The Impact of Novel Strategies to Improve Cardiometabolic Status and Adherence to Exercise Regimens in Patients at High Risk for Cardiovascular Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- HbA1C at 12 months
研究概览
简要总结
This is a 2x2 study examining the impacts of a novel exercise regimen and daily text message reminders in patients at high risk for cardiovascular disease. Patients participating in cardiac rehabilitation will be randomized to either moderate intensity continuous training (MICT) or a novel exercise regimen consisting of three periods of high intensity exercise, called BURST exercise. Additionally, half of the patients in each exercise group will be randomized to receive daily text message reminders to improve adherence to the prescribed exercise regimen.
详细描述
Numerous studies have demonstrated the important cardiometabolic impacts of high intensity exercise in patients at high risk for cardiovascular disease. It is also known that adherence to exercise regimens is poor within these populations. This study compares the impacts of the current standard of care, moderate intensity continuous training (MICT) to a novel exercise regimen called BURST exercise within a population of patients at high risk for cardiovascular disease. BURST exercise consists of three periods of high intensity physical activity spread throughout the day. Additionally, as mobile technologies continue to be used more to improve adherence to exercise regimens, this study also seeks to compare the impacts of text message reminders in patients prescribed each of the exercise regimens examined in this study. Thus, patients were also randomized to either receive daily text message reminders, or to receive no text message reminders.
Recruitment will be conducted at Cambridge Cardiac Rehab in Ontario, Canada. Potential study subjects are evaluated for inclusion and exclusion criteria, give written informed consent, and are randomized, in a 1:1 ratio, to either MICT or BURST exercise. Additionally, patients are then randomized in a 1:1 ratio to either receive text message reminders or not receive text message reminders.
Patients prescribed the MICT regimen will be asked to exercise for 30 minutes per day at moderate intensity, at least five days per week. Patients prescribed the BURST exercise regimen will be asked to exercise for 10 minutes per session, three times a day at high intensity, at least five days per week. Patients randomized to receive text message reminders will be sent four daily text message reminders reading: "Please remember to exercise for 30 minutes today."
Adherence to exercise regimens will be measured by daily logbooks. Patients are asked to log the times they exercised and for what duration. BRUCE protocol stress tests will be conducted for all patients at baseline (before beginning the study), after three months and after one year. Hemoglobin A1C blood tests, height and weight measurements and lipid profile blood tests will also be conducted at baseline (before the beginning of the study), after three months and after one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed type 2 diabetic patients (within the last 3 months)
- •Participating in on-site the diabetes rehabilitation program at Cambridge Cardiac Rehab
- •Deemed capable of high-intensity exercise
排除标准
- •Known or suspected cardiovascular disease
- •Diabetic end-organ damage
- •Cerebrovascular disease
- •Peripheral vascular disease
- •Arthritis
- •Joint disease
- •Taking anti-glycemic medications
- •Taking lipid lowering medications
- •Ischemia, hypoxia, arrhythmia or hemodynamic instability during a stress test
研究组 & 干预措施
Control
Patients in the "Control" arm of the study performed Moderate Intensity Continuous Training (MICT) and did not receive text message reminders.
干预措施: Moderate Intensity Continuous Training (Behavioral)
BURST
Patients in the "BURST" arm of the study performed BURST physical activity and did not receive text message reminders
干预措施: BURST physical activity (Behavioral)
Text Message Reminders
Patients in the "Text Message Reminders" arm of the study performed Moderate Intensity Continuous Training and received text message reminders.
干预措施: Text Message Reminders (Behavioral)
Text Message Reminders
Patients in the "Text Message Reminders" arm of the study performed Moderate Intensity Continuous Training and received text message reminders.
干预措施: Moderate Intensity Continuous Training (Behavioral)
BURST and Text Message Reminders
Patients in the "BURST and Text Message Reminders" arm of the study performed Burst physical activity and received text message reminders
干预措施: BURST physical activity (Behavioral)
BURST and Text Message Reminders
Patients in the "BURST and Text Message Reminders" arm of the study performed Burst physical activity and received text message reminders
干预措施: Text Message Reminders (Behavioral)
结局指标
主要结局
HbA1C at 12 months
时间窗: 12 months
Hemoglobin A1C blood test
次要结局
- Triglycerides at 12 months(12 months)
- BMI at 3 months(3 months)
- Exercise Capacity at 12 months(12 months)
- Monthly Duration of Exercise(Months 1-12)
- Triglycerides at 3 months(3 months)
- LDL at 12 months(12 months)
- BMI at 12 months(12 months)
- HbA1C at 3 months(3 months)
- LDL at 3 months(3 months)
- HDL at 3 months(3 months)
- HDL at 12 months(12 months)
- Exercise Capacity at 3 months(3 months)