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

Cambridge Cardiac Care Centre

Status: Unknown

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

Treatments: Behavioral: Moderate Intensity Continuous Training; Behavioral: Text Message Reminders; Behavioral: BURST physical activity

Study type: Interventional

Funder types: Other

Identifiers

NCT03103854

CCCBE1418

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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500 participants in 4 patient groups

Control

Active Comparator group

Description:

Patients in the "Control" arm of the study performed Moderate Intensity Continuous Training (MICT) and did not receive text message reminders.

Treatment:

Behavioral: Moderate Intensity Continuous Training

BURST

Experimental group

Description:

Patients in the "BURST" arm of the study performed BURST physical activity and did not receive text message reminders

Treatment:

Behavioral: BURST physical activity

Text Message Reminders

Experimental group

Description:

Patients in the "Text Message Reminders" arm of the study performed Moderate Intensity Continuous Training and received text message reminders.

Treatment:

Behavioral: Text Message Reminders

Behavioral: Moderate Intensity Continuous Training

BURST and Text Message Reminders

Experimental group

Description:

Patients in the "BURST and Text Message Reminders" arm of the study performed Burst physical activity and received text message reminders

Treatment:

Behavioral: BURST physical activity

Behavioral: Text Message Reminders