Ignite Creation Date:
2024-05-06 @ 1:15 AM
Last Modification Date:
2024-10-26 @ 11:01 AM
Study NCT ID:
NCT01763112
Status:
UNKNOWN
Last Update Posted:
2015-03-31
First Post:
2013-01-04
Brief Title:
Training With Whole Body Vibration Device in Patients With PAH
Sponsor:
Klinikum der Universität Köln
Organization:
Klinikum der Universität Köln
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2015-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GALILEO-PAH
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 proposalCapacity 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 addressedChanges 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None