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

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ClinicalTrials.gov Identifier: NCT03103854
Recruitment Status : Recruiting
First Posted : April 6, 2017
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
Cambridge Cardiac Care Centre

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Myocardial Infarction Coronary Artery Disease Atrial Fibrillation Congestive Heart Failure Behavioral: BURST physical activity Behavioral: Text Message Reminders Behavioral: Moderate Intensity Continuous Training Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Impact of Novel Strategies to Improve Cardiometabolic Status and Adherence to Exercise Regimens in Patients at High Risk for Cardiovascular Disease
Actual Study Start Date : January 1, 2014
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control
Patients in the "Control" arm of the study performed Moderate Intensity Continuous Training (MICT) and did not receive text message reminders.
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.
Other Name: MICT

Experimental: BURST
Patients in the "BURST" arm of the study performed BURST physical activity and did not receive text message reminders
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.
Other Name: Exercise Snacks

Experimental: Text Message Reminders
Patients in the "Text Message Reminders" arm of the study performed Moderate Intensity Continuous Training and received text message reminders.
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.
Other Name: MICT

Experimental: 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
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.
Other Name: Exercise Snacks

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




Primary Outcome Measures :
  1. HbA1C at 12 months [ Time Frame: 12 months ]
    Hemoglobin A1C blood test


Secondary Outcome Measures :
  1. LDL at 3 months [ Time Frame: 3 months ]
    Calculated Low Density Lipoprotein from blood tests

  2. LDL at 12 months [ Time Frame: 12 months ]
    Calculated Low Density Lipoprotein from blood tests

  3. HDL at 3 months [ Time Frame: 3 months ]
    Measured High Density Lipoprotein from blood tests

  4. HDL at 12 months [ Time Frame: 12 months ]
    Measured High Density Lipoprotein from blood tests

  5. Triglycerides at 3 months [ Time Frame: 3 months ]
    Measured Triglycerides from blood tests

  6. Triglycerides at 12 months [ Time Frame: 12 months ]
    Measured Triglycerides from blood tests

  7. BMI at 3 months [ Time Frame: 3 months ]
    Calculated Body Mass Index based on height and weight measurements

  8. BMI at 12 months [ Time Frame: 12 months ]
    Calculated Body Mass Index based on height and weight measurements

  9. Exercise Capacity at 3 months [ Time Frame: 3 months ]
    Timed number of minutes achieved on a Bruce Protocol treadmill stress test

  10. Exercise Capacity at 12 months [ Time Frame: 12 months ]
    Timed number of minutes achieved on a Bruce Protocol treadmill stress test

  11. Monthly Duration of Exercise [ Time Frame: Months 1-12 ]
    Average number of minutes of exercise logged by patients in daily logbooks

  12. HbA1C at 3 months [ Time Frame: 3 months ]
    Hemoglobin A1C blood test



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103854


Contacts
Contact: Avinash Pandey 2267502167 apandey4@uwo.ca
Contact: A. Shekhar Pandey, BSc, MD 5195906127 pandey@rogers.com

Locations
Canada, Ontario
Cambridge Cardiac Rehab Recruiting
Cambridge, Ontario, Canada, N1R 6V6
Contact: A. Shekhar Pandey, BSc, MD    5195906127    pandey@rogers.com   
Contact: M. Michelle Pandey, B Pharm    (519) 624-3511    michellepandey@rogers.com   
Principal Investigator: Avinash Pandey         
Sponsors and Collaborators
Cambridge Cardiac Care Centre
Investigators
Principal Investigator: Avinash Pandey University of Western Ontario, Canada

Publications:
Responsible Party: Cambridge Cardiac Care Centre
ClinicalTrials.gov Identifier: NCT03103854     History of Changes
Other Study ID Numbers: CCCBE1418
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cambridge Cardiac Care Centre:
Exercise
Secondary Prevention
Diabetes
Rehabilitation

Additional relevant MeSH terms:
Diabetes Mellitus
Heart Failure
Atrial Fibrillation
Infarction
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Arrhythmias, Cardiac
Pathologic Processes
Ischemia
Necrosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases