Beneficial Effects of Pulmonary Rehabilitation for Idiopathic Pulmonary Fibrosis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by:
National Jewish Health
ClinicalTrials.gov Identifier:
NCT01107028
First received: April 16, 2010
Last updated: November 11, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Idiopathic Pulmonary Fibrosis
Other: Standard pulmonary rehabilitation program

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pulmonary Rehabilitation for Idiopathic Pulmonary Fibrosis

Resource links provided by NLM:


Further study details as provided by National Jewish Health:

Primary Outcome Measures:
  • Six-minute walk distance [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]
    Distance walked during a standard six-minute walk test.


Secondary Outcome Measures:
  • dyspnea, fatigue, anxiety, depression, quality of life [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]
  • Six minute walk distance [ Time Frame: Six months after completion of pulmonary rehabilitation ] [ Designated as safety issue: No ]
  • dyspnea, fatigue, anxiety, depression, quality of life [ Time Frame: Six months after completion of pulmonary rehabilitation ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: February 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01107028

Locations
United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
Sponsors and Collaborators
National Jewish Health
Investigators
Principal Investigator: Jeffrey J. Swigris, DO, MS National Jewish Health
  More Information

Additional Information:
Publications:
Responsible Party: Jeff Swigris, DO, MS, Assistant Professor of Medicine, National Jewish Health, Denver, CO
ClinicalTrials.gov Identifier: NCT01107028     History of Changes
Other Study ID Numbers: NJ230, K23HL092227-01A2
Study First Received: April 16, 2010
Last Updated: November 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by National Jewish Health:
Idiopathic pulmonary fibrosis
Dyspnea
Functional capacity
Quality of life

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial

ClinicalTrials.gov processed this record on August 21, 2014