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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
Sponsor:
Collaborators:
Fund for Scientific Research, Flanders, Belgium
International Society for Heart and Lung Transplantation
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Lung Transplantation Procedure: Rehabilitation including structured exercise training Procedure: Physical Activity Counseling Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other Names:
  • Physical Activity Counseling
  • Pulmonary Rehabilitation

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.




Primary Outcome Measures :
  1. Participation in Physical Activities in Daily Life [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Health Status (SF-36) [ Time Frame: One year ]
  2. Exercise Capacity [ Time Frame: One year ]
  3. Peripheral Muscle Function [ Time Frame: One year ]
  4. Psychological Functioning [ Time Frame: One year ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Belgium
University Hospital Leuven
Leuven, Belgium, B-3000
Sponsors and Collaborators
KU Leuven
Fund for Scientific Research, Flanders, Belgium
International Society for Heart and Lung Transplantation
Investigators
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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

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Responsible Party: Daniel Langer, KU Leuven
ClinicalTrials.gov Identifier: NCT00395889     History of Changes
Other Study ID Numbers: ML3782
First Posted: November 6, 2006    Key Record Dates
Last Update Posted: February 21, 2011
Last Verified: February 2011
Keywords provided by KU Leuven:
Lung Transplantation
Physical Activities in Daily Life
Pulmonary Rehabilitation
Functional Status