Training With Whole Body Vibration Device in Patients With PAH

Pulmonary Artery Hypertension Clinical Trial

— 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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01763112
• Other study ID #: 001
• Status: Active, not recruiting
• Phase: N/A
• First received: January 4, 2013
• Last updated: March 30, 2015
• Start date: January 2013
• Est. completion date: June 2015

Study information

• Verified date: March 2015
• Source: Klinikum der Universität Köln
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Artery Hypertension

Intervention

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

Locations

Country	Name	City	State
Germany	Spezialambulanz für pulmonale Hypertonie Uniklinik Köln	Köln	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Klinikum der Universität Köln

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in 6-Minute Walk Distance (6MWD)		baseline and week 4	No
Secondary	Changes in Quality of life		baseline and week 4	No
Secondary	Changes in peak Vo2		baseline and week 4	No
Secondary	Changes in muscle power		baseline and week 4	No