3-Month Home-based Training With Whole Body Vibration Device in Patients With PAH (GALILEO-PAH-HOME)

Study Overview
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Brief Summary
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In order to evaluate Long term effects of whole Body Vibration (wbv) in patients with PAH and CTEPH patients will get a training device to use at home for 3 months. Patients in the Intervention group will be introduced in the training program on the wbv-device in the study center 3-4 times and baseline Parameters will be collected before start of the home based training. Patients randomized into the placebo arm be introduced into the training program according to the interventional arm but not perfoming the exercises on the wbv-device but on the floor.

Detailed Description
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Screening (day -21 until day -7): Subjects will be evaluated according to In- and Exclusion critera Randomization (day -7): Subjects will be randomized to either Intervention Group (training on wbv platform) or non-Intervention Group (training without wbv). Introduction Week -1(-7d-d1): All subjects will receive introduction in their training Month 1: Day 1: From this day subjects are supposed to start their training accoridng to protocol Day 2: Telephone Visit Day 5: Telephone Visit Day 7: Telephone Visit Day 10: Telephone Visit Day 13: Telephone Visit Day 20: Telephone Visit Day 27: Telephone Visit Week 4, Day 28: Study center Visit: 6MWD, QoL-Questionnaire, AEs, re-training Month 2: Week 5, Day 34: Week 6, Day 41: Week 7, Day 48: Week 8, Day 55: Month 3: Week 9, Day 62: Week 10, Day 69: Week 11, Day 76: Week 12, Day 83: Final Visit

Official Title
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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) in an Extended 3-month Home Based Training. Background and Rationale for the Proposal: Capacity and the Ability to Exercise, in Patients With PAH is Limited. Primary Scientific Question Addressed:Changes in Muscle Power, Changes in 6-Minute Walk Distance (6MWD) and Changes in QoL Are to be Evaluated.

Conditions
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Changes in Six Minute Walking Distance, Peak Oxygen Uptake, Quality of Life

Intervention / Treatment
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* Device: Body Vibration platform GALILEO
* Other: exercises at home on the floor


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) Persistend or inoperable CTEPH Invasively confirmed PAH 6MWT ≥ 50 - 450 m Stable specific therapy for at least 6 weeks Ability to perform bike test Ability to perform wbv training NYHA/WHO-FC II-III Exclusion Criteria: any other PAH/PH than idiopathic, hereditary, associated with systemic scleroderma or CTEPH Rehabilitation or other training concept performed within 6 weeks before inclusion pregnancy acute thrombosis newly implanted Hip or Knee recent bone fracture Disability to confirm consent NYHA/WHO-FC IV 6MWD below 50 or above 450 m

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3-month home based training on whole body vibration platform<br>This Group will receive a training device to perform their given exercises on | Device: Body Vibration platform GALILEO<br>* 3 month home based training on whole Body Vibration platform GALILEO<br>|
| Placebo Comparator: 3-month home based training on floor<br>This Group will perform their given exercises at home on the floor | Other: exercises at home on the floor<br>* exercises at home on the floor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in 6 Minute Walking distance |  | 3 months | 
| Changes in 6 Minute Walking distance |  | 4 weeks interm analysis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Peak Oxygen uptake in cardiopulmonary exercise testing (CPET) |  | 3 months | 
| Changes in Peak Oxygen uptake in cardiopulmonary exercise testing (CPET) |  | 4 weeks | 
| Changes in Quality of Life |  | 3 months | 
| Changes in Quality of Life |  | 4 weeks |