NCT00692796

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2017

Enrollment Period

1.9 years

First QC Date

June 4, 2008

Last Update Submit

March 27, 2017

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Pulmonary fibrosisPulmonary rehabilitationDyspneaQuality of life

Outcome Measures

Primary Outcomes (1)

  • Exercise capacity

    6 weeks and again at 6 months

Secondary Outcomes (5)

  • Cognition

    6 weeks and again at 6 months

  • Quality of life

    6 weeks and again at 6 months

  • Fatigue

    6 weeks and again at 6 months

  • Anxiety

    6 weeks and again at 6 months

  • Depression

    6 weeks and again at 6 months

Study Arms (1)

1

EXPERIMENTAL
Other: Pulmonary rehabilitation

Interventions

Pulmonary rehabilitationOTHER

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.

1

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 40 years or older
  • Diagnosis of IPF according to American Thoracic Society criteria

You may not qualify if:

  • Patients who have completed a PR program within the last two years
  • Patients with unstable medical conditions that would make PR unsafe

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Jewish Medical and Research Center

Denver, Colorado, 80206, United States

Location

Related Publications (1)

  • Swigris JJ, Fairclough DL, Morrison M, Make B, Kozora E, Brown KK, Wamboldt FS. Benefits of pulmonary rehabilitation in idiopathic pulmonary fibrosis. Respir Care. 2011 Jun;56(6):783-9. doi: 10.4187/respcare.00939. Epub 2011 Feb 11.

    PMID: 21333082DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary FibrosisPulmonary FibrosisDyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • Jeff Swigris, DO, MS

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 4, 2008

First Posted

June 6, 2008

Study Start

April 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

March 29, 2017

Record last verified: 2017-03

Locations

US(1)