Clinical trial NCT02997683: 3-Month Home-based Training With Whole Body Vibration Device in Patients With PAH (GALILEO-PAH-HOME)
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Changes in Six Minute Walking Distance, Peak Oxygen Uptake, Quality of Life
Lead sponsor: Klinikum der Universität Köln
Sponsor class: OTHER
First posted: 2016-12-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Changes in 6 Minute Walking distance
timeFrame: 3 months
measure: Changes in 6 Minute Walking distance
timeFrame: 4 weeks interm analysis
Secondary outcomes:
measure: Changes in Peak Oxygen uptake in cardiopulmonary exercise testing (CPET)
timeFrame: 3 months
measure: Changes in Peak Oxygen uptake in cardiopulmonary exercise testing (CPET)
timeFrame: 4 weeks
measure: Changes in Quality of Life
timeFrame: 3 months
measure: Changes in Quality of Life
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Köln
country: Germany
facility: Spezialambulanz für pulmonale Hypertonie Uniklinik Köln
state: NRW
Study officials:
References: