Exercise Training After Transcatheter Aortic Valve Implantation — SPORT:TAVI  

Transcatheter Aortic Valve Replacement Clinical Trial

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

Status Completed

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.

Clinical Trial 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. ;

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

• NCT number: NCT01935297
• Study type: Interventional
• Source: Technische Universität München
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Completion date: January 2015