Exercise Training in Patients With Persistent or Permanent Atrial Fibrillation - a Multi-centre Randomized Controlled Trial
概览
- 阶段
- 不适用
- 干预措施
- standard care
- 疾病 / 适应症
- Atrial Fibrillation
- 发起方
- Ottawa Heart Institute Research Corporation
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Changes in exercise capacity measured by VO2peak on a symptom-limited cardiopulmonary exercise test (CPET).
- 状态
- 招募中
- 最后更新
- 上个月
概览
简要总结
The main purpose of this project is to evaluate the effects of high-intensity interval training (HIIT) compared to moderate-intensity continuous exercise training (MICE) and standard care on exercise capacity and quality of life in patients with persistent or permanent atrial fibrillation. Positive findings are vitally important for these patients, given the condition's substantial morbidity, mortality and high economic costs.
详细描述
Recommended standards of care do not include the prescription of exercise to target and ameliorate the progressive health decline and overall feeling of well-being in patients with atrial fibrillation. Recent Standards for the Provision of Cardiac Rehabilitation of Ontario are calling for the consideration for referral and enrollment of patients with atrial fibrillation in cardiovascular rehabilitation - evidence is needed to support and confirm these efforts. The main purpose of this project is to evaluate the effects of high-intensity interval training (HIIT) compared to moderate-intensity continuous exercise training (MICE) and standard care on exercise capacity and quality of life in patients with persistent or permanent atrial fibrillation. Positive results from this study will identify a new intervention that: produces important improvements in patient-rated clinical, behavioural and exercise outcomes; provides mechanistic insight into the role of exercise training in the management of atrial fibrillation; requires minimal equipment; and, is appealing to patients with atrial fibrillation.
研究者
入排标准
入选标准
- •persistent or permanent atrial fibrillation;
- •rate controlled with a resting ventricular rate of equal to or less than 100 bpm;
- •able to perform a symptom-limited exercise test;
- •at least 40 years of age (i.e. participants must be 40 years or older);
排除标准
- •currently participating in routine exercise training (more than two times per week);
- •unstable angina;
- •diagnosed severe mitral or aortic stenosis;
- •diagnosed hypertrophic obstructive cardiomyopathy with significant obstruction;
- •pregnant, lactating or planning to become pregnant during the study period;
- •unable to provide written, informed consent, or
- •unwilling or unable to return for follow up at week 12.
研究组 & 干预措施
standard care
Participants do not participate in a on site structured exercise training program.
standard care + MICE
standard care + moderate-intensity continuous exercise training (MICE)
干预措施: standard care + moderate-intensity continuous exercise training
standard care + HIIT
standard care + high-intensity interval training (HIIT)
干预措施: standard care + high-intensity interval training
结局指标
主要结局
Changes in exercise capacity measured by VO2peak on a symptom-limited cardiopulmonary exercise test (CPET).
时间窗: baseline to 12 weeks
Changes in exercise capacity measured by VO2peak on a symptom-limited cardiopulmonary exercise test (CPET) from baseline to 12 weeks.
Changes in quality of life measured by the physical component summary (PCS) measure of the Short Form 36 Health Survey Questionnaire (SF-36).
时间窗: baseline to 12 weeks
Changes in quality of life measured by the physical component summary (PCS) measure of the Short Form 36 Health Survey Questionnaire (SF-36) from baseline to 12 weeks.
次要结局
- Changes in blood biomarker concentrations (participants at the University of Ottawa Heart Institute site only).(baseline to 12 weeks)
- Changes in symptom burden measured by the Canadian Cardiovascular Society Severity of Atrial Fibrillation Scale.(baseline to 12 weeks)
- Changes in lower body muscular fitness measured by standard load tests.(baseline to 12 weeks)
- Changes in volume and intensity of exercise measured by self-report (exercise logs).(baseline to 12 weeks)
- Changes in quality of life measured by the mental component summary (MCS) measure of the Short Form 36 Health Survey Questionnaire (SF-36).(baseline to 12 weeks)
- Changes in heart rate control measured by 24-hour Holter ECG recordings and ECG recordings at each CPET.(baseline to 12 weeks)
- Changes atrial fibrillation specific quality of life measured by the University of Toronto Atrial Fibrillation Severity Scale (AFSS).(baseline to 12 weeks)
- Changes in self reported sleep patterns measured by the 7-day sleep diary.(baseline to 12 weeks)
- Changes atrial fibrillation specific quality of life measured by the Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT).(baseline to 12 weeks)
- Changes in volume and intensity of exercise measured directly by accelerometer.(baseline to 12 weeks)
- Changes in self-reported symptom frequency and severity measured by the 7-day symptom diary.(baseline to 12 weeks)