Overview

This trial is active, not recruiting.

Condition pulmonary artery hypertension
Treatment exercise group galileo pah
Sponsor Klinikum der Universität Köln
Start date January 2013
End date June 2015
Trial size 20 participants
Trial identifier NCT01763112, 001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Placebo Comparator)
This group will not do any specific training baseline and week 4 investigation will be done only
(Active Comparator)
The intervention/exercise group will do whole body vibration training on 4 days a week for 60 minutes over 4 weeks
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 Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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

Additional Information

Official title 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)
Principal investigator Felix Gerhardt, PhD
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
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Klinikum der Universität Köln.