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OpenTrials
Completed

NCT Number: NCT00882817

Pulmonary Rehabilitation in Interstitial Lung Diseases

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.

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Key information

Conditions

Interstitial Lung Disease Lung Diseases Lung Diseases, Interstitial Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Katholieke Universiteit Leuven

Leuven, Flanders, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulmonary Rehabilitation

Other

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.

Primary outcomes

  1. changes in six minute walking distance after 6 months

    Time frame: 6 months

    primary outcome of rehabilitation programm

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 17, 2009
Registry last updated
Aug 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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