Safety, Applicability and Outcome of Regular Exercise Training After Transcatheter Aortic Valve Implantation
| Registry | NCT01935297, acronym SPORT:TAVI |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 30 (Actual) |
| Sponsor | Technical University of Munich (Other); collaborators: Deutsches Herzzentrum Muenchen, Klinikum der Universitaet Muenchen, Grosshadern |
| Conditions | Transcatheter Aortic Valve Replacement |
| Interventions | Exercise (Behavioral) |
| Dates | start 2013-06-01, primary completion 2015-01-01, completion 2015-01-01, first posted 2013-09-05, last updated 2015-01-26 |
| Locations | 1 site in Germany |
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All trials for Transcatheter Aortic Valve Replacement All trials of Exercise
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Exercise | Active comparator | Behavioral: Exercise | 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 |
Sex: All
Inclusion Criteria: patients up to 6 months after transcatheter aortic valve implantation Exclusion Criteria: inability to perform exercise on bicycles valve dysfunction
| Facility | City | Country | Status |
|---|---|---|---|
| Department of prevention, rehabilitation and sports medicine | Munich, Bavaria | Germany |