Clinical trial NCT01935297: Exercise Training After Transcatheter Aortic Valve Implantation
Official title: Safety, Applicability and Outcome of Regular Exercise Training After Transcatheter Aortic Valve Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transcatheter Aortic Valve Replacement
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Deutsches Herzzentrum Muenchen
name: Klinikum der Universitaet Muenchen, Grosshadern
First posted: 2013-09-05
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

patients up to 6 months after transcatheter aortic valve implantation

Exclusion Criteria:

inability to perform exercise on bicycles valve dysfunction

Primary outcomes:
measure: Change of peak oxygen uptake
timeFrame: Baseline to 8 weeks
Secondary outcomes:
measure: Change of quality of life
timeFrame: Baseline to 8 weeks
Other outcomes:
measure: Change of valve function
timeFrame: Baseline to 8 weeks
Locations:
city: Munich
country: Germany
facility: Department of prevention, rehabilitation and sports medicine
state: Bavaria
Study officials:
affiliation: Prevention, Rehabilitation & Sports Medicine, Technische Universität München, Germany
name: Axel Pressler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pressler A, Forschner L, Hummel J, Haller B, Christle JW, Halle M. Long-term effect of exercise training in patients after transcatheter aortic valve implantation: Follow-up of the SPORT:TAVI randomised pilot study. Eur J Prev Cardiol. 2018 May;25(8):794-801. doi: 10.1177/2047487318765233. Epub 2018 Mar 19.
citation: Pressler A, Christle JW, Lechner B, Grabs V, Haller B, Hettich I, Jochheim D, Mehilli J, Lange R, Bleiziffer S, Halle M. Exercise training improves exercise capacity and quality of life after transcatheter aortic valve implantation: A randomized pilot trial. Am Heart J. 2016 Dec;182:44-53. doi: 10.1016/j.ahj.2016.08.007. Epub 2016 Aug 26.