Ignite Creation Date:
2024-05-06 @ 9:30 AM
Last Modification Date:
2024-10-26 @ 12:15 PM
Study NCT ID:
NCT02997683
Status:
UNKNOWN
Last Update Posted:
2019-04-26
First Post:
2016-12-16
Brief Title:
3-Month Home-based Training With Whole Body Vibration Device in Patients With PAH GALILEO-PAH-HOME
Sponsor:
Klinikum der Universität Köln
Organization:
Klinikum der Universität Köln
Study Overview
Official Title:
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 in an Extended 3-month Home Based Training Background and Rationale for the Proposal Capacity and the Ability to Exercise in Patients With PAH is Limited Primary Scientific Question AddressedChanges in Muscle Power Changes in 6-Minute Walk Distance 6MWD and Changes in QoL Are to be Evaluated
Status:
UNKNOWN
Status Verified Date:
2019-04
Last Known Status:
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:
GALILEOHOME
Brief Summary:
In order to evaluate Long term effects of whole Body Vibration wbv in patients with PAH and CTEPH patients will get a training device to use at home for 3 months Patients in the Intervention group will be introduced in the training program on the wbv-device in the study center 3-4 times and baseline Parameters will be collected before start of the home based training Patients randomized into the placebo arm be introduced into the training program according to the interventional arm but not perfoming the exercises on the wbv-device but on the floor
Detailed Description:
Screening day -21 until day -7 Subjects will be evaluated according to In- and Exclusion critera
Randomization day -7 Subjects will be randomized to either Intervention Group training on wbv platform or non-Intervention Group training without wbv
Introduction Week -1-7d-d1 All subjects will receive introduction in their training
Month 1
Day 1 From this day subjects are supposed to start their training accoridng to protocol
Day 2 Telephone Visit
Day 5 Telephone Visit
Day 7 Telephone Visit
Day 10 Telephone Visit
Day 13 Telephone Visit
Day 20 Telephone Visit
Day 27 Telephone Visit
Week 4 Day 28 Study center Visit 6MWD QoL-Questionnaire AEs re-training
Month 2
Week 5 Day 34
Week 6 Day 41
Week 7 Day 48
Week 8 Day 55
Month 3
Week 9 Day 62
Week 10 Day 69
Week 11 Day 76
Week 12 Day 83 Final Visit
Randomization day -7 Subjects will be randomized to either Intervention Group training on wbv platform or non-Intervention Group training without wbv
Introduction Week -1-7d-d1 All subjects will receive introduction in their training
Month 1
Day 1 From this day subjects are supposed to start their training accoridng to protocol
Day 2 Telephone Visit
Day 5 Telephone Visit
Day 7 Telephone Visit
Day 10 Telephone Visit
Day 13 Telephone Visit
Day 20 Telephone Visit
Day 27 Telephone Visit
Week 4 Day 28 Study center Visit 6MWD QoL-Questionnaire AEs re-training
Month 2
Week 5 Day 34
Week 6 Day 41
Week 7 Day 48
Week 8 Day 55
Month 3
Week 9 Day 62
Week 10 Day 69
Week 11 Day 76
Week 12 Day 83 Final Visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None