Novel Strategies to Improve Cardiometabolic Status and Adherence to Exercise Regimens in Patients at High Risk for Cardiovascular Disease
BURST
The Impact of Novel Strategies to Improve Cardiometabolic Status and Adherence to Exercise Regimens in Patients at High Risk for Cardiovascular Disease
1 other identifier
interventional
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started Jan 2014
Longer than P75 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 28, 2017
CompletedFirst Posted
Study publicly available on registry
April 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedJuly 26, 2018
July 1, 2018
6 years
March 28, 2017
July 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HbA1C at 12 months
Hemoglobin A1C blood test
12 months
Secondary Outcomes (12)
LDL at 3 months
3 months
LDL at 12 months
12 months
HDL at 3 months
3 months
HDL at 12 months
12 months
Triglycerides at 3 months
3 months
- +7 more secondary outcomes
Study Arms (4)
Control
ACTIVE COMPARATORPatients in the "Control" arm of the study performed Moderate Intensity Continuous Training (MICT) and did not receive text message reminders.
BURST
EXPERIMENTALPatients in the "BURST" arm of the study performed BURST physical activity and did not receive text message reminders
Text Message Reminders
EXPERIMENTALPatients in the "Text Message Reminders" arm of the study performed Moderate Intensity Continuous Training and received text message reminders.
BURST and Text Message Reminders
EXPERIMENTALPatients in the "BURST and Text Message Reminders" arm of the study performed Burst physical activity and received text message reminders
Interventions
BURST is a novel exercise regimen consisting of three daily periods of 10 minutes of high intensity physical activity spread throughout the day.
Patients were sent daily text message reminders to remind them to exercise.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cambridge Cardiac Rehab
Cambridge, Ontario, N1R 6V6, Canada
Related Publications (5)
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.
PMID: 18256393BACKGROUNDKnowler 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.
PMID: 11832527BACKGROUNDArmstrong 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.
PMID: 25742772BACKGROUNDFrancois 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.
PMID: 25717277BACKGROUNDThakkar 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.
PMID: 26831740BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Avinash Pandey
Western University, Canada
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2017
First Posted
April 6, 2017
Study Start
January 1, 2014
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
July 26, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share