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.
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.
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
Inclusion Criteria:
Exclusion Criteria:
any other PAH/PH than idiopathic, hereditary, associated with systemic scleroderma or CTEPH
felix.gerhardt@uk-koeln.de+4947889413