Pulmonary Rehabilitation in Interstitial Lung Diseases

Interstitial Lung Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00882817
• Other study ID #: B32220095560
• Secondary ID: S1490
• Status: Completed
• Phase: Phase 4
• First received: April 15, 2009
• Last updated: July 31, 2013
• Start date: April 2009
• Est. completion date: November 2011

Study information

• Verified date: July 2013
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

Other:
• Pulmonary Rehabilitation
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.

Locations

Country	Name	City	State
Belgium	Katholieke Universiteit Leuven	Leuven	Flanders

Sponsors (1)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in six minute walking distance after 6 months	primary outcome of rehabilitation programm	6 months	No
Secondary	Changes in dyspnea and quality of life scores (MMRC, CRDQ, SGRQ),		3-6-12 months	No
Secondary	Change in peripheral and respiratory muscle force		3-6-12 months	No
Secondary	Change in maximal exercise capacity		3-6-12 months	No
Secondary	Change in daily physical activity measured by Sensewear armband		3-6-12 months	No
Secondary	Changes in pulmonary function and blood gases at rest		3-6-12 months	No
Secondary	Change number of disease-related hospitalizations and survival		3-6-12 months	Yes
Secondary	Change in functional exercise capacity measured by the 6 minute walking distance		12 months	No
Secondary	To evaluate feasibility and safety of pulmonary rehabilitation in interstitial lung disease		6 months	Yes
Secondary	Changes in six minute walking distance		at 3, 12 months	No