Aortic Valve Stenosis, Rehabilitation, TAVI, Transcatheter Aortic Valve Implantation
Conditions
Keywords
exercise training
Brief summary
In this prospective, controlled trial, patient after TAVI will be randomized to either exercise training or usual care group.
Detailed description
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: 1. exercise capacity 2. vascular function 3. parameters of heart failure, inflammation and homeostasis 4. arrhythmogenic potential 5. health-related quality of life
Interventions
OTHERExercise training
Continuous exercise training 2 times per week for a period of 12 weeks.
Sponsors
University Medical Centre Ljubljana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of maximal oxygen uptake during exercise | 3 months | ml/kg/min |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of flow-mediated dilatation (FMD) of the brachial artery | 3 months | % flow-mediated dilatation and arterial stiffness |
| Change of arterial stiffness coefficient | 3 months | coefficient |
| Change of value of blood N terminal-proBNP | 3 months | ng/l |
| Change of value of blood D-dimer | 3 months | microg/l |
| Change of ECG waves | 3 months | Estimated with digital high-resolution ECG |
| Change in the result of the 6-minute walking test | 3 months | metres |
| Change og the heart rate variability | 3 months | Estimated with digital high-resolution ECG |
| Change of value from-the-questionnaire-obtained quality of life | 3 months | points |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change of heart rate recovery | 3 months | beats/min |
Countries
Slovenia
Outcome results
None listed