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Exercise Training After Transcatheter Aortic Valve Implantation

Safety, Applicability and Outcome of Regular Exercise Training After Transcatheter Aortic Valve Implantation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01935297
Acronym
SPORT:TAVI
Enrollment
30
Registered
2013-09-05
Start date
2013-06-30
Completion date
2015-01-31
Last updated
2015-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transcatheter Aortic Valve Replacement

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

BEHAVIORALExercise

endurance and resistance exercise 3x/week for 8 weeks

Sponsors

Deutsches Herzzentrum Muenchen
CollaboratorOTHER
Klinikum der Universitaet Muenchen, Grosshadern
CollaboratorOTHER
Technical University of Munich
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

MeasureTime frame
Change of peak oxygen uptakeBaseline to 8 weeks

Secondary

MeasureTime frameDescription
Change of quality of lifeBaseline to 8 weeksAssessed by SF-12 and KCCQ questionnaires

Other

MeasureTime frameDescription
Change of valve functionBaseline to 8 weeksAssessed by echocardiography

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026