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| Name | Class |
|---|---|
| Deutsches Herzzentrum Muenchen | OTHER |
| Klinikum der Universitaet Muenchen, Grosshadern | OTHER |
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This pilot study will evaluate the effect of a rehabilitative exercise training on exercise capacity in patients after percutaneous aortic valve replacement. It will additionally evaluate the safety of such an approach and the effect on life quality. We hypothesize that regular structured exercise improves exercise capacity in these patients beyond the sole effect of the valve procedure.
The study will include 30 patients and randomize them in a 1:1-fashion to either a training or a usual care group. The training group will undergo 8 weeks of combined endurance and resistance training according to a standard protocol, but with individual adjustment if required. The usual care group will receive general advice but no structured exercise program. Exercise capacity is assessed by cardiopulmonary exercise testing and by the 6 minute walk test prior to and after the intervention period. In addition, life quality will be assessed by validated questionnaires, while safety will be assessed by recording adverse events and by echocardiography.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise | Active Comparator | 8 weeks of supervised, structured, combined endurance and resistance training |
|
| Control | No Intervention | Patients receive usual care, regular exercise is not recommended but also not prohibited |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | endurance and resistance exercise 3x/week for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of peak oxygen uptake | Baseline to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of quality of life | Assessed by SF-12 and KCCQ questionnaires | Baseline to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of valve function | Assessed by echocardiography | Baseline to 8 weeks |
Inclusion Criteria:
patients up to 6 months after transcatheter aortic valve implantation
Exclusion Criteria:
inability to perform exercise on bicycles valve dysfunction
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| Name | Affiliation | Role |
|---|---|---|
| Axel Pressler, MD | Prevention, Rehabilitation & Sports Medicine, Technische Universität München, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of prevention, rehabilitation and sports medicine | Munich | Bavaria | 80992 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29553289 | Derived | Pressler A, Forschner L, Hummel J, Haller B, Christle JW, Halle M. Long-term effect of exercise training in patients after transcatheter aortic valve implantation: Follow-up of the SPORT:TAVI randomised pilot study. Eur J Prev Cardiol. 2018 May;25(8):794-801. doi: 10.1177/2047487318765233. Epub 2018 Mar 19. | |
| 27914499 | Derived |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Pressler A, Christle JW, Lechner B, Grabs V, Haller B, Hettich I, Jochheim D, Mehilli J, Lange R, Bleiziffer S, Halle M. Exercise training improves exercise capacity and quality of life after transcatheter aortic valve implantation: A randomized pilot trial. Am Heart J. 2016 Dec;182:44-53. doi: 10.1016/j.ahj.2016.08.007. Epub 2016 Aug 26. |