Exercise Training After Transcatheter Aortic Valve Implantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change of maximal oxygen uptake during exercise
研究概览
简要总结
In this prospective, controlled trial, patient after TAVI will be randomized to either exercise training or usual care group.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Exercise training group
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.
干预措施: Exercise training (Other)
Usual care group
Patient to be randomized to "usual care group" will undergo standard care fo 12 weeks.
结局指标
主要结局
Change of maximal oxygen uptake during exercise
时间窗: 3 months
ml/kg/min
次要结局
- Change og the heart rate variability(3 months)
- Change of value of blood N terminal-proBNP(3 months)
- Change of value of blood D-dimer(3 months)
- Change of value from-the-questionnaire-obtained quality of life(3 months)
- Change in the result of the 6-minute walking test(3 months)
- Change of arterial stiffness coefficient(3 months)
- Change of ECG waves(3 months)
- Change of flow-mediated dilatation (FMD) of the brachial artery(3 months)
研究者
Borut Jug
prof. Borut Jug, MD, PhD
University Medical Centre Ljubljana