Transcatheter Aortic Valve Replacement
Conditions
Brief summary
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.
Detailed description
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.
Interventions
endurance and resistance exercise 3x/week for 8 weeks
Sponsors
Study design
Eligibility
Inclusion criteria
patients up to 6 months after transcatheter aortic valve implantation
Exclusion criteria
inability to perform exercise on bicycles valve dysfunction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of peak oxygen uptake | Baseline to 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of quality of life | Baseline to 8 weeks | Assessed by SF-12 and KCCQ questionnaires |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change of valve function | Baseline to 8 weeks | Assessed by echocardiography |
Countries
Germany