Pulmonary Rehabilitation in Interstitial Lung Diseases

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Pulmonary Rehabilitation in Interstitial Lung Diseases: a Prospective Randomized Controlled Trial

Conditions
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Interstitial Lung Disease

Intervention / Treatment
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* Other: Pulmonary Rehabilitation


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Pulmonary Rehabilitation | Other: Pulmonary Rehabilitation<br>* 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.<br>|
| No Intervention: 2<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in six minute walking distance after 6 months | primary outcome of rehabilitation programm | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in dyspnea and quality of life scores (MMRC, CRDQ, SGRQ), |  | 3-6-12 months | 
| Change in peripheral and respiratory muscle force |  | 3-6-12 months | 
| Change in maximal exercise capacity |  | 3-6-12 months | 
| Change in daily physical activity measured by Sensewear armband |  | 3-6-12 months | 
| Changes in pulmonary function and blood gases at rest |  | 3-6-12 months | 
| Change number of disease-related hospitalizations and survival |  | 3-6-12 months | 
| Change in functional exercise capacity measured by the 6 minute walking distance |  | 12 months | 
| To evaluate feasibility and safety of pulmonary rehabilitation in interstitial lung disease |  | 6 months | 
| Changes in six minute walking distance |  | at 3, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ILD