Feasibility of Examining Acute Responses to Exercise in Symptomatic Females and Males With Atrial Fibrillation: a Pilot Randomized Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Feasibility of the pilot study - Recruitment and consent rate
研究概览
简要总结
The main purpose of this pilot project is to measure the feasibility of conducting a randomized crossover study examining short-term changes in atrial fibrillation (AF) symptoms in symptomatic females and males with paroxysmal or persistent AF when they engage in a standard week of exercise (i.e. moderate-intensity continuous training [MICT] or high-intensity interval training [HIIT]) compared to a control week (i.e. no moderate to vigorous exercise over 7 days).
详细描述
Exercise training (e.g. 8 to 12-week exercise programs) has been shown to improve cardiorespiratory fitness and QoL, and reduce atrial fibrillation (AF) symptoms and time in AF in patients with AF. However, regular exercise participation is hindered by patient concerns regarding an increase in AF symptoms and episodes during or following an exercise session. Patients with AF also worry about potential negative consequences of increasing heart rate during exercise. This fear may be sex-specific as females report more AF symptoms at rest, experience faster heart rates during exercise and AF, and report greater symptoms of fear/anxiety than males. How exercise acutely changes AF symptoms remains to be examined.
The main purpose of this pilot project is to measure the feasibility of conducting a randomized crossover study examining short-term changes in AF symptoms in symptomatic females and males with paroxysmal or persistent AF when they engage in a standard week of exercise (i.e. moderate-intensity continuous training [MICT] or high-intensity interval training [HIIT]) compared to a control week (i.e. no moderate to vigorous exercise over 7 days). As secondary outcomes we will explore sex differences in short-term changes in AF symptoms (self reported with a questionnaire) and AF status (device measured with a wireless four-finger AliveCor KardiaMobile ECG) when symptomatic patients with AF engage in a standard week of exercise (i.e. HIIT, MICT) compared to a control week. Results from this pilot study will provide novel insight into the typical acute response to exercise in females and males with AF, and will inform appropriate approaches for the conduct of a future larger trial. This work is key to informing practitioners and patients of the typical acute exercise response in the AF population with the goal of facilitating exercise prescription and participation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Paroxysmal and Persistent AF
- •Rate controlled (resting ventricular rate <110 bpm)
- •Able to do a symptom limited exercise test
- •At least 40 years of age
- •Self-reports being symptomatic in the past 4 weeks
- •If female, self-reports being post-menopausal
- •Able to read and understand English or French
- •Agrees to sign informed consent
排除标准
- •Currently participating in routine exercise training
- •Unstable angina or uncontrolled diabetes mellitus; or established diagnosis of severe mitral or aortic stenosis, or hypertrophic obstructive cardiomyopathy with significant obstruction
- •Unable to access the Internet or a phone (iPhone and iPad require iOS version 10.0 and up, Android requires version 6.0 and up) during the study period
- •Has an automated external defibrillator, an implantable cardioverter defibrillator or other types of pacemaker
- •Unwilling or unable to complete the three conditions
- •Unable to provide written, informed consent
研究组 & 干预措施
Moderate Intensity Continuous Training (MICT)
Participants will do 3 sessions of moderate-intensity continous exercise training over 7 days
干预措施: Moderate-intensity continuous training (MICT) (Behavioral)
High Intensity Interval Training (HIIT)
Participants will do 3 sessions of high-intensity interval training over 7 days
干预措施: High-intensity interval training (HIIT) (Behavioral)
Rest
Participants will abstain from doing moderate- to high-intensity interval training over 7 days
结局指标
主要结局
Feasibility of the pilot study - Recruitment and consent rate
时间窗: Through study completion, an average of 1.5 years
Feasibility of the pilot study - Participant fidelity
时间窗: During the week of HIIT and MICT (2 weeks)
E.g. ability of participants to comply with the exercise prescription, number of exercise sessions attended
Feasibility of the pilot study - Study retention
时间窗: Through study completion, an average of 1.5 years
Dropout rate of participants
Feasibility of the pilot study - Study eligibility refinement
时间窗: Through study completion, an average of 1.5 years
Data to refine inclusion and exclusion criteria for a larger trial will be used by balancing safety, ability to complete the intervention, and generalizability (e.g. is an exclusion criterion of threshold of participation in \>2 structured exercise sessions/week sufficient or restrictive?)
Feasibility of the pilot study - Adverse events
时间窗: Through study completion, an average of 1.5 years
Side effects and adverse events during the study
次要结局
- AF status measured daily with a KardiaMobile device(3 weeks (1 week of HIIT, 1 week of MICT, 1 week fo rest))
- AF symptoms self-reported with a 7-day patient symptom questionnaire(3 weeks (1 week of HIIT, 1 week of MICT, 1 week fo rest))