Exercise Training After Transcatheter Aortic Valve Implantation

Transcatheter Aortic Valve Replacement Clinical Trial

— SPORT:TAVI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01935297
• Other study ID #: F/14/12
• Status: Completed
• Phase: N/A
• First received: July 5, 2013
• Last updated: January 22, 2015
• Start date: June 2013
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

patients up to 6 months after transcatheter aortic valve implantation

Exclusion Criteria:

inability to perform exercise on bicycles valve dysfunction

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Transcatheter Aortic Valve Replacement

Intervention

Behavioral:
• Exercise
endurance and resistance exercise 3x/week for 8 weeks

Locations

Country	Name	City	State
Germany	Department of prevention, rehabilitation and sports medicine	Munich	Bavaria

Sponsors (3)

Lead Sponsor	Collaborator
Technische Universität München	Deutsches Herzzentrum Muenchen, Klinikum der Universitaet Muenchen, Grosshadern

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of valve function	Assessed by echocardiography	Baseline to 8 weeks	Yes
Primary	Change of peak oxygen uptake		Baseline to 8 weeks	No
Secondary	Change of quality of life	Assessed by SF-12 and KCCQ questionnaires	Baseline to 8 weeks	No