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Sponsors and Collaborators: |
Katholieke Universiteit Leuven Fund for Scientific Research, Flanders, Belgium International Society for Heart and Lung Transplantation |
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Information provided by: | Katholieke Universiteit Leuven |
ClinicalTrials.gov Identifier: | NCT00395889 |
The purpose of this study is to compare participation in physical activities in daily life and functional outcomes of lung transplant recipients attending a six-month multicomponent rehabilitation program including exercise training against others receiving only instructions on how to increase their participation in physical activities in daily life.
Condition | Intervention | Phase |
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Lung Transplantation |
Procedure: Multicomponent Pulmonary Rehabilitation Program including structured exercise training Procedure: Physical Activity Counseling |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Effects of a 6-Month Outpatient Rehabilitation Program Including Structured Exercise Training on Participation in Physical Activities in Daily Life in Lung Transplant Recipients |
Estimated Enrollment: | 60 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | November 2010 |
At present it is not clear whether it is necessary for lung transplant recipients to participate in a rehabilitation program including structured exercise training. Observations from available studies suggest that exercise capacity and health status improve following transplantation but remain impaired when compared with values of age-matched reference groups. No differences were found between participants of rehabilitation programs and patients engaging in usual daily activities. One should be cautious however to draw definite conclusions from these findings since they rest solely on results of cross-sectional investigations or single group studies. No information on functional outcomes such as participation in physical activities in daily life is currently available in lung transplant recipients. In order to answer the question if it is necessary for lung transplant recipients to participate in an outpatient rehabilitation program including structured exercise training it is our purpose to conduct a randomized clinical trial to investigate the effects of pulmonary rehabilitation after transplantation.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Daniel Langer, MSc | +32-16-330192 | daniel.langer@faber.kuleuven.be |
Belgium | |
University Hospital Leuven | Recruiting |
Leuven, Belgium, B-3000 | |
Principal Investigator: Daniel Langer, MSc |
Principal Investigator: | Daniel Langer, MSc | KU-Leuven, Faculty of Movement and Rehabilitation Sciences |
Study Chair: | Rik Gosselink, PhD | KU-Leuven, Faculty of Movement and Rehabilitation Sciences |
Study Chair: | Thierry Troosters, PhD | KU-Leuven, Faculty of Movement and Rehabilitation Sciences |
Study Chair: | Marc Decramer, PhD | University Hospital Leuven, Respiratory Division |
Study Chair: | Geert Verleden, PhD | University Hospital Leuven, Respiratory Division |
Study Chair: | Lieven Dupont, PhD | University Hospital Leuven, Respiratory Division |
Study ID Numbers: | ML3782 |
Study First Received: | November 3, 2006 |
Last Updated: | October 30, 2007 |
ClinicalTrials.gov Identifier: | NCT00395889 History of Changes |
Health Authority: | Belgium: Institutional Review Board |
Lung Transplantation Physical Activities in Daily Life Pulmonary Rehabilitation Functional Status |