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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3-month home based training on whole body vibration platform | Experimental | This Group will receive a training device to perform their given exercises on |
|
| 3-month home based training on floor | Placebo Comparator | This Group will perform their given exercises at home on the floor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Body Vibration platform GALILEO | Device | 3 month home based training on whole Body Vibration platform GALILEO |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in 6 Minute Walking distance | 3 months | |
| Changes in 6 Minute Walking distance | 4 weeks interm analysis |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
any other PAH/PH than idiopathic, hereditary, associated with systemic scleroderma or CTEPH
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Felix Gerhardt, MD | Contact | +4947889413 | felix.gerhardt@uk-koeln.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spezialambulanz für pulmonale Hypertonie Uniklinik Köln | Recruiting | Cologne | North Rhine-Westphalia | 50937 | Germany |
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| exercises at home on the floor | Other | exercises at home on the floor |
|
| Changes in Quality of Life |
| 3 months |
| Changes in Quality of Life | 4 weeks |