Novel Strategies to Improve Cardiometabolic Status and Adherence to Exercise Regimens in Patients at High Risk for Cardiovascular Disease
NCT ID: NCT03103854
Last Updated: 2018-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
500 participants
INTERVENTIONAL
2014-01-01
2019-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
NONE
Study Groups
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Control
Patients in the "Control" arm of the study performed Moderate Intensity Continuous Training (MICT) and did not receive text message reminders.
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.
BURST
Patients in the "BURST" arm of the study performed BURST physical activity and did not receive text message reminders
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 in the "Text Message Reminders" arm of the study performed Moderate Intensity Continuous Training and received text message reminders.
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.
BURST and Text Message Reminders
Patients in the "BURST and Text Message Reminders" arm of the study performed Burst physical activity and received text message reminders
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participating in on-site the diabetes rehabilitation program at Cambridge Cardiac Rehab
* Deemed capable of high-intensity exercise
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Cambridge Cardiac Care Centre
OTHER
Responsible Party
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Principal Investigators
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Avinash Pandey
Role: PRINCIPAL_INVESTIGATOR
Western University, Canada
Locations
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Cambridge Cardiac Rehab
Cambridge, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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CCCBE1418
Identifier Type: -
Identifier Source: org_study_id
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