Beneficial Effects of Pulmonary Rehabilitation for Idiopathic Pulmonary Fibrosis

NCT01107028 | Completed

• 2 other identifiers: NJ230K23HL092227-01A2
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Idiopathic pulmonary fibrosis; Dyspnea; Functional capacity; Quality of life

Outcome Measures

Primary Outcomes (1)

• Six-minute walk distance

  Distance walked during a standard six-minute walk test.

  Eight weeks

Secondary Outcomes (3)

• 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

Study Arms (2)

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

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

Interventions

Standard pulmonary rehabilitation program OTHER

At the assigned time, subjects will complete a six-week, outpatient pulmonary rehabilitation program at any local center that has such a program.

Rehab; Wait

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Jewish Health: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

Location

Related Publications (1)

• 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.

  PMID: 18848771 BACKGROUND

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Dyspnea

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeffrey J. Swigris, DO, MS

  National Jewish Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2010
• First Posted: April 20, 2010
• Study Start: February 1, 2010
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

US (1)