Exercise Training in Women With Heart Disease: A Randomized Controlled Trial
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
- Change in Exercise capacity
研究概览
简要总结
Coronary heart disease (CHD) is a leading cause of premature death in Canadian women. Women who suffer an acute coronary event are more likely than men to be physically inactive, have lower exercise capacity, and die in the next year. The standard cardiac rehabilitation (CR) programs do not meet women's needs. There is a need to address these issues to increase participation in CR. 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) on exercise capacity and quality of life in women with CHD. Positive results of this study will fill the gap in knowledge in exercise training, levels of motivation, self-efficacy and enjoyment following HIIT vs. MICE in women with CHD.
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
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with CHD (e.g. CABG or PCI at least 4 weeks but less than 12 weeks post event or procedure; acute myocardial infarction; or, stable angina with corroborating evidence of CHD);
- •Patient is able to perform a symptom-limited CPET (this is needed to determine peak HR for the exercise training prescription); and,
- •Patient is able to read and understand English or French.
排除标准
- •Patient is currently participating in routine exercise training (>2x/week) (this may reduce the impact of the program on outcomes);
- •Patient has: a ventricular ejection fraction <45%; unstable angina; or established diagnosis of chronic obstructive pulmonary disease, severe mitral or aortic stenosis, or hypertrophic obstructive cardiomyopathy (this may interfere with the ability to engage in MICE or HIIT);
- •Patient has unmanaged psychiatric illness (e.g. active psychosis, suicidal ideation) or cognitive impairment (this may confound improvements in physical and health outcomes);
- •Patient does not have internet connection;
- •Patient is unable to provide written informed consent; or
- •Patient is unwilling or unable to return for follow-up visits at 12 and 26 weeks.
- •Patient is unwilling to be randomized to HIIT or MICE
结局指标
主要结局
Change in Exercise capacity
时间窗: from baseline to week-6 and from baseline to week-12
will be measured using a gold standard symptom-limited, cardiopulmonary exercise test (CPET) on an electronically braked cycle ergometer. Gas exchange will be monitored continuously; the highest rate of oxygen uptake achieved (i.e. peak VO2 in mL/kg/min) during the last minute of the CPET will represent exercise capacity.
次要结局
- physical and mental health(from baseline to 12 weeks and baseline to 26 weeks)
- Depression(from baseline to 12 weeks and baseline to 26 weeks)
- Vital Signs - Resting Heart Rate(from baseline to 12 weeks and baseline to 26 weeks)
- Self-determined motivation for exercise(from baseline to 12 weeks and baseline to 26 weeks)
- Disease-specific Quality of Life, global health, physical and emotional health(from baseline to 12 weeks and baseline to 26 weeks)
- Physical activity enjoyment(from baseline to 12 weeks and baseline to 26 weeks)
- Gender - TMF(from baseline to 12 weeks and baseline to 26 weeks)
- Vital Signs - Resting Blood Pressure(from baseline to 12 weeks and baseline to 26 weeks)
- COVID-19 Signs and Symptoms, Complications and Treatments(from baseline to 12 weeks and baseline to 26 weeks)
- body composition - BMI(from baseline to 12 weeks and baseline to 26 weeks)
- body composition - Waist circumference(from baseline to 12 weeks and baseline to 26 weeks)
- Overall self-efficacy for exercise(from baseline to 12 weeks and baseline to 26 weeks)
- Anxiety(from baseline to 12 weeks and baseline to 26 weeks)
- body composition - BIA(from baseline to 12 weeks and baseline to 26 weeks)
- Gender - Genesis-Praxy(from baseline to 12 weeks and baseline to 26 weeks)
研究者
Jennifer Reed
Principal Investigator
Ottawa Heart Institute Research Corporation