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Pulmonary Rehabilitation in Interstitial Lung Diseases

This study is currently recruiting participants.
Verified August 2012 by Katholieke Universiteit Leuven
Sponsor:
Information provided by (Responsible Party):
Marc Decramer, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT00882817
First received: April 15, 2009
Last updated: August 2, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Interstitial Lung Disease
 Other: Pulmonary Rehabilitation
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Pulmonary Rehabilitation in Interstitial Lung Diseases: a Prospective Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • changes in six minute walking distance after 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    primary outcome of rehabilitation programm


Secondary Outcome Measures:
  • Changes in dyspnea and quality of life scores (MMRC, CRDQ, SGRQ), [ Time Frame: 3-6-12 months ] [ Designated as safety issue: No ]
  • Change in peripheral and respiratory muscle force [ Time Frame: 3-6-12 months ] [ Designated as safety issue: No ]
  • Change in maximal exercise capacity [ Time Frame: 3-6-12 months ] [ Designated as safety issue: No ]
  • Change in daily physical activity measured by Sensewear armband [ Time Frame: 3-6-12 months ] [ Designated as safety issue: No ]
  • Changes in pulmonary function and blood gases at rest [ Time Frame: 3-6-12 months ] [ Designated as safety issue: No ]
  • Change number of disease-related hospitalizations and survival [ Time Frame: 3-6-12 months ] [ Designated as safety issue: Yes ]
  • Change in functional exercise capacity measured by the 6 minute walking distance [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To evaluate feasibility and safety of pulmonary rehabilitation in interstitial lung disease [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Changes in six minute walking distance [ Time Frame: at 3, 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2009
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Pulmonary Rehabilitation
 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.
No Intervention: 2

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00882817

Contacts
Contact: Silvia Pérez-Bogerd, MD +32(16)340944 silvia.perezbogerd@uz.kuleuven.ac.be

Locations
Belgium
Katholieke Universiteit Leuven Recruiting
Leuven, Flanders, Belgium, 3000
Principal Investigator: Silvia Pérez-Bogerd, MD            
Principal Investigator: Wim Wuyts, PhD, MD            
Principal Investigator: Wim Janssens, PhD, MD            
Sub-Investigator: Thierry Troosters, PhD            
Sub-Investigator: Marc Decramer, PhD, MD            
Sponsors and Collaborators
Katholieke Universiteit Leuven
Investigators
Principal Investigator: Silvia Pérez-Bogerd, MD Katholieke Universiteit Leuven
Principal Investigator: Wim Janssens, MD PhD Katholieke Universiteit Leuven
Principal Investigator: Wim Wuyts, MD PhD Katholieke Universiteit Leuven
  More Information

No publications provided

Responsible Party: Marc Decramer, Prof. Dr., Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT00882817     History of Changes
Other Study ID Numbers: B32220095560, S1490
Study First Received: April 15, 2009
Last Updated: August 2, 2012
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Keywords provided by Katholieke Universiteit Leuven:
ILD

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Fibrosis
Lung Diseases, Interstitial
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013