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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02997683

Acronym

GALILEOHOME

Enrollment

Registered

2016-12-20

Start date

2018-01-01

Completion date

2019-12-31

Last updated

2019-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

Interventions

DEVICEBody Vibration platform GALILEO

3 month home based training on whole Body Vibration platform GALILEO

OTHERexercises at home on the floor

exercises at home on the floor

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Changes in 6 Minute Walking distance	3 months

Secondary

Measure	Time frame
Changes in Peak Oxygen uptake in cardiopulmonary exercise testing (CPET)	3 months
Changes in Quality of Life	3 months

Countries

Germany

Contacts

Primary ContactFelix Gerhardt, MD

felix.gerhardt@uk-koeln.de+4947889413

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026