Training With Whole Body Vibration Device in Patients With PAH

Not Applicable

• Conditions: Pulmonary Artery Hypertension
• Interventions: Device: Exercise Group Galileo PAH

• Registration Number: NCT01763112
• Lead Sponsor: Klinikum der Universität Köln

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

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-04
• Study First Submitted QC: 2013-01-07
• Study First Posted: 2013-01-08
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-30
• Last Update Posted: 2015-03-31
• Primary Completion: 2015-06
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise Group Galileo PAH	Exercise Group Galileo PAH	The intervention/exercise group will do whole body vibration training on 4 days a week for 60 minutes over 4 weeks

Primary Outcome Measures

Name	Time	Method
changes in 6-Minute Walk Distance (6MWD)	baseline and week 4

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Spezialambulanz für pulmonale Hypertonie Uniklinik Köln; 🇩🇪 Köln, NRW, Germany