Beneficial Effects of Pulmonary Rehabilitation for Idiopathic Pulmonary Fibrosis

Pulmonary Rehabilitation for Idiopathic Pulmonary Fibrosis

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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Other: Standard pulmonary rehabilitation program

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 Type: Observational
• Enrollment (Actual): 41

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80206
      • National Jewish Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Idiopathic pulmonary fibrosis, as defined by the American Thoracic Society Consensus Guidelines

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Rehab; 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.	Other: Standard pulmonary rehabilitation program; At the assigned time, subjects will complete a six-week, outpatient pulmonary rehabilitation program at any local center that has such a program.
Wait; 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.	Other: Standard pulmonary rehabilitation program; At the assigned time, subjects will complete a six-week, outpatient pulmonary rehabilitation program at any local center that has such a program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six-minute walk distance	Distance walked during a standard six-minute walk test.	Eight weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
dyspnea, fatigue, anxiety, depression, quality of life	Eight weeks
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

Collaborators and Investigators

• Sponsor: National Jewish Health
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Jeffrey J. Swigris, DO, MS, National Jewish Health

Publications and helpful links

General Publications

• Swigris JJ, Brown KK, Make BJ, Wamboldt FS. Pulmonary rehabilitation in idiopathic pulmonary fibrosis: a call for continued investigation. Respir Med. 2008 Dec;102(12):1675-80. doi: 10.1016/j.rmed.2008.08.014. Epub 2008 Oct 10.

Helpful Links

• National Jewish website information for this study

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: April 16, 2010
• First Submitted That Met QC Criteria: April 19, 2010
• First Posted (Estimate): April 20, 2010

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 19, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Quality of life; Idiopathic pulmonary fibrosis; Dyspnea; Functional capacity
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: NJ230; K23HL092227-01A2 (U.S. NIH Grant/Contract)