Physical Activities in Daily Life After Lung Transplantation
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Leuven, Belgium, B-3000
- University Hospital Leuven
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Recipients of single or double lung transplants
Exclusion Criteria:
- Recipients of multiple organ transplants
- Patients scheduled for retransplantation
- Patients not leaving hospital within 6 weeks after surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Rehabilitation + Lifestyle Counseling
Multicomponent Pulmonary Rehabilitation Program 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.
Other Names:
|
|
Active Comparator: Lifestyle 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Participation in Physical Activities in Daily Life
Time Frame: One year
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Health Status (SF-36)
Time Frame: One year
|
One year
|
|
Exercise Capacity
Time Frame: One year
|
One year
|
|
Peripheral Muscle Function
Time Frame: One year
|
One year
|
|
Psychological Functioning
Time Frame: One year
|
One year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- 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
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ML3782
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.