Effects of a Whole Body Vibration Training in Patients After Lung Transplantation

Study Overview
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Brief Summary
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Pulmonary rehabilitation has been established as an evidence-based and recommended therapy in patients following lung transplantation. Exercise training has been shown to be a cornerstone of an inpatient rehabilitation program to reduce muscle dysfunction and improve exercise performance. In our study we will investigate the benefit of a whole body vibration training in addition to a standard pulmonary rehabilitation program that includes endurance and strength training. We will include a total of 140 patients (70 patients < 1 year after lung Transplantation and 70 patients > 1 year after lung Transplantation). Our hypothesis is that an addtitional whole body vibration training produces a greater benefit to exercise capacity in lung transplantat patients (LTx).

Official Title
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Effects of a Whole Body Vibration Training on the Exercise Performance in Patients After Lung Transplantation

Conditions
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Patients Following Lung Transplantation (Single and Double)

Intervention / Treatment
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* Other: Pulmonary rehabilitation + whole body vibration training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: participation in an inpatient rehabilitation program double or single lung transplantation due to chronic obstructive pulmonary disease, Alpha-1-antitrypsine deficiency, interstitial lung disease Exclusion Criteria: severe exacerbation in the last 4 weeks with the necessity of delivering antibiotics/ corticosteroids non-compliance

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Whole body vibration training<br>Whole body vibration training in addition to pulmonary rehabilitation | Other: Pulmonary rehabilitation + whole body vibration training<br>* standard inpatient rehabilitation program including endurance and strength plus squats on a vibration plate for 4x2 minutes, 3 times per week<br>* Other names: Galileo training;|
| No Intervention: No whole body vibration training<br>Pulmonary rehabilitation without whole body vibration training | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in 6-minute walking distance |  | change from baseline to day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Wmax | maximum workload in incremental cycling test | change from baseline to day 21 | 
| change in Fmax | maximum isometric quadriceps force | change from baseline to day 21 | 
| change in fibre cross sectional area | cross sectional area of the M.rectus femoris, measured by ultrasound | change from baseline to day 21 | 
| change in chair rise time | chair rise test: to get from a sitting position to a standing, measuring the time for 5 repetitions | change from baseline to day 21 | 
| change in quality of life | SF-36 questionnaire and CRQ questionnaire | change from baseline to day 21 | 
| change in body cell mass | measured by bio-impedance analysis | change from baseline to day 21 | 
| change in IGF-1 | IGF-1, measured in a blood sample | change from baseline to day 21 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung transplantation, whole body vibration, exercise training, pulmonary rehabilitation