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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Klinikum der Universität Köln
Sponsor:
Information provided by (Responsible Party):
Felix Gerhardt, Klinikum der Universität Köln
ClinicalTrials.gov Identifier:
NCT01763112
First received: January 4, 2013
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

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 Intervention
Pulmonary Artery Hypertension
Device: Exercise Group Galileo PAH

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Klinikum der Universität Köln:

Primary Outcome Measures:
  • changes in 6-Minute Walk Distance (6MWD) [ Time Frame: baseline and week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in Quality of life [ Time Frame: baseline and week 4 ] [ Designated as safety issue: No ]
  • Changes in peak Vo2 [ Time Frame: baseline and week 4 ] [ Designated as safety issue: No ]
  • Changes in muscle power [ Time Frame: baseline and week 4 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01763112

Contacts
Contact: Felix Gerhardt, PhD +49221478 ext 89413 felix.gerhardt@uk-koeln.de
Contact: Stephan Rosenkranz, PhD +49221478 ext 32401 stephan.rosenkranz@uk-koeln.de

Locations
Germany
Spezialambulanz für pulmonale Hypertonie Uniklinik Köln Recruiting
Köln, NRW, Germany, 50937
Contact: Felix Gerhardt, PhD    +49221478 ext 89413    felix.gerhardt@uk-koeln.de   
Principal Investigator: Felix Gerhardt, PhD         
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
  More Information

No publications provided

Responsible Party: Felix Gerhardt, PhD, Klinikum der Universität Köln
ClinicalTrials.gov Identifier: NCT01763112     History of Changes
Other Study ID Numbers: 001
Study First Received: January 4, 2013
Last Updated: January 7, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Klinikum der Universität Köln:
Influence of training with whole body vibration device

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 29, 2014