Clinical trial NCT03103854: Novel Strategies to Improve Cardiometabolic Status and Adherence to Exercise Regimens in Patients at High Risk for Cardiovascular Disease
Official title: The Impact of Novel Strategies to Improve Cardiometabolic Status and Adherence to Exercise Regimens in Patients at High Risk for Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Myocardial Infarction
Coronary Artery Disease
Atrial Fibrillation
Congestive Heart Failure
Keywords: Exercise
Secondary Prevention
Diabetes
Rehabilitation
Lead sponsor: Cambridge Cardiac Care Centre
Sponsor class: OTHER
First posted: 2017-04-06
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: HbA1C at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: LDL at 3 months
timeFrame: 3 months
measure: LDL at 12 months
timeFrame: 12 months
measure: HDL at 3 months
timeFrame: 3 months
measure: HDL at 12 months
timeFrame: 12 months
measure: Triglycerides at 3 months
timeFrame: 3 months
measure: Triglycerides at 12 months
timeFrame: 12 months
measure: BMI at 3 months
timeFrame: 3 months
measure: BMI at 12 months
timeFrame: 12 months
measure: Exercise Capacity at 3 months
timeFrame: 3 months
measure: Exercise Capacity at 12 months
timeFrame: 12 months
measure: Monthly Duration of Exercise
timeFrame: Months 1-12
measure: HbA1C at 3 months
timeFrame: 3 months
Other outcomes:
Locations:
city: Cambridge
country: Canada
facility: Cambridge Cardiac Rehab
state: Ontario
Study officials:
affiliation: Western University, Canada
name: Avinash Pandey
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. doi: 10.1056/NEJMoa012512.
citation: 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.
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.
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.