NCT03103854

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Cambridge Cardiac Care Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
BEHAVIORAL	BURST physical activity	BURST is a novel exercise regimen consisting of three daily periods of 10 minutes of high intensity physical activity spread throughout the day.
BEHAVIORAL	Text Message Reminders	Patients were sent daily text message reminders to remind them to exercise.
BEHAVIORAL	Moderate Intensity Continuous Training	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.

Timeline

• Start date: 2014-01-01
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2017-04-06
• Last updated: 2018-07-26

Locations

1 site across 1 country: Canada