Interstitial Lung DiseasePR-ILDNCT01055730
The Impact of Pulmonary Rehabilitation in Interstitial Lung Disease
An observational study of Interstitial Lung Disease, run by University of California, San Francisco at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- Pulmonary rehabilitation
- How many people
- 54 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Feb 2010to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adults (> 18 years old) with a diagnosis of ILD who are referred to a participating PR program
Who cannot join
- 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
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
John Muir Health
Concord, California, 94520
Seton Pulmonary & Cardiac Rehabilitation
Daly City, California, 94015
Duke University Medical Center
Durham, North Carolina, 27710
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Yale University School of Medicine
New Haven, Connecticut, 06520-8057
Canada1 site
University of British Columbia
Vancouver, British Columbia, V6Z 1Y6
About this study
Official title: The Impact of Pulmonary Rehabilitation in Interstitial Lung Disease: A Prospective Cohort Study
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.
- Conditions
- Interstitial Lung Disease
- Being tested
- Pulmonary rehabilitation
- Keywords
- Pulmonary rehabilitation, Exercise therapy, Interstitial lung disease, Pulmonary fibrosis, Mobility limitation, Dyspnea, Mental health
- Medical subject headings
- Lung Diseases, Interstitial, Pulmonary Fibrosis, Mobility Limitation, Dyspnea, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary rehabilitationOther
Structured education and supervised exercise program, lasting between 6 and 9 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary rehabilitation | Not described Receives: Other: Pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk distance
Measured: Immediately following completion of pulmonary rehabilitation and 6 months following the start of pulmonary rehabilitation
Quality of life
Measured: Immediately following completion of pulmonary rehabilitation and 6 months following the start of pulmonary rehabilitation
Secondary outcomes (2)
Dyspnea
Measured: Immediately following completion of pulmonary rehabilitation and 6 months following the start of pulmonary rehabilitation
Depression
Measured: Immediately following completion of pulmonary rehabilitation and 6 months following the start of pulmonary rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harold R Collard, MD, Principal investigator, University of California, San FranciscoChristopher J Ryerson, MD, Principal investigator, University of California, San FranciscoChris Garvey, FNP, Principal investigator, Seton Pulmonary & Cardiac Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01055730
- Sponsor's protocol ID
- PR-ILD
- Acronym
- PR-ILD
- Status last verified
- Nov 2013
- First submitted
- 25 Jan 2010
- Last updated
- 21 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24332409
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Pulmonary Rehabilitation in Interstitial Lung Disease: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT01055730
- Acronym / sponsor ID
- PR-ILD / PR-ILD
- Conditions
- Interstitial Lung Disease
- Keywords
- Pulmonary rehabilitation, Exercise therapy, Interstitial lung disease, Pulmonary fibrosis, Mobility limitation, Dyspnea, Mental health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 26 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary rehabilitation | – | Other: Pulmonary rehabilitation |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Adults (> 18 years old) with a diagnosis of ILD who are referred to a participating PR program
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary rehabilitationStructured education and supervised exercise program, lasting between 6 and 9 weeks. | Other | Pulmonary rehabilitation |
Primary outcome
6-minute walk distance
Time frame: Immediately following completion of pulmonary rehabilitation and 6 months following the start of pulmonary rehabilitation
Quality of life
Time frame: Immediately following completion of pulmonary rehabilitation and 6 months following the start of pulmonary rehabilitation
2 secondary outcomes
Dyspnea
Time frame: Immediately following completion of pulmonary rehabilitation and 6 months following the start of pulmonary rehabilitation
Depression
Time frame: Immediately following completion of pulmonary rehabilitation and 6 months following the start of pulmonary rehabilitation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2013.
- Derived from this study: PubMed 24332409Ryerson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harold R Collard, MD principal investigator
University of California, San Francisco
Christopher J Ryerson, MD principal investigator
University of California, San Francisco
Chris Garvey, FNP principal investigator
Seton Pulmonary & Cardiac Rehabilitation
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Disease, run by University of California, San Francisco at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute walk distance (time frame: Immediately following completion of pulmonary rehabilitation and 6 months following the start of pulmonary rehabilitation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01055730, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2013.