Fibrotic Interstitial Lung DiseaseNCT00415272
Pulmonary Rehabilitation in Patients With Fibrotic Interstitial Lung Disease
A study testing Pulmonary Rehabilitation in people with Fibrotic Interstitial Lung Disease, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fibrotic Interstitial Lung Disease
- What is being tested?
- Pulmonary Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento Jul 2007
- Phase
- Interventional
- 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 Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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%
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California at San Francisco
San Francisco, California, 94123
About this study
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.
- Conditions
- Fibrotic Interstitial Lung Disease
- Being tested
- Pulmonary Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary RehabilitationBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2006 (estimated)
- Study completionJul 2007
Why it stopped: Inadequate enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrotic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Investigators
- Harold R Collard, MD, Principal investigator, University of California at San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00415272
- Sponsor's protocol ID
- H52476-29802-01
- Status last verified
- Jan 2008
- First submitted
- 20 Dec 2006
- Last updated
- 15 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Rehabilitation in Patients With Fibrotic Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT00415272
- Acronym / sponsor ID
- H52476-29802-01
- Conditions
- Fibrotic Interstitial Lung Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate enrollment.
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study completion
- Jul 2007 (actual)
- First posted
- 22 Dec 2006 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 Rehabilitation | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Inadequate enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2008.
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Optimizing the Follow-Up Journey in Interstitial Lung Disease: The OPTIMIZE-ILD-2 Trial
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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 at San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Rehabilitation in people with Fibrotic Interstitial Lung Disease, run by University of California, San Francisco at 1 site in United States.
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 4 inclusion and 9 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: stopped early, as of the sponsor's last update on 15 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 was stopped early (reason given: Inadequate enrollment.). Results are not available in the source record.
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.
Where can I read the original study information?
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 15 Jan 2008.