Physical Activities in Daily Life After Lung Transplantation

Lung Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00395889
• Other study ID #: ML3782
• Status: Completed
• Phase: Phase 1
• First received: November 3, 2006
• Last updated: February 18, 2011
• Start date: November 2006
• Est. completion date: November 2010

Study information

• Verified date: February 2011
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Transplantation

Intervention

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.
• 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.

Locations

Country	Name	City	State
Belgium	University Hospital Leuven	Leuven

Sponsors (3)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven	Fund for Scientific Research, Flanders, Belgium, International Society for Heart and Lung Transplantation

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participation in Physical Activities in Daily Life		One year	No
Secondary	Health Status (SF-36)		One year	No
Secondary	Exercise Capacity		One year	No
Secondary	Peripheral Muscle Function		One year	No
Secondary	Psychological Functioning		One year	No