Exercise Training After Transcatheter Aortic Valve Implantation (SPORT:TAVI)

January 22, 2015 updated by: Technical University of Munich

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 80992
        • Department of Prevention, Rehabilitation and Sports Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

patients up to 6 months after transcatheter aortic valve implantation

Exclusion Criteria:

inability to perform exercise on bicycles valve dysfunction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Exercise
8 weeks of supervised, structured, combined endurance and resistance training
Behavioral: Exercise
endurance and resistance exercise 3x/week for 8 weeks
No Intervention: Control
Patients receive usual care, regular exercise is not recommended but also not prohibited

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of peak oxygen uptake
Time Frame: Baseline to 8 weeks
Baseline to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of quality of life
Time Frame: Baseline to 8 weeks
Assessed by SF-12 and KCCQ questionnaires
Baseline to 8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of valve function
Time Frame: Baseline to 8 weeks
Assessed by echocardiography
Baseline to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Collaborators

Deutsches Herzzentrum Muenchen
Klinikum der Universitaet Muenchen, Grosshadern

Investigators

  • Principal Investigator: Axel Pressler, MD, Prevention, Rehabilitation & Sports Medicine, Technische Universität München, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

July 5, 2013

First Submitted That Met QC Criteria

August 30, 2013

First Posted (Estimate)

September 5, 2013

Study Record Updates

Last Update Posted (Estimate)

January 26, 2015

Last Update Submitted That Met QC Criteria

January 22, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • F/14/12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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