
Other study ID # NJMRC HS 1603 substudy
Secondary ID
Status Completed
Phase N/A
First received June 4, 2008
Last updated March 27, 2017
Start date April 2008
Est. completion date March 2010

Study information

Verified date March 2017
Source National Jewish Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the effects of Pulmonary Rehabilitation (PR) on shortness of breath, exercise capacity, symptom control, mental health, cognitive function, and quality of life in patients with Idiopathic Pulmonary Fibrosis (IPF). Pulmonary rehabilitation has already been shown to benefit patients with other chronic respiratory diseases, such as chronic obstructive pulmonary disease (COPD). We believe that pulmonary rehabilitation will benefit patients with IPF as well.


Description:

The goals of this project are to assess the effect of PR on a number of important outcomes in patients with IPF. Once enrolled in the study, subjects will complete a battery of questionnaires and tests that assess symptoms, quality of life, cognition, and mental health, and then subjects will complete a six week outpatient PR program (at National Jewish Medical and Research Center or other PR programs). Subjects will complete the same battery of questionnaires and tests immediately after completion of the PR program and again six months later.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender All
Age group 40 Years to 90 Years
Eligibility Inclusion Criteria:

- Age 40 years or older

- Diagnosis of IPF according to American Thoracic Society criteria

Exclusion criteria:

- Patients who have completed a PR program within the last two years

- Patients with unstable medical conditions that would make PR unsafe

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Pulmonary rehabilitation
Pulmonary rehabilitation is a multi-disciplinary program that includes exercise training, disease education, psychosocial education (e.g., stress management, coping with chronic illness) and nutrition education.

Locations

Country Name City State
United States National Jewish Medical and Research Center Denver Colorado

Sponsors (2)

Lead Sponsor Collaborator
National Jewish Health Mordecai Palliative Care Research Fund

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Exercise capacity 6 weeks and again at 6 months
Secondary Cognition 6 weeks and again at 6 months
Secondary Quality of life 6 weeks and again at 6 months
Secondary Fatigue 6 weeks and again at 6 months
Secondary Anxiety 6 weeks and again at 6 months
Secondary Depression 6 weeks and again at 6 months
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