Exercise Training After Transcatheter Aortic Valve Implantation

Study Overview
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Brief Summary
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In this prospective, controlled trial, patient after TAVI will be randomized to either exercise training or usual care group.

Detailed Description
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Patients after transcatheter aortic valve replacement (TAVI) are particularly old and severely deconditioned and are thus likely to benefit from cardiac rehabilitation programs. In this controlled trial, patients after TAVI will be randomized to either exercise training or usual care. The aim of our study is to compare the effect of exercise training vs. usual care on: exercise capacity vascular function parameters of heart failure, inflammation and homeostasis arrhythmogenic potential health-related quality of life

Official Title
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Exercise Training After Transcatheter Aortic Valve Implantation

Conditions
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Aortic Valve Stenosis, TAVI, Transcatheter Aortic Valve Implantation, Rehabilitation

Intervention / Treatment
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* Other: Exercise training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: TAVI procedure 3-6 months prior to inclusion, movability (100 meters or more on 6-minute walking test after TAVI), ability to attend a 12 week exercise training program, physical and clinical ability to attend the rehabilitation program at the discretion of the researcher, optimal medical treatment, pre-signed statement of a conscious and free consent to the inclusion in the clinical trial. Exclusion Criteria: contraindications for exercise training, unstable hearth (uncontrollable heart failure - New York Heart Association stage IV, dysrhythmias, uncontrollable myocardial ischemia), patient's decision to undergo TAVI despite receiving a recommendation for Surgical Aortic Valve Repair by the heart team, non-cardiac physical impairment that would prevent exercise training on stationary bike, uncontrolled pulmonary disease (FEV1 <50%), echocardiographic signs of prosthesis dysfunction according to the Valve Academic Research Consortium (valve orifice area of b1.2 cm2 plus a mean transaortic pressure gradient of ≥20 mm Hg, or a velocity of ≥3 m/s, at least moderate paravalvular regurgitation), TAVI access site complication, important peripheral vascular disease, musculoskeletal disease or central nervous system disease, which prevents exercise training on stationary bike, recent (less than 3 months) acute events or illnesses that are contraindications for exercise training.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exercise training group<br>Patient to be randomized to exercise training group will have exercise training sessions 2 times per week for a period of 12 weeks. They will undergo moderate continuous exercise training at 75% of Vo2max. | Other: Exercise training<br>* Continuous exercise training 2 times per week for a period of 12 weeks.<br>* Other names: Rehabilitation;|
| No Intervention: Usual care group<br>Patient to be randomized to usual care group will undergo standard care fo 12 weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of maximal oxygen uptake during exercise | ml/kg/min | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of flow-mediated dilatation (FMD) of the brachial artery | % flow-mediated dilatation and arterial stiffness | 3 months | 
| Change of arterial stiffness coefficient | coefficient | 3 months | 
| Change of value of blood N terminal-proBNP | ng/l | 3 months | 
| Change of value of blood D-dimer | microg/l | 3 months | 
| Change of value from-the-questionnaire-obtained quality of life | points | 3 months | 
| Change of ECG waves | Estimated with digital high-resolution ECG | 3 months | 
| Change in the result of the 6-minute walking test | metres | 3 months | 
| Change og the heart rate variability | Estimated with digital high-resolution ECG | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise training