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

Primary Purpose

Pulmonary Artery Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Exercise Group Galileo PAH
Sponsored by
Klinikum der Universität Köln
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Artery Hypertension focused on measuring Influence of training with whole body vibration device

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Spezialambulanz für pulmonale Hypertonie Uniklinik Köln

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo group

Exercise Group Galileo PAH

Arm Description

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

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

Outcomes

Primary Outcome Measures

changes in 6-Minute Walk Distance (6MWD)

Secondary Outcome Measures

Changes in Quality of life
Changes in peak Vo2
Changes in muscle power

Full Information

First Posted
January 4, 2013
Last Updated
March 30, 2015
Sponsor
Klinikum der Universität Köln
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1. Study Identification

Unique Protocol Identification Number
NCT01763112
Brief Title
Training With Whole Body Vibration Device in Patients With PAH
Acronym
GALILEO-PAH
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 Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Klinikum der Universität Köln

4. Oversight

Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Artery Hypertension
Keywords
Influence of training with whole body vibration device

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
This group will not do any specific training baseline and week 4 investigation will be done only
Arm Title
Exercise Group Galileo PAH
Arm Type
Active Comparator
Arm Description
The intervention/exercise group will do whole body vibration training on 4 days a week for 60 minutes over 4 weeks
Intervention Type
Device
Intervention Name(s)
Exercise Group Galileo PAH
Intervention Description
The intervention/exercise group will do whole body vibration training on 4 days a week for 60 minutes over 4 weeks
Primary Outcome Measure Information:
Title
changes in 6-Minute Walk Distance (6MWD)
Time Frame
baseline and week 4
Secondary Outcome Measure Information:
Title
Changes in Quality of life
Time Frame
baseline and week 4
Title
Changes in peak Vo2
Time Frame
baseline and week 4
Title
Changes in muscle power
Time Frame
baseline and week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felix Gerhardt, PhD
Organizational Affiliation
Klinik III für Innere Medizin Uniklinik Köln
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephan Rosenkranz, PhD
Organizational Affiliation
Klinik III für Innere Medizin der Uniklinik Köln
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spezialambulanz für pulmonale Hypertonie Uniklinik Köln
City
Köln
State/Province
NRW
ZIP/Postal Code
50937
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
28100544
Citation
Gerhardt F, Dumitrescu D, Gartner C, Beccard R, Viethen T, Kramer T, Baldus S, Hellmich M, Schonau E, Rosenkranz S. Oscillatory whole-body vibration improves exercise capacity and physical performance in pulmonary arterial hypertension: a randomised clinical study. Heart. 2017 Apr;103(8):592-598. doi: 10.1136/heartjnl-2016-309852. Epub 2017 Jan 18.
Results Reference
derived

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Training With Whole Body Vibration Device in Patients With PAH

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