Pulmonary Rehabilitation for Idiopathic Pulmonary Fibrosis

March 27, 2017 updated by: National Jewish Health
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Medical and Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Exercise capacity
Time Frame: 6 weeks and again at 6 months
6 weeks and again at 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Cognition
Time Frame: 6 weeks and again at 6 months
6 weeks and again at 6 months
Quality of life
Time Frame: 6 weeks and again at 6 months
6 weeks and again at 6 months
Fatigue
Time Frame: 6 weeks and again at 6 months
6 weeks and again at 6 months
Anxiety
Time Frame: 6 weeks and again at 6 months
6 weeks and again at 6 months
Depression
Time Frame: 6 weeks and again at 6 months
6 weeks and again at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Jewish Health

Collaborators

Mordecai Palliative Care Research Fund

Investigators

  • Principal Investigator: Jeff Swigris, DO, MS, National Jewish Medical and Research Center (Jeffrey J. Swigris, DO, MS; Assistant Professor of Medicine)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (ACTUAL)

March 1, 2010

Study Completion (ACTUAL)

March 1, 2010

Study Registration Dates

First Submitted

June 4, 2008

First Submitted That Met QC Criteria

June 4, 2008

First Posted (ESTIMATE)

June 6, 2008

Study Record Updates

Last Update Posted (ACTUAL)

March 29, 2017

Last Update Submitted That Met QC Criteria

March 27, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NJMRC HS 1603 substudy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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