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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo group | Placebo Comparator | This group will not do any specific training baseline and week 4 investigation will be done only | |
| Exercise Group Galileo PAH | Active Comparator | The intervention/exercise group will do whole body vibration training on 4 days a week for 60 minutes over 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Group Galileo PAH | Device | The intervention/exercise group will do whole body vibration training on 4 days a week for 60 minutes over 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| changes in 6-Minute Walk Distance (6MWD) | baseline and week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Quality of life | baseline and week 4 | |
| Changes in peak Vo2 | baseline and week 4 | |
| Changes in muscle power |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Felix Gerhardt, PhD | Klinik III für Innere Medizin Uniklinik Köln | Principal Investigator |
| Stephan Rosenkranz, PhD | Klinik III für Innere Medizin der Uniklinik Köln | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spezialambulanz für pulmonale Hypertonie Uniklinik Köln | Cologne | North Rhine-Westphalia | 50937 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28100544 | Derived | 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. |
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| ID | Term |
|---|---|
| D065627 | Familial Primary Pulmonary Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| baseline and week 4 |