Physical Activities in Daily Life After Lung Transplantation

Phase 1

Completed

• Conditions: Lung Transplantation
• Interventions: Procedure: Rehabilitation including structured exercise training; Procedure: Physical Activity Counseling

• Registration Number: NCT00395889
• Lead Sponsor: KU Leuven

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.

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-11-03
• Study First Submitted QC: 2006-11-03
• Study First Posted: 2006-11-06
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-18
• Last Update Posted: 2011-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rehabilitation + Lifestyle Counseling	Rehabilitation including structured exercise training	Multicomponent Pulmonary Rehabilitation Program including structured exercise training
Lifestyle Counseling	Physical Activity Counseling	-

Primary Outcome Measures

Name	Time	Method
Participation in Physical Activities in Daily Life	One year

Secondary Outcome Measures

Name	Time	Method
Health Status (SF-36)	One year
Exercise Capacity	One year
Peripheral Muscle Function	One year
Psychological Functioning	One year

Trial Locations

Locations (1)

University Hospital Leuven; 🇧🇪 Leuven, Belgium