Training With Whole Body Vibration Device in Patients With PAH

Study Overview
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Brief Summary
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Title of study / project: Influence of training with whole body vibration device on Quality of Life (QoL), exercise capacity, as well as on the effects of muscle power and muscle function in patients with pulmonal arterial hypertension (PAH). Background and rationale for the proposal:Capacity and the ability to exercise, in patients with PAH is limited. There is a few investigations evaluating the effects of the training with whole body vibration (wbv) in adults. It was shown that wbv-training could improve muscle power, QoL, body balance and had positive effects on the neuromuscular system. Primary scientific question addressed:Changes in muscle power, changes in 6-Minute Walk Distance (6MWD) and changes in QoL are to be evaluated.

Detailed Description
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Study Design: Open Monocentric prospective randomized observational trial Study arms: Treatment group (4-weeks wbv training) planned 20 patients Control group: planned 20 patients Endpoint (-s): Changes in muscle power, changes in 6-Minute Walk Distance (6MWD), changes in QoL changes in peak VO2 (bike exercise test) Major study procedures: Blood samples, vital parameters, questionnaires, echocardiography, lung function test, blood gas analysis, bike exercise test, 6-Minute Walk test, ECG, Chair rising test, power plate measurement, walk across test

Official Title
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Influence of Training With Whole Body Vibration Device (Galileo) on Quality of Life (QoL), Exercise Capacity, as Well as on the Effects of Muscle Power and Muscle Function in Patients With Pulmonal Arterial Hypertension (PAH). (GALILEO PAH)

Conditions
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Pulmonary Artery Hypertension

Intervention / Treatment
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* Device: Exercise Group Galileo PAH


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women age 18-90 years Signed informed consent Symptomatic PAH (idiopathic, hereditary or associated with systemic scleroderma) Invasively confirmed PAH 6MWT ≥ 50 m Stable specific therapy for at least 2 months Ability to perform bike test Ability to perform wbv training NYHA/WHO-FC II-III Exclusion Criteria: any other PAH/PH than idiopathic, hereditary or associated with systemic scleroderma Rehabilitation or other training concept performed within 2 months before inclusion pregnancy acute thrombosis newly implanted Hip or Knee recent bone fracture Disability to confirm consent NYHA/WHO-FC IV

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Placebo Comparator: Placebo group<br>This group will not do any specific training baseline and week 4 investigation will be done only | |
| Active Comparator: Exercise Group Galileo PAH<br>The intervention/exercise group will do whole body vibration training on 4 days a week for 60 minutes over 4 weeks | Device: Exercise Group Galileo PAH<br>* The intervention/exercise group will do whole body vibration training on 4 days a week for 60 minutes over 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in 6-Minute Walk Distance (6MWD) |  | baseline and week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Quality of life |  | baseline and week 4 | 
| Changes in peak Vo2 |  | baseline and week 4 | 
| Changes in muscle power |  | baseline and week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influence of training with whole body vibration device