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Trial record 5 of 35 for:    interstitial lung disease AND children

Pulmonary Rehabilitation in Interstitial Lung Diseases

This study has been completed.
Information provided by (Responsible Party):
Marc Decramer, Katholieke Universiteit Leuven Identifier:
First received: April 15, 2009
Last updated: July 31, 2013
Last verified: July 2013

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
Intervention Model: Parallel Assignment
Masking: None (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:

Further study details as provided by Marc Decramer, Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • changes in six minute walking distance after 6 months [ Time Frame: 6 months ]
    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 ]
  • Change in peripheral and respiratory muscle force [ Time Frame: 3-6-12 months ]
  • Change in maximal exercise capacity [ Time Frame: 3-6-12 months ]
  • Change in daily physical activity measured by Sensewear armband [ Time Frame: 3-6-12 months ]
  • Changes in pulmonary function and blood gases at rest [ Time Frame: 3-6-12 months ]
  • Change number of disease-related hospitalizations and survival [ Time Frame: 3-6-12 months ]
  • Change in functional exercise capacity measured by the 6 minute walking distance [ Time Frame: 12 months ]
  • To evaluate feasibility and safety of pulmonary rehabilitation in interstitial lung disease [ Time Frame: 6 months ]
  • Changes in six minute walking distance [ Time Frame: at 3, 12 months ]

Enrollment: 60
Study Start Date: April 2009
Study Completion Date: November 2011
Primary Completion Date: October 2011 (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


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00882817

Katholieke Universiteit Leuven
Leuven, Flanders, Belgium, 3000
Sponsors and Collaborators
Katholieke Universiteit Leuven
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

Responsible Party: Marc Decramer, Prof. Dr., Katholieke Universiteit Leuven Identifier: NCT00882817     History of Changes
Other Study ID Numbers: B32220095560
Study First Received: April 15, 2009
Last Updated: July 31, 2013

Keywords provided by Marc Decramer, Katholieke Universiteit Leuven:

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases processed this record on September 21, 2017