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Exercise Training After Transcatheter Aortic Valve Implantation (SPORT:TAVI)

T

Technical University of Munich

Status

Completed

Conditions

Transcatheter Aortic Valve Replacement

Treatments

Behavioral: Exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT01935297
F/14/12

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

patients up to 6 months after transcatheter aortic valve implantation

Exclusion criteria

inability to perform exercise on bicycles valve dysfunction

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Exercise
Active Comparator group
Description:
8 weeks of supervised, structured, combined endurance and resistance training
Treatment:
Behavioral: Exercise
Control
No Intervention group
Description:
Patients receive usual care, regular exercise is not recommended but also not prohibited

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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