Training With Whole Body Vibration Device in Patients With PAH

Influence of Training With Whole Body Vibration Device (Galileo) 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). (GALILEO PAH)

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01763112

Acronym

GALILEO-PAH

Enrollment

Registered

2013-01-08

Start date

2013-01-31

Completion date

2015-06-30

Last updated

2015-03-31

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

Conditions

Pulmonary Artery Hypertension

Keywords

Influence of training with whole body vibration device

Brief summary

Title of study / project: 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). Background and rationale for the proposal:Capacity and the ability to exercise, in patients with PAH is limited. There is a few investigations evaluating the effects of the training with whole body vibration (wbv) in adults. It was shown that wbv-training could improve muscle power, QoL, body balance and had positive effects on the neuromuscular system. Primary scientific question addressed:Changes in muscle power, changes in 6-Minute Walk Distance (6MWD) and changes in QoL are to be evaluated.

Detailed description

Study Design: Open Monocentric prospective randomized observational trial Study arms: Treatment group (4-weeks wbv training) planned 20 patients Control group: planned 20 patients Endpoint (-s): Changes in muscle power, changes in 6-Minute Walk Distance (6MWD), changes in QoL changes in peak VO2 (bike exercise test) Major study procedures: Blood samples, vital parameters, questionnaires, echocardiography, lung function test, blood gas analysis, bike exercise test, 6-Minute Walk test, ECG, Chair rising test, power plate measurement, walk across test

Interventions

DEVICEExercise Group Galileo PAH

The intervention/exercise group will do whole body vibration training on 4 days a week for 60 minutes over 4 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

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) * Invasively confirmed PAH * 6MWT ≥ 50 m * Stable specific therapy for at least 2 months * Ability to perform bike test * Ability to perform wbv training * NYHA/WHO-FC II-III

Exclusion criteria

* any other PAH/PH than idiopathic, hereditary or associated with systemic scleroderma * Rehabilitation or other training concept performed within 2 months before inclusion * pregnancy * acute thrombosis * newly implanted Hip or Knee * recent bone fracture * Disability to confirm consent * NYHA/WHO-FC IV

Design outcomes

Primary

Measure	Time frame
changes in 6-Minute Walk Distance (6MWD)	baseline and week 4

Secondary

Measure	Time frame
Changes in Quality of life	baseline and week 4
Changes in peak Vo2	baseline and week 4
Changes in muscle power	baseline and week 4

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026