NCT01055730

Brief Summary

The purpose of this study is to determine if pulmonary rehabilitation has any effect on breathlessness, quality of life, physical function and depression in persons with interstitial lung disease.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2010

Typical duration for all trials

Geographic Reach
2 countries

6 active sites

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

First Submitted

Initial submission to the registry

January 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 26, 2010

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

November 21, 2013

Status Verified

November 1, 2013

Enrollment Period

2.9 years

First QC Date

January 25, 2010

Last Update Submit

November 19, 2013

Conditions

Interstitial Lung Disease

Keywords

Pulmonary rehabilitationExercise therapyInterstitial lung diseasePulmonary fibrosisMobility limitationDyspneaMental health

Outcome Measures

Primary Outcomes (2)

  • 6-minute walk distance

    Immediately following completion of pulmonary rehabilitation and 6 months following the start of pulmonary rehabilitation

  • Quality of life

    Immediately following completion of pulmonary rehabilitation and 6 months following the start of pulmonary rehabilitation

Secondary Outcomes (2)

  • Dyspnea

    Immediately following completion of pulmonary rehabilitation and 6 months following the start of pulmonary rehabilitation

  • Depression

    Immediately following completion of pulmonary rehabilitation and 6 months following the start of pulmonary rehabilitation

Study Arms (1)

Pulmonary rehabilitation

Other: Pulmonary rehabilitation

Interventions

Pulmonary rehabilitationOTHER

Structured education and supervised exercise program, lasting between 6 and 9 weeks.

Pulmonary rehabilitation

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any patient with interstitial lung disease who is referred to a participating pulmonary rehabilitation program. These patients typically have exercise limitation and dyspnea, but still possess the ability to perform some exercise.

You may qualify if:

  • Adults (\> 18 years old) with a diagnosis of ILD who are referred to a participating PR program

You may not qualify if:

  • Inability to provide informed consent
  • Inability to read and write English
  • Any other medical condition that significantly limits the subject's ability to perform the functional measures
  • Emphysema / Chronic bronchitis (FEV1 / FVC ratio \< 60%)
  • Previous pulmonary rehabilitation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

John Muir Health

Concord, California, 94520, United States

Location

Seton Pulmonary & Cardiac Rehabilitation

Daly City, California, 94015, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06520-8057, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

University of British Columbia

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Related Publications (1)

  • Ryerson CJ, Cayou C, Topp F, Hilling L, Camp PG, Wilcox PG, Khalil N, Collard HR, Garvey C. Pulmonary rehabilitation improves long-term outcomes in interstitial lung disease: a prospective cohort study. Respir Med. 2014 Jan;108(1):203-10. doi: 10.1016/j.rmed.2013.11.016. Epub 2013 Dec 4.

    PMID: 24332409DERIVED

MeSH Terms

Conditions

Lung Diseases, InterstitialPulmonary FibrosisMobility LimitationDyspneaPsychological Well-Being

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsRespiration DisordersSigns and Symptoms, RespiratoryPersonal SatisfactionBehavior

Study Officials

  • Harold R Collard, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Christopher J Ryerson, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Chris Garvey, FNP

    Seton Pulmonary & Cardiac Rehabilitation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2010

First Posted

January 26, 2010

Study Start

February 1, 2010

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

November 21, 2013

Record last verified: 2013-11

Locations

CA(1)US(5)