Exercise Training After Transcatheter Aortic Valve Implantation

Not Applicable

Completed

• Conditions: Transcatheter Aortic Valve Replacement
• Interventions: Behavioral: Exercise

• Registration Number: NCT01935297
• Lead Sponsor: Technical University of Munich

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.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-07-05
• Study First Submitted QC: 2013-08-30
• Study First Posted: 2013-09-05
• Status Verified: 2015-01
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Last Update Submitted: 2015-01-22
• Last Update Posted: 2015-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

patients up to 6 months after transcatheter aortic valve implantation

Exclusion Criteria

inability to perform exercise on bicycles valve dysfunction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	Exercise	8 weeks of supervised, structured, combined endurance and resistance training

Primary Outcome Measures

Name	Time	Method
Change of peak oxygen uptake	Baseline to 8 weeks

Secondary Outcome Measures

Name	Time	Method
Change of quality of life	Baseline to 8 weeks	Assessed by SF-12 and KCCQ questionnaires

Trial Locations

Locations (1)

Department of prevention, rehabilitation and sports medicine; 🇩🇪 Munich, Bavaria, Germany