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.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Changes in 6 Minute Walking distance
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
3-month home based training on whole body vibration platform
This Group will receive a training device to perform their given exercises on
Intervention: Body Vibration platform GALILEO (Device)
3-month home based training on floor
This Group will perform their given exercises at home on the floor
Intervention: exercises at home on the floor (Other)
Outcomes
Primary Outcomes
Changes in 6 Minute Walking distance
Time Frame: 4 weeks interm analysis
Secondary Outcomes
- Changes in Quality of Life(4 weeks)
- Changes in Peak Oxygen uptake in cardiopulmonary exercise testing (CPET)(4 weeks)
Investigators
Felix Gerhardt
Dr. med.
Klinikum der Universität Köln