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Completed

NCT Number: NCT01935297

Exercise Training After Transcatheter Aortic Valve Implantation

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.

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Key information

Conditions

Transcatheter Aortic Valve Replacement

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of prevention, rehabilitation and sports medicine

Munich, Bavaria, 80992, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patients up to 6 months after transcatheter aortic valve implantation

Exclusion criteria

inability to perform exercise on bicycles valve dysfunction

Treatment and study plan

Exercise

Behavioral

endurance and resistance exercise 3x/week for 8 weeks

Primary outcomes

  1. Change of peak oxygen uptake

    Time frame: Baseline to 8 weeks

Secondary outcomes

  1. Change of quality of life

    Time frame: Baseline to 8 weeks

    Assessed by SF-12 and KCCQ questionnaires

Other outcomes

  1. Change of valve function

    Time frame: Baseline to 8 weeks

    Assessed by echocardiography

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Collaborators

  • Deutsches Herzzentrum Muenchen
  • Klinikum der Universitaet Muenchen, Grosshadern

Registry information

Official study title

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

Acronym: SPORT:TAVI

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 5, 2013
Registry last updated
Jan 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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