Clinical trial NCT00395889: Physical Activities in Daily Life After Lung Transplantation
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lung Transplantation
Keywords: Lung Transplantation
Physical Activities in Daily Life
Pulmonary Rehabilitation
Functional Status
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Fund for Scientific Research, Flanders, Belgium
name: International Society for Heart and Lung Transplantation
First posted: 2006-11-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Participation in Physical Activities in Daily Life
timeFrame: One year
Secondary outcomes:
measure: Health Status (SF-36)
timeFrame: One year
measure: Exercise Capacity
timeFrame: One year
measure: Peripheral Muscle Function
timeFrame: One year
measure: Psychological Functioning
timeFrame: One year
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Leuven
Study officials:
affiliation: KU-Leuven, Faculty of Movement and Rehabilitation Sciences
name: Daniel Langer, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: KU-Leuven, Faculty of Movement and Rehabilitation Sciences
name: Rik Gosselink, PhD
role: STUDY_CHAIR
affiliation: KU-Leuven, Faculty of Movement and Rehabilitation Sciences
name: Thierry Troosters, PhD
role: STUDY_CHAIR
affiliation: University Hospital Leuven, Respiratory Division
name: Marc Decramer, PhD
role: STUDY_CHAIR
affiliation: University Hospital Leuven, Respiratory Division
name: Geert Verleden, PhD
role: STUDY_CHAIR
affiliation: University Hospital Leuven, Respiratory Division
name: Lieven Dupont, PhD
role: STUDY_CHAIR
References:
citation: Gutierrez-Arias R, Martinez-Zapata MJ, Gaete-Mahn MC, Osorio D, Bustos L, Melo Tanner J, Hidalgo R, Seron P. Exercise training for adult lung transplant recipients. Cochrane Database Syst Rev. 2021 Jul 20;7(7):CD012307. doi: 10.1002/14651858.CD012307.pub2.