Novel Strategies to Improve Cardiometabolic Status and Adherence to Exercise Regimens in Patients at High Risk for Cardiovascular Disease
- Conditions
- Diabetes Mellitus, Type 2Congestive Heart FailureCoronary Artery DiseaseMyocardial InfarctionAtrial Fibrillation
- Interventions
- Behavioral: Moderate Intensity Continuous TrainingBehavioral: BURST physical activityBehavioral: Text Message Reminders
- Registration Number
- NCT03103854
- Lead Sponsor
- Cambridge Cardiac Care Centre
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 500
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Control Moderate Intensity Continuous Training Patients in the "Control" arm of the study performed Moderate Intensity Continuous Training (MICT) and did not receive text message reminders. BURST BURST physical activity Patients in the "BURST" arm of the study performed BURST physical activity and did not receive text message reminders Text Message Reminders Text Message Reminders Patients in the "Text Message Reminders" arm of the study performed Moderate Intensity Continuous Training and received text message reminders. BURST and Text Message Reminders Text Message Reminders Patients in the "BURST and Text Message Reminders" arm of the study performed Burst physical activity and received text message reminders BURST and Text Message Reminders BURST physical activity Patients in the "BURST and Text Message Reminders" arm of the study performed Burst physical activity and received text message reminders Text Message Reminders Moderate Intensity Continuous Training Patients in the "Text Message Reminders" arm of the study performed Moderate Intensity Continuous Training and received text message reminders.
- Primary Outcome Measures
Name Time Method HbA1C at 12 months 12 months Hemoglobin A1C blood test
- Secondary Outcome Measures
Name Time Method Exercise Capacity at 12 months 12 months Timed number of minutes achieved on a Bruce Protocol treadmill stress test
Monthly Duration of Exercise Months 1-12 Average number of minutes of exercise logged by patients in daily logbooks
Triglycerides at 12 months 12 months Measured Triglycerides from blood tests
BMI at 3 months 3 months Calculated Body Mass Index based on height and weight measurements
Triglycerides at 3 months 3 months Measured Triglycerides from blood tests
LDL at 12 months 12 months Calculated Low Density Lipoprotein from blood tests
BMI at 12 months 12 months Calculated Body Mass Index based on height and weight measurements
HbA1C at 3 months 3 months Hemoglobin A1C blood test
LDL at 3 months 3 months Calculated Low Density Lipoprotein from blood tests
HDL at 3 months 3 months Measured High Density Lipoprotein from blood tests
HDL at 12 months 12 months Measured High Density Lipoprotein from blood tests
Exercise Capacity at 3 months 3 months Timed number of minutes achieved on a Bruce Protocol treadmill stress test
Trial Locations
- Locations (1)
Cambridge Cardiac Rehab
🇨🇦Cambridge, Ontario, Canada