Back to resultsPulmonary Rehabilitation in Interstitial Lung Diseases
Primary Purpose
Interstitial Lung Disease
Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Pulmonary Rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Interstitial Lung Disease focused on measuring ILD
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Katholieke Universiteit Leuven
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
1
2
Arm Description
Pulmonary Rehabilitation
Outcomes
Primary Outcome Measures
changes in six minute walking distance after 6 months
primary outcome of rehabilitation programm
Secondary Outcome Measures
Changes in dyspnea and quality of life scores (MMRC, CRDQ, SGRQ),
Change in peripheral and respiratory muscle force
Change in maximal exercise capacity
Change in daily physical activity measured by Sensewear armband
Changes in pulmonary function and blood gases at rest
Change number of disease-related hospitalizations and survival
Change in functional exercise capacity measured by the 6 minute walking distance
To evaluate feasibility and safety of pulmonary rehabilitation in interstitial lung disease
Changes in six minute walking distance
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00882817
Brief Title
Pulmonary Rehabilitation in Interstitial Lung Diseases
Official Title
Effects of Pulmonary Rehabilitation in Interstitial Lung Diseases: a Prospective Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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). 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Lung Disease
Keywords
ILD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Pulmonary Rehabilitation
Arm Title
2
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Pulmonary Rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
changes in six minute walking distance after 6 months
Description
primary outcome of rehabilitation programm
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Changes in dyspnea and quality of life scores (MMRC, CRDQ, SGRQ),
Time Frame
3-6-12 months
Title
Change in peripheral and respiratory muscle force
Time Frame
3-6-12 months
Title
Change in maximal exercise capacity
Time Frame
3-6-12 months
Title
Change in daily physical activity measured by Sensewear armband
Time Frame
3-6-12 months
Title
Changes in pulmonary function and blood gases at rest
Time Frame
3-6-12 months
Title
Change number of disease-related hospitalizations and survival
Time Frame
3-6-12 months
Title
Change in functional exercise capacity measured by the 6 minute walking distance
Time Frame
12 months
Title
To evaluate feasibility and safety of pulmonary rehabilitation in interstitial lung disease
Time Frame
6 months
Title
Changes in six minute walking distance
Time Frame
at 3, 12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvia Pérez-Bogerd, MD
Organizational Affiliation
KU Leuven
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wim Janssens, MD PhD
Organizational Affiliation
KU Leuven
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wim Wuyts, MD PhD
Organizational Affiliation
KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Katholieke Universiteit Leuven
City
Leuven
State/Province
Flanders
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
30236104
Citation
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.
Results Reference
derived
Learn more about this trial
Pulmonary Rehabilitation in Interstitial Lung Diseases
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