Clinical trial NCT00882817: Pulmonary Rehabilitation in Interstitial Lung Diseases
Official title: Effects of Pulmonary Rehabilitation in Interstitial Lung Diseases: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Interstitial Lung Disease
Keywords: ILD
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2009-04-17
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: changes in six minute walking distance after 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Changes in dyspnea and quality of life scores (MMRC, CRDQ, SGRQ),
timeFrame: 3-6-12 months
measure: Change in peripheral and respiratory muscle force
timeFrame: 3-6-12 months
measure: Change in maximal exercise capacity
timeFrame: 3-6-12 months
measure: Change in daily physical activity measured by Sensewear armband
timeFrame: 3-6-12 months
measure: Changes in pulmonary function and blood gases at rest
timeFrame: 3-6-12 months
measure: Change number of disease-related hospitalizations and survival
timeFrame: 3-6-12 months
measure: Change in functional exercise capacity measured by the 6 minute walking distance
timeFrame: 12 months
measure: To evaluate feasibility and safety of pulmonary rehabilitation in interstitial lung disease
timeFrame: 6 months
measure: Changes in six minute walking distance
timeFrame: at 3, 12 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Katholieke Universiteit Leuven
state: Flanders
Study officials:
affiliation: KU Leuven
name: Silvia Pérez-Bogerd, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven
name: Wim Janssens, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven
name: Wim Wuyts, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.