A Randomized Controlled Trial in Women With Coronary Artery Disease Investigating the Effects of Aerobic Interval Training Versus Moderate Intensity Continuous Exercise in the Standard Cardiac Rehabilitation Setting: Aerobic Exercise Capacity and Cognitive Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Aerobic Exercise Capacity
研究概览
简要总结
Heart disease is the number one killer amongst chronic diseases around the world, and it is responsible for taking the lives of an estimated 17.5 million people each year. Exercise-based cardiac rehabilitation (CR) programs, which help heart patients improve their current health, prevent future heart problems, and improve their quality of life, are an effective strategy for lowering the risk of heart-related deaths in heart patients. CR programs currently have their patients perform moderate intensity, continuous exercise (MICE), which traditionally takes the form of walking, jogging, or cycling at a comfortable pace for 30-60 minutes. Recently, aerobic interval training (AIT), which involves performing short bouts of exercise, typically ranging from 15 seconds to four minutes at near maximal effort, followed by periods of recovery or rest, has emerged as a more effective strategy than MICE for lowering the risk of heart-related deaths in heart patients. Although these initial findings appear to hold much promise for improving CR programs in the future, it is important to recognize that women have been underrepresented or not included in these studies to date. Therefore, the goal of this study is to determine the effects of AIT versus MICE on the risk of heart-related death, blood vessel health, and brain health in women who have heart disease, and who have been referred to a six-month, outpatient CR program.
详细描述
This will be the first randomized controlled trial (RCT) investigating the effects of AIT versus MICE on aerobic exercise capacity, endothelial function, and cognition, in women only, who have CAD and have been referred to the six-month, outpatient CR program at the Toronto Rehabilitation Institute (TRI)-Cardiac Rumsey Centre. Study participants will be reporting to the Rumsey Centre one day per week for a combination of supervised exercise sessions and educational seminars or workshops, and they will be performing four additional unsupervised, home-exercise sessions per week for a target total of five exercise sessions per week.
Recruitment and Sampling
Immediately after completion of a symptom-limited intake CPA, a previously identified eligible patient who would have been screened for eligibility upon her referral to the six-month, outpatient CR program at the TRI-Cardiac Rumsey Centre will be asked by either the Cardiopulmonary Exercise Technicians, or Lab Coordinator performing the initial CPA, if she would be interested in speaking to a researcher and learning more about potential participation in this research study. If the patient agrees to speak to the researcher, the researcher will meet the patient in person immediately following the CPA to explain the study and to obtain voluntary, written and informed consent if applicable. Patients will be provided with the opportunity to take the consent forms home, and to discuss participation in the study with their spouses or other family members, etc., and to take as much time is required to decide whether participation in the study is a desirable option for them.
If, and when a patient provides written and informed consent to participate in the study, she will be randomized by a computerized random number generator (operated by a blinded third party researcher) to either the six-month standard of care CR program offered at the TRI-Rumsey Centre involving MICE, or to the 6-month AIT intervention. Both the MICE and AIT arms of the study will consist of patients attending one, supervised exercise session per week at the TRI-Rumsey Centre, and they will perform four additional unsupervised home-exercise sessions per week for a total of five exercise sessions per week as the goal.
The AIT Intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Post-menopausal women with CAD
- •In sinus rhythm
- •Left Ventricular Ejection fraction>35%
- •>3 weeks post myocardial infarction (MI) or percutaneous intervention (PCI)
- •>4 weeks post coronary artery bypass graft (CABG)
- •Ability to provide written and informed consent
排除标准
- •Any major musculoskeletal, pulmonary, or psychiatric comorbidity that precludes participation in aerobic and resistance training exercise
- •Canadian Cardiovascular Society (CCS) contraindications that present upon initial intake Cardiopulmonary Exercise Assessment (CPA), which include Class II-IV angina, significant arrhythmia, or >1mm horizontal/downsloping ST-segment depression.
结局指标
主要结局
Aerobic Exercise Capacity
时间窗: Change from baseline aerobic exercise capacity at 6 months
Aerobic exercise capacity, as measured directly by VO2peak, will be measured via breath-by-breath gas exchange analysis captured by a metabolic cart (Vmax Encore, SensorMedics, Yorba Linda, CA), while a patient is performing a symptom-limited CPA using a cycle ergometer (Ergoselect 200P, Ergoline, Bitz, Germany).
Cognitive Function
时间窗: Change from baseline cognitive function at 6 months
A battery of neuropsychological tests were chosen to assess cognitive function based on harmonized standards in accordance with the National Institute of Neurological Disorders and Stroke and Canadian Stroke Network \[32\].
次要结局
- Cardiovascular Risk Profile(Baseline and 6 months)
- Endothelial Function(Baseline, 3 months, and 6 months)
- Quality of Life(Baseline and 6 months)
- Adherence to Exercise(Throughout 6 month exercise program)
研究者
Paul Oh
Medical Director
University Health Network, Toronto