Exercise Training After Transcatheter Aortic Valve Implantation
SPORT:TAVI
Safety, Applicability and Outcome of Regular Exercise Training After Transcatheter Aortic Valve Implantation
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 5, 2013
CompletedFirst Posted
Study publicly available on registry
September 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedJanuary 26, 2015
January 1, 2015
1.6 years
July 5, 2013
January 22, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change of peak oxygen uptake
Baseline to 8 weeks
Secondary Outcomes (1)
Change of quality of life
Baseline to 8 weeks
Other Outcomes (1)
Change of valve function
Baseline to 8 weeks
Study Arms (2)
Exercise
ACTIVE COMPARATOR8 weeks of supervised, structured, combined endurance and resistance training
Control
NO INTERVENTIONPatients receive usual care, regular exercise is not recommended but also not prohibited
Interventions
Eligibility Criteria
You may qualify if:
- patients up to 6 months after transcatheter aortic valve implantation
You may not qualify if:
- inability to perform exercise on bicycles valve dysfunction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Technical University of Munichlead
- Deutsches Herzzentrum Muenchencollaborator
- Klinikum der Universitaet Muenchen, Grosshaderncollaborator
Study Sites (1)
Department of prevention, rehabilitation and sports medicine
Munich, Bavaria, 80992, Germany
Related Publications (2)
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.
PMID: 29553289DERIVEDPressler 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.
PMID: 27914499DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Axel Pressler, MD
Prevention, Rehabilitation & Sports Medicine, Technische Universität München, Germany
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2013
First Posted
September 5, 2013
Study Start
June 1, 2013
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
January 26, 2015
Record last verified: 2015-01