NCT00415272

Brief Summary

Our study aims to investigate the benefits of an outpatient pulmonary rehabilitation program in a population of subjects with fibrotic interstitial lung disease. Our hypothesis is that pulmonary rehabilitation will lead to improvements in quality of life, breathlessness, exercise capacity and pulmonary function in this patient population.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

January 15, 2008

Status Verified

January 1, 2008

First QC Date

December 20, 2006

Last Update Submit

January 11, 2008

Conditions

Fibrotic Interstitial Lung Disease

Interventions

Pulmonary RehabilitationBEHAVIORAL

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Restriction on pulmonary function testing (TLC \<80%, FEV1/FVC ratio \> predicted or DLCO \< 80%)
  • Evidence of fibrosis on high resolution computed tomography of the chest.
  • Fibrosis on surgical lung biopsy if performed
  • Referral for pulmonary rehabilitation

You may not qualify if:

  • Participation in pulmonary rehabilitation in the past 24 months
  • Inability to complete 6 minute walk test or study questionnaires
  • Limitations other than dyspnea (e.g. arthritis) that affect ability to participate in pulmonary rehabilitation
  • Baseline 6 minute walk distance \> 400 meters
  • Planned change in medication treatment for lung disease during the course of pulmonary rehabilitation
  • Ejection fraction known to be \< 25%
  • Contraindications to pulmonary rehabilitation (clinically unstable, uncontrolled arrhythmia or hypertension, symptomatic or uncontrolled hypotension with systolic blood pressure of \< 95, active angina, unexplained syncope or worsening dizziness, limiting orthopedic or neurological disorders, psychiatric impairment that inhibits cooperation in the program)
  • FEV1/FVC \< 65%
  • Unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California at San Francisco

San Francisco, California, 94123, United States

Location

Study Officials

  • Harold R Collard, MD

    University of California at San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 20, 2006

First Posted

December 22, 2006

Study Completion

July 1, 2007

Last Updated

January 15, 2008

Record last verified: 2008-01

Locations

US(1)