Beneficial Effects of Pulmonary Rehabilitation for Idiopathic Pulmonary Fibrosis

Completed

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Other: Standard pulmonary rehabilitation program

• Registration Number: NCT01107028
• Lead Sponsor: National Jewish Health

Brief Summary

Idiopathic pulmonary fibrosis (IPF) is a devastating disease marked by progressive lung scarring leading to multiple life-altering sequelae. The over-arching goals of the principal investigator's research program are to more fully characterize these sequelae and to examine interventions that might improve them. The hypotheses of this particular study are that pulmonary rehabilitation (PR) is one such intervention, and that PR will improve the sequelae of dyspnea and impairments in functional capacity, cognition, mood and anxiety, fatigue, and quality of life (QOL) in patients with IPF.

Detailed Description

Subjects will come to our center to be enrolled. Baseline data collection (performance of a six-minute walk test and completion of questionnaires) and randomization to one of two groups--either Rehab or Wait--will take place at the same enrollment visit if time permits. Subjects in either group will complete pulmonary rehabilitation, just at slightly different times, depending on which group they are randomized to.

Pulmonary rehabilitation is a program run by respiratory and/or physical therapists and other health professionals that involves exercise, education, and support with the goals to improve functional capacity, symptom management, and well-being. It will last 6-8 weeks, during which time, subjects will complete 18 approximately hour-long sessions. Pulmonary rehabilitation may be completed at any local center that makes travel convenient.

Data collection visits will take place at National Jewish Health at baseline, eight weeks (without intervening pulmonary rehabilitation in the Wait group), after completion of pulmonary rehabilitation (time varies, depending on the randomization group), and finally six months after completion of the pulmonary rehabilitation program.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-04-16
• Study First Submitted QC: 2010-04-19
• Study First Posted: 2010-04-20
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-19
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• Age > 40 years
• IPF
• Able to walk unassisted for balance
• Able to speak and understand English well enough to complete complex tasks with directions given in English

Exclusion Criteria

• Pulmonary fibrosis not due to IPF
• Coexisting comorbid conditions that would make exercise contraindicated

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rehab	Standard pulmonary rehabilitation program	Subjects randomized to the Rehab group will have data collected at baseline and then within one week enroll in a pulmonary rehabilitation program. Data will again be collected within one week of completing pulmonary rehabilitation and again six months later.
Wait	Standard pulmonary rehabilitation program	Subjects randomized to the Wait group will have data collected at baseline and wait eight weeks before enrolling in a pulmonary rehabilitation program. Data will again be collected within one week of completing pulmonary rehabilitation and again six months later.

Primary Outcome Measures

Name	Time	Method
Six-minute walk distance	Eight weeks	Distance walked during a standard six-minute walk test.

Secondary Outcome Measures

Name	Time	Method
Six minute walk distance	Six months after completion of pulmonary rehabilitation
dyspnea, fatigue, anxiety, depression, quality of life	Six months after completion of pulmonary rehabilitation

Trial Locations

Locations (1)

National Jewish Health; 🇺🇸 Denver, Colorado, United States