Physical Activities in Daily Life After Lung Transplantation
Condition: Lung Transplantation
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): Rehabilitation including structured exercise training; Physical Activity Counseling
Intervention type(s): Procedure; Procedure
Intervention description(s): 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.; 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.
Other intervention name(s): Physical Activity Counseling; Pulmonary Rehabilitation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lung Transplantation; Physical Activities in Daily Life; Pulmonary Rehabilitation; Functional Status