NCT01935297

Exercise Training After Transcatheter Aortic Valve Implantation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Technical University of Munich · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Transcatheter Aortic Valve Replacement

Interventions

Type	Name	Description
BEHAVIORAL	Exercise	endurance and resistance exercise 3x/week for 8 weeks

Timeline

• Start date: 2013-06-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2013-09-05
• Last updated: 2015-01-26

Locations

1 site across 1 country: Germany