Training With Whole Body Vibration Device in Patients With PAH (GALILEO-PAH)

Klinikum der Universität Köln

Status: Unknown

Conditions: Pulmonary Artery Hypertension

Treatments: Device: Exercise Group Galileo PAH

Study type: Interventional

Funder types: Other

Identifiers

NCT01763112

001

Details and patient eligibility

About

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.

Full 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

Enrollment: 20 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups, including a placebo group

Placebo group

Placebo Comparator group

Description:

This group will not do any specific training baseline and week 4 investigation will be done only

Exercise Group Galileo PAH

Active Comparator group

Description:

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

Treatment:

Device: Exercise Group Galileo PAH