Novel Strategies to Improve Cardiometabolic Status and Adherence to Exercise Regimens in Patients at High Risk for Cardiovascular Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Impact of Novel Strategies to Improve Cardiometabolic Status and Adherence to Exercise Regimens in Patients at High Risk for Cardiovascular Disease

Conditions
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Diabetes Mellitus, Type 2, Myocardial Infarction, Coronary Artery Disease, Atrial Fibrillation, Congestive Heart Failure

Intervention / Treatment
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* Behavioral: BURST physical activity
* Behavioral: Text Message Reminders
* Behavioral: Moderate Intensity Continuous Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: This is a 2x2 of burst physical activity (BURST) vs moderate intensity continuous training (MICT) and text message reminders vs no text message reminders. Patients will be randomized to either BURST or MICT and then further randomized to either receive text message reminders or not receive text message reminders.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Patients in the Control arm of the study performed Moderate Intensity Continuous Training (MICT) and did not receive text message reminders. | Behavioral: Moderate Intensity Continuous Training<br>* This is the current standard of care for cardiac rehabilitation patients. It consists of 1 daily period of 30 minutes of moderate intensity physical activity.<br>* Other names: MICT;|
| Experimental: BURST<br>Patients in the BURST arm of the study performed BURST physical activity and did not receive text message reminders | Behavioral: BURST physical activity<br>* BURST is a novel exercise regimen consisting of three daily periods of 10 minutes of high intensity physical activity spread throughout the day.<br>* Other names: Exercise Snacks;|
| Experimental: Text Message Reminders<br>Patients in the Text Message Reminders arm of the study performed Moderate Intensity Continuous Training and received text message reminders. | Behavioral: Text Message Reminders<br>* Patients were sent daily text message reminders to remind them to exercise.<br>Behavioral: Moderate Intensity Continuous Training<br>* This is the current standard of care for cardiac rehabilitation patients. It consists of 1 daily period of 30 minutes of moderate intensity physical activity.<br>* Other names: MICT;|
| Experimental: BURST and Text Message Reminders<br>Patients in the BURST and Text Message Reminders arm of the study performed Burst physical activity and received text message reminders | Behavioral: BURST physical activity<br>* BURST is a novel exercise regimen consisting of three daily periods of 10 minutes of high intensity physical activity spread throughout the day.<br>* Other names: Exercise Snacks;Behavioral: Text Message Reminders<br>* Patients were sent daily text message reminders to remind them to exercise.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1C at 12 months | Hemoglobin A1C blood test | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL at 3 months | Calculated Low Density Lipoprotein from blood tests | 3 months | 
| LDL at 12 months | Calculated Low Density Lipoprotein from blood tests | 12 months | 
| HDL at 3 months | Measured High Density Lipoprotein from blood tests | 3 months | 
| HDL at 12 months | Measured High Density Lipoprotein from blood tests | 12 months | 
| Triglycerides at 3 months | Measured Triglycerides from blood tests | 3 months | 
| Triglycerides at 12 months | Measured Triglycerides from blood tests | 12 months | 
| BMI at 3 months | Calculated Body Mass Index based on height and weight measurements | 3 months | 
| BMI at 12 months | Calculated Body Mass Index based on height and weight measurements | 12 months | 
| Exercise Capacity at 3 months | Timed number of minutes achieved on a Bruce Protocol treadmill stress test | 3 months | 
| Exercise Capacity at 12 months | Timed number of minutes achieved on a Bruce Protocol treadmill stress test | 12 months | 
| Monthly Duration of Exercise | Average number of minutes of exercise logged by patients in daily logbooks | Months 1-12 | 
| HbA1C at 3 months | Hemoglobin A1C blood test | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation, Exercise, Secondary Prevention, Diabetes