Physical Activities in Daily Life After Lung Transplantation
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|ClinicalTrials.gov Identifier: NCT00395889|
Recruitment Status : Completed
First Posted : November 6, 2006
Last Update Posted : February 21, 2011
|Condition or disease||Intervention/treatment||Phase|
|Lung Transplantation||Procedure: Rehabilitation including structured exercise training Procedure: Physical Activity Counseling||Phase 1|
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.
- Interventions: Both groups will receive counseling to engage in regular physical activity. Patients in the intervention group will additionally follow a standardized outpatient pulmonary rehabilitation program for 6 months starting immediately after discharge from hospital.
- Hypothesis: Our alternative hypothesis is that intensive post transplant rehabilitation does enhance improvements in functional status and participation in physical activities in daily life after transplantation.
- Outcomes: Participation in physical activities in daily life will be the primary outcome. Physical component summary scale of the SF-36, exercise capacity and peripheral muscle function will be secondary outcomes. Outcomes will be assessed on discharge from the hospital and again three, six and twelve months after discharge.
- Treatment failure: Patients in the control group receiving only counseling will be allowed to discontinue the assigned treatment and will receive respiratory rehabilitation including exercise training if functional outcomes do not improve or participation in physical activities in daily life does not increase within the first three months of the intervention period. The treatment groups will be compared both as randomized (according to intention to treat) and with crossover cases excluded.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||November 2010|
Experimental: Rehabilitation + Lifestyle Counseling
Multicomponent Pulmonary Rehabilitation Program including structured exercise training
Procedure: Rehabilitation including structured exercise training
Rehabilitation of at least 8 weeks, for at least twice/week. This group will also receive the exercise counseling as a part of the rehabilitation program.
|Active Comparator: Lifestyle Counseling||
Procedure: Physical Activity Counseling
Six exercise counseling sessions will be carried out during a 6-month period. This group will only receive the counseling and no formal structured exercise training sessions.
- Participation in Physical Activities in Daily Life [ Time Frame: One year ]
- Health Status (SF-36) [ Time Frame: One year ]
- Exercise Capacity [ Time Frame: One year ]
- Peripheral Muscle Function [ Time Frame: One year ]
- Psychological Functioning [ Time Frame: One year ]
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 ClinicalTrials.gov identifier (NCT number): NCT00395889
|University Hospital Leuven|
|Leuven, Belgium, B-3000|
|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|