Pulmonary Rehabilitation in Interstitial Lung Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00882817
Recruitment Status : Completed
First Posted : April 17, 2009
Last Update Posted : August 1, 2013
Information provided by (Responsible Party):
Marc Decramer, KU Leuven

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.

Condition or disease Intervention/treatment Phase
Interstitial Lung Disease Other: Pulmonary Rehabilitation Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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
Study Start Date : April 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. changes in six minute walking distance after 6 months [ Time Frame: 6 months ]
    primary outcome of rehabilitation programm

Secondary Outcome Measures :
  1. Changes in dyspnea and quality of life scores (MMRC, CRDQ, SGRQ), [ Time Frame: 3-6-12 months ]
  2. Change in peripheral and respiratory muscle force [ Time Frame: 3-6-12 months ]
  3. Change in maximal exercise capacity [ Time Frame: 3-6-12 months ]
  4. Change in daily physical activity measured by Sensewear armband [ Time Frame: 3-6-12 months ]
  5. Changes in pulmonary function and blood gases at rest [ Time Frame: 3-6-12 months ]
  6. Change number of disease-related hospitalizations and survival [ Time Frame: 3-6-12 months ]
  7. Change in functional exercise capacity measured by the 6 minute walking distance [ Time Frame: 12 months ]
  8. To evaluate feasibility and safety of pulmonary rehabilitation in interstitial lung disease [ Time Frame: 6 months ]
  9. Changes in six minute walking distance [ Time Frame: at 3, 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00882817

Katholieke Universiteit Leuven
Leuven, Flanders, Belgium, 3000
Sponsors and Collaborators
KU Leuven
Principal Investigator: Silvia Pérez-Bogerd, MD KU Leuven
Principal Investigator: Wim Janssens, MD PhD KU Leuven
Principal Investigator: Wim Wuyts, MD PhD KU Leuven

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Marc Decramer, Prof. Dr., KU Leuven Identifier: NCT00882817     History of Changes
Other Study ID Numbers: B32220095560
First Posted: April 17, 2009    Key Record Dates
Last Update Posted: August 1, 2013
Last Verified: July 2013

Keywords provided by Marc Decramer, KU Leuven:

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