NCT02997683

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

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Klinikum der Universität Köln · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

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

Interventions

Type	Name	Description
DEVICE	Body Vibration platform GALILEO	3 month home based training on whole Body Vibration platform GALILEO
OTHER	exercises at home on the floor	exercises at home on the floor

Timeline

• Start date: 2018-01-01
• Primary completion: 2019-11-01
• Completion: 2019-12-01
• First posted: 2016-12-20
• Last updated: 2019-04-26

Locations

1 site across 1 country: Germany