Interstitial Lung DiseasePhase 4NCT00882817
Pulmonary Rehabilitation in Interstitial Lung Diseases
A Phase 4 study testing Pulmonary Rehabilitation in people with Interstitial Lung Disease, run by KU Leuven at 1 site in Belgium.
Trial summary
Treatment in interstitial lung diseases (ILD) is frequently ineffective. Pulmonary rehabilitation (PR) is an excellent therapeutic option in another chronic lung diseases such as chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- Pulmonary Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2009to Nov 2011
- Phase
- Phase 4
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of interstitial lung disease according to internationally established criteria
- Dyspnea on exertion
- Stable medical therapy
- Stable clinical condition at inclusion, with no infection or exacerbation in the previous 4 weeks
Who cannot join
- Co-morbidities that do not allow exercise training (unstable angina, recent myocardial infarction or cerebrovascular accident, active cancer, severe orthopedic disorders).
- Life expectancy below 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Pulmonary Rehabilitation in Interstitial Lung Diseases: a Prospective Randomized Controlled Trial
Treatment in interstitial lung diseases (ILD) is frequently ineffective. Pulmonary rehabilitation (PR) is an excellent therapeutic option in another chronic lung diseases such as chronic obstructive pulmonary disease (COPD). This prospective randomized controlled study aims to evaluate the short and long-term effects of PR in patients with ILD. For this purpose, 60 ILD patients will be randomly assigned to a PR or a control group.
The investigators hypothesize that PR will improve exercise capacity, increase muscle force, reduce dyspnea and improve quality of life and daily life activities in ILD patients.
- Conditions
- Interstitial Lung Disease
- Being tested
- Pulmonary Rehabilitation
- Keywords
- ILD
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary RehabilitationOther
The intervention group will perform a 6 month pulmonary rehabilitation program which consists of training, patient education, nutrition counseling and psychosocial support. They will be evaluated with some tests for the study.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Pulmonary Rehabilitation Receives: Other: Pulmonary Rehabilitation |
| 2 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in six minute walking distance after 6 months
primary outcome of rehabilitation programm
Measured: 6 months
Secondary outcomes (9)
Changes in dyspnea and quality of life scores (MMRC, CRDQ, SGRQ),
Measured: 3-6-12 months
Change in peripheral and respiratory muscle force
Measured: 3-6-12 months
Change in maximal exercise capacity
Measured: 3-6-12 months
Change in daily physical activity measured by Sensewear armband
Measured: 3-6-12 months
Changes in pulmonary function and blood gases at rest
Measured: 3-6-12 months
Change number of disease-related hospitalizations and survival
Measured: 3-6-12 months
Change in functional exercise capacity measured by the 6 minute walking distance
Measured: 12 months
To evaluate feasibility and safety of pulmonary rehabilitation in interstitial lung disease
Measured: 6 months
Changes in six minute walking distance
Measured: at 3, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionOct 2011
- Study completionNov 2011
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 KU LeuvenThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Decramer, KU Leuven
- Investigators
- Silvia Pérez-Bogerd, MD, Principal investigator, KU LeuvenWim Janssens, MD PhD, Principal investigator, KU LeuvenWim Wuyts, MD PhD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00882817
- Sponsor's protocol ID
- B32220095560
- Other IDs
- S1490
- Status last verified
- Jul 2013
- First submitted
- 15 Apr 2009
- Last updated
- 1 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Perez-Bogerd S, Wuyts W, Barbier V, Demeyer H, Van Muylem A, Janssens W, Troosters T. Short and long-term effects of pulmonary rehabilitation in interstitial lung diseases: a randomised controlled trial. Respir Res. 2018 Sep 20;19(1):182. doi: 10.1186/s12931-018-0884-y.
PubMed 30236104
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pulmonary Rehabilitation in Interstitial Lung Diseases: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00882817
- Acronym / sponsor ID
- B32220095560
- Conditions
- Interstitial Lung Disease
- Keywords
- ILD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 17 Apr 2009 (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.
Treatment in interstitial lung diseases (ILD) is frequently ineffective. Pulmonary rehabilitation (PR) is an excellent therapeutic option in another chronic lung diseases such as chronic obstructive pulmonary disease (COPD). This prospective randomized controlled study aims to evaluate the short and long-term effects of PR in patients with ILD. For this purpose, 60 ILD patients will be randomly assigned to a PR or a control group.
The investigators hypothesize that PR will improve exercise capacity, increase muscle force, reduce dyspnea and improve quality of life and daily life activities in ILD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Pulmonary RehabilitationPulmonary Rehabilitation |
| 2 | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of interstitial lung disease according to internationally established criteria
- Dyspnea on exertion
- Stable medical therapy
- Stable clinical condition at inclusion, with no infection or exacerbation in the previous 4 weeks
Key exclusion criteria (2 listed)
- Co-morbidities that do not allow exercise training (unstable angina, recent myocardial infarction or cerebrovascular accident, active cancer, severe orthopedic disorders).
- Life expectancy below 3 months
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 RehabilitationThe intervention group will perform a 6 month pulmonary rehabilitation program which consists of training, patient education, nutrition counseling and psychosocial support. They will be evaluated with some tests for the study. | Other | 1 |
Primary outcome
changes in six minute walking distance after 6 months
Time frame: 6 months
primary outcome of rehabilitation programm
9 secondary outcomes
Changes in dyspnea and quality of life scores (MMRC, CRDQ, SGRQ),
Time frame: 3-6-12 months
Change in peripheral and respiratory muscle force
Time frame: 3-6-12 months
Change in maximal exercise capacity
Time frame: 3-6-12 months
Change in daily physical activity measured by Sensewear armband
Time frame: 3-6-12 months
Changes in pulmonary function and blood gases at rest
Time frame: 3-6-12 months
Change number of disease-related hospitalizations and survival
Time frame: 3-6-12 months
Change in functional exercise capacity measured by the 6 minute walking distance
Time frame: 12 months
To evaluate feasibility and safety of pulmonary rehabilitation in interstitial lung disease
Time frame: 6 months
Changes in six minute walking distance
Time frame: at 3, 12 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 1 Aug 2013.
- Derived from this study: PubMed 30236104Perez-Bogerd S, Wuyts W, Barbier V, Demeyer H, Van Muylem A, Janssens W, Troosters T. Short and long-term effects of pulmonary rehabilitation in interstitial lung diseases: a randomised controlled trial. Respir Res. 2018 Sep 20;19(1):182. doi: 10.1186/s12931-018-0884-y.
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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.
Silvia Pérez-Bogerd, MD principal investigator
KU Leuven
Wim Janssens, MD PhD principal investigator
KU Leuven
Wim Wuyts, MD PhD principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pulmonary Rehabilitation in people with Interstitial Lung Disease, run by KU Leuven at 1 site in Belgium.
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 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 1 Aug 2013. 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 Belgium. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
changes in six minute walking distance after 6 months (time frame: 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 NCT00882817, 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 1 Aug 2013.