Atrial Fibrillation Trial to Evade Recurrence: effectS of Hiit Before electrO-Cardioversion
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Feasibility - recruitment rates
研究概览
简要总结
This is a study looking at the feasibility of conducting a larger definitive research trial looking at the effectiveness of high intensity interval training in individuals who are scheduled for electro-cardioversion. Usual care for these participants is to go home and continue with their typical daily routine. The investigators will test whether participating in 3-weeks of thrice-weekly high intensity interval training before electro-cardioversion can lengthen the time to recurrence of atrial fibrillation after electro-cardioversion in these individuals. Participants will be asked to come to the University of Ottawa Heart Institute for a baseline visit at which fitness (cycle ergometer), body composition (weight, height, waist circumference and percentage body fat), heart rate variability and habitual exercise levels will be measured. Participants will then be randomized to either the exercise group or the usual care group. Those randomized to the usual care group will go home for 3-weeks and continue with their typical daily routine. Those randomized to the exercise group will return to the Heart Institute three times per week for 3-weeks to participate in a high intensity interval training program prior to their electro-cardioversion. All participants will be asked to measure daily heart rate and rhythm using the AliveCor system which is compatible with their Smartphones, for up to 12-months following their electro-cardioversion. All participants will be asked to return at 3-weeks (and prior to their electro-cardioversion) to measure fitness (cycle ergometer), body composition (weight, height, waist circumference and percentage body fat), and habitual exercise levels. The entire study should last approximately 24-months. Participants will be involved for 52-weeks. The investigators are looking to recruit 20 participants total for the feasibility trial. The investigators hypothesize that recruitment rates, drop-out rates, and adherence to the intervention will support a larger definitive trial.
详细描述
This is a study looking at the feasibility of conducting a larger definitive research trial looking at the effectiveness of high intensity interval training on lengthening time to recurrence of persistent atrial fibrillation in individuals who are scheduled for electro-cardioversion. Usual care for these participants is to go home and continue with their typical daily routine until their scheduled cardioversion. The investigators will test whether participating in 3-weeks of thrice-weekly high intensity interval training before electro-cardioversion can lengthen the time to recurrence of atrial fibrillation after electro-cardioversion in these individuals. Participants will be asked to come to the University of Ottawa Heart Institute for a baseline visit at which fitness (cycle ergometer), body composition (weight, height, waist circumference and percentage body fat), and habitual exercise levels will be measured. Participants will then be randomized to either the exercise group or the usual care group. Those randomized to the usual care group will go home for 3-weeks and continue with their typical daily routine. Those randomized to the exercise group will return to the Heart Institute three times per week for 3-weeks to participate in a high intensity interval training cycle ergometer program prior to their electro-cardioversion. All participants will be asked to return at 3-weeks (and prior to their electro-cardioversion) to measure fitness (cycle ergometer), body composition (weight, height, waist circumference and percentage body fat), and habitual exercise levels. Following the electro-cardioversion, all participants will be asked to measure daily heart rate and rhythm using the AliveCor system which is compatible with their Smartphones/tablets/iPads, for up to 12-months or until they return to persistent atrial fibrillation. The entire study should last approximately 24-months. Participants will be involved for a maximum of 52-weeks. The investigators are looking to recruit a total of 20 participants for the feasibility trial. The investigators hypothesize that recruitment rates, drop-out rates, and adherence to the intervention will support a larger definitive trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persistent atrial fibrillation
- •Eligible and scheduled for electro-cardioversion at UOHI
- •Rate controlled with a resting ventricular rate of equal to or less than 100bpm
- •Between 18-85 years of age
- •Owns a Smartphone
- •Physically able to participate in exercise
- •Willing and able to provide written, informed consent
- •Willing and able to return for follow-up visits
- •Willing and able to provide daily ECG recordings using the AliveCor system for the duration of the study.
排除标准
- •Participating in routine exercise training (more than two times per week) in the past 3 months
- •Atrial Flutter secondary to ablation
- •Unstable angina
- •Diagnosed with severe mitral or aortic stenosis, hypertrophic obstructive cardiomyopathy
- •Pregnant, lactating or planning to become pregnant during the study period
- •Diagnosed with rheumatic heart disease
结局指标
主要结局
Feasibility - recruitment rates
时间窗: 52-weeks
recruitment rates
Feasibility - adherence to study procedures
时间窗: 52-weeks
adherence to study procedures including daily AliveCor measures
Feasibility - loss to follow-up and drop-out rates
时间窗: 52-weeks
loss to follow-up and drop-out rates
Feasibility - reasons for drop-out
时间窗: 52-weeks
reasons for drop-out
Feasibility - attendance at thrice-weekly HIIT sessions
时间窗: 3-weeks
attendance at thrice-weekly HIIT sessions
次要结局
- Body Mass Index(3-weeks)
- Clinical outcomes(3-weeks)
- Weight(3-weeks)
- Physical Activity levels(3-weeks)
- Fitness(3-weeks)
- Time to recurrence of atrial fibrillation(Up to 52 weeks after electro-cardioversion.)
- Waist Circumference(3-weeks)
- Body Fat(3-weeks)