Brief Title
Exercise Training After Transcatheter Aortic Valve Implantation
Official Title
Exercise Training After Transcatheter Aortic Valve Implantation
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
Study Type
Interventional
Primary Outcome
Change of maximal oxygen uptake during exercise
Secondary Outcome
Change of flow-mediated dilatation (FMD) of the brachial artery
Condition
Aortic Valve Stenosis
Intervention
Exercise training
Study Arms / Comparison Groups
Exercise training group
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
40
Start Date
June 18, 2019
Completion Date
December 2020
Primary Completion Date
June 2020
Eligibility Criteria
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.
Gender
All
Ages
18 Years - 99 Years
Accepts Healthy Volunteers
No
Contacts
Borut Jug, MD, PhD, +38641951672, [email protected]
Location Countries
Slovenia
Location Countries
Slovenia
Administrative Informations
NCT ID
NCT03966417
Organization ID
UKCLFitTAVI
Responsible Party
Principal Investigator
Study Sponsor
University Medical Centre Ljubljana
Study Sponsor
Borut Jug, MD, PhD, Principal Investigator, University Medical Centre Ljubljana, Slovenia
Verification Date
June 2019