GALILEO-PAH: Training With Whole Body Vibration Device in Patients With PAH

Sponsor

Klinikum der Universität Köln (Other)

Overall Status

Unknown status

CT.gov ID

NCT01763112

Collaborator

(none)

Enrollment

Location

Arms

28.9

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Artery Hypertension	Device: Exercise Group Galileo PAH	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Study Start Date :

Jan 1, 2013

Anticipated Primary Completion Date :

Jun 1, 2015

Anticipated Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo group This group will not do any specific training baseline and week 4 investigation will be done only
Active Comparator: 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	Device: 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

Arm

Intervention/Treatment

Placebo Comparator: Placebo group

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

Active Comparator: 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

Device: 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

Outcome Measures

Primary Outcome Measures

changes in 6-Minute Walk Distance (6MWD) [baseline and week 4]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Spezialambulanz für pulmonale Hypertonie Uniklinik Köln	Köln	NRW	Germany	50937

Sponsors and Collaborators

Klinikum der Universität Köln

Investigators

Principal Investigator: Felix Gerhardt, PhD, Klinik III für Innere Medizin Uniklinik Köln
Principal Investigator: Stephan Rosenkranz, PhD, Klinik III für Innere Medizin der Uniklinik Köln

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Felix Gerhardt, PhD, Klinikum der Universität Köln

ClinicalTrials.gov Identifier:

NCT01763112

Other Study ID Numbers:

First Posted:

Jan 8, 2013

Last Update Posted:

Mar 31, 2015

Last Verified:

Mar 1, 2015

Keywords provided by Felix Gerhardt, PhD, Klinikum der Universität Köln

Influence of training with whole body vibration device

Additional relevant MeSH terms:

Pulmonary Arterial Hypertension

Hypertension

Study Results

No Results Posted as of Mar 31, 2015