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

Coronary Artery Disease Clinical Trial

— BURST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03103854
• Other study ID #: CCCBE1418
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2014
• Est. completion date: December 31, 2019

Study information

• Verified date: July 2018
• Source: Cambridge Cardiac Care Centre
• Contact: Avinash Pandey
• Phone: 2267502167
• Email: apandey4[@]uwo.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• Text Message Reminders
Patients were sent daily text message reminders to remind them to exercise.
• 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.

Locations

Country	Name	City	State
Canada	Cambridge Cardiac Rehab	Cambridge	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Cambridge Cardiac Care Centre

Country where clinical trial is conducted

Canada, 

References & Publications (5)

Armstrong MJ, Sigal RJ, Arena R, Hauer TL, Austford LD, Aggarwal S, Stone JA, Martin BJ. Cardiac rehabilitation completion is associated with reduced mortality in patients with diabetes and coronary artery disease. Diabetologia. 2015 Apr;58(4):691-8. doi: 10.1007/s00125-015-3491-1. Epub 2015 Jan 26. — View Citation

Francois ME, Little JP. Effectiveness and safety of high-intensity interval training in patients with type 2 diabetes. Diabetes Spectr. 2015 Jan;28(1):39-44. doi: 10.2337/diaspect.28.1.39. — View Citation

Gaede P, Lund-Andersen H, Parving HH, Pedersen O. Effect of a multifactorial intervention on mortality in type 2 diabetes. N Engl J Med. 2008 Feb 7;358(6):580-91. doi: 10.1056/NEJMoa0706245. — View Citation

Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. — View Citation

Thakkar J, Kurup R, Laba TL, Santo K, Thiagalingam A, Rodgers A, Woodward M, Redfern J, Chow CK. Mobile Telephone Text Messaging for Medication Adherence in Chronic Disease: A Meta-analysis. JAMA Intern Med. 2016 Mar;176(3):340-9. doi: 10.1001/jamainternmed.2015.7667. Review. — View Citation

Outcome

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