Idiopathic Pulmonary FibrosisNCT00692796
Pulmonary Rehabilitation for Idiopathic Pulmonary Fibrosis
A study testing Pulmonary rehabilitation in people with Idiopathic Pulmonary Fibrosis, run by National Jewish Health at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of Pulmonary Rehabilitation (PR) on shortness of breath, exercise capacity, symptom control, mental health, cognitive function, and quality of life in patients with Idiopathic Pulmonary Fibrosis (IPF). Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Pulmonary rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Mar 2010
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40 years or older
- Diagnosis of IPF according to American Thoracic Society criteria
Who cannot join
- Patients who have completed a PR program within the last two years
- Patients with unstable medical conditions that would make PR unsafe
Trial locations and contacts
1 site in 1 country.
United States1 site
National Jewish Medical and Research Center
Denver, Colorado, 80206
About this study
The purpose of this study is to determine the effects of Pulmonary Rehabilitation (PR) on shortness of breath, exercise capacity, symptom control, mental health, cognitive function, and quality of life in patients with Idiopathic Pulmonary Fibrosis (IPF). Pulmonary rehabilitation has already been shown to benefit patients with other chronic respiratory diseases, such as chronic obstructive pulmonary disease (COPD). We believe that pulmonary rehabilitation will benefit patients with IPF as well.
Read the detailed description
The goals of this project are to assess the effect of PR on a number of important outcomes in patients with IPF. Once enrolled in the study, subjects will complete a battery of questionnaires and tests that assess symptoms, quality of life, cognition, and mental health, and then subjects will complete a six week outpatient PR program (at National Jewish Medical and Research Center or other PR programs). Subjects will complete the same battery of questionnaires and tests immediately after completion of the PR program and again six months later.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Pulmonary rehabilitation
- Keywords
- Pulmonary fibrosis, Pulmonary rehabilitation, Dyspnea, Quality of life
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary rehabilitationOther
Pulmonary rehabilitation is a multi-disciplinary program that includes exercise training, disease education, psychosocial education (e.g., stress management, coping with chronic illness) and nutrition education.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Other: Pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise capacity
Measured: 6 weeks and again at 6 months
Secondary outcomes (5)
Cognition
Measured: 6 weeks and again at 6 months
Quality of life
Measured: 6 weeks and again at 6 months
Fatigue
Measured: 6 weeks and again at 6 months
Anxiety
Measured: 6 weeks and again at 6 months
Depression
Measured: 6 weeks and again at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startApr 2008
- Primary completionMar 2010
- Study completionMar 2010
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 Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Collaborators
- Mordecai Palliative Care Research Fund
- Investigators
- Jeff Swigris, DO, MS, Principal investigator, National Jewish Medical and Research Center (Jeffrey J. Swigris, DO, MS; Assistant Professor of Medicine)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00692796
- Sponsor's protocol ID
- NJMRC HS 1603 substudy
- Status last verified
- Mar 2017
- First submitted
- 4 Jun 2008
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Swigris JJ, Fairclough DL, Morrison M, Make B, Kozora E, Brown KK, Wamboldt FS. Benefits of pulmonary rehabilitation in idiopathic pulmonary fibrosis. Respir Care. 2011 Jun;56(6):783-9. doi: 10.4187/respcare.00939. Epub 2011 Feb 11.
PubMed 21333082
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Rehabilitation for Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT00692796
- Acronym / sponsor ID
- NJMRC HS 1603 substudy
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Pulmonary fibrosis, Pulmonary rehabilitation, Dyspnea, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Collaborators
- Mordecai Palliative Care Research Fund
- Study start
- Apr 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 6 Jun 2008 (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 the effects of Pulmonary Rehabilitation (PR) on shortness of breath, exercise capacity, symptom control, mental health, cognitive function, and quality of life in patients with Idiopathic Pulmonary Fibrosis (IPF). Pulmonary rehabilitation has already been shown to benefit patients with other chronic respiratory diseases, such as chronic obstructive pulmonary disease (COPD). We believe that pulmonary rehabilitation will benefit patients with IPF as well.
Detailed description
The goals of this project are to assess the effect of PR on a number of important outcomes in patients with IPF. Once enrolled in the study, subjects will complete a battery of questionnaires and tests that assess symptoms, quality of life, cognition, and mental health, and then subjects will complete a six week outpatient PR program (at National Jewish Medical and Research Center or other PR programs). Subjects will complete the same battery of questionnaires and tests immediately after completion of the PR program and again six months later.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Pulmonary rehabilitation |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 40 years or older
- Diagnosis of IPF according to American Thoracic Society criteria
Key exclusion criteria (2 listed)
- Patients who have completed a PR program within the last two years
- Patients with unstable medical conditions that would make PR unsafe
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 rehabilitationPulmonary rehabilitation is a multi-disciplinary program that includes exercise training, disease education, psychosocial education (e.g., stress management, coping with chronic illness) and nutrition education. | Other | 1 |
Primary outcome
Exercise capacity
Time frame: 6 weeks and again at 6 months
5 secondary outcomes
Cognition
Time frame: 6 weeks and again at 6 months
Quality of life
Time frame: 6 weeks and again at 6 months
Fatigue
Time frame: 6 weeks and again at 6 months
Anxiety
Time frame: 6 weeks and again at 6 months
Depression
Time frame: 6 weeks and again at 6 months
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 29 Mar 2017.
- Derived from this study: PubMed 21333082Swigris JJ, Fairclough DL, Morrison M, Make B, Kozora E, Brown KK, Wamboldt FS. Benefits of pulmonary rehabilitation in idiopathic pulmonary fibrosis. Respir Care. 2011 Jun;56(6):783-9. doi: 10.4187/respcare.00939. Epub 2011 Feb 11.
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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.
Jeff Swigris, DO, MS principal investigator
National Jewish Medical and Research Center (Jeffrey J. Swigris, DO, MS; Assistant Professor of Medicine)
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 Idiopathic Pulmonary Fibrosis, run by National Jewish Health 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 2 inclusion and 2 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 29 Mar 2017. 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 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?
Exercise capacity (time frame: 6 weeks and again at 6 months). 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 NCT00692796, 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 29 Mar 2017.