Recruiting

Cardiometabolic Strategies

Sponsor:

Cambridge Cardiac Care Centre

Code:

NCT03103854

Conditions

Diabetes Mellitus, Type 2

Myocardial Infarction

Coronary Artery Disease

Atrial Fibrillation

Congestive Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BURST physical activity

Text Message Reminders

Moderate Intensity Continuous Training

Study Details

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.

Conditions

Diabetes Mellitus, Type 2

Myocardial Infarction

Coronary Artery Disease

Atrial Fibrillation

Congestive Heart Failure

Study ID

NCT03103854

Start date

Jan 1, 2014

Status verified date

Jul, 2018

Completion date

Dec 31, 2019

Anticipated

Primary completion date

Dec 31, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Control

Patients in the "Control" arm of the study performed Moderate Intensity Continuous Training (MICT) and did not receive text message reminders.

experimental: BURST

Patients in the "BURST" arm of the study performed BURST physical activity and did not receive text message reminders

experimental: Text Message Reminders

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

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

Interventions

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.

Primary outcome measure

  • HbA1C at 12 months [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Avinash Pandey

2267502167apandey4@uwo.ca

A. Shekhar Pandey, BSc, MD

5195906127pandey@rogers.com

Locations

Cambridge Cardiac Rehab

Recruiting

Cambridge, Ontario, Canada, N1R 6V6

Contacts

A. Shekhar Pandey, BSc, MD

5195906127pandey@rogers.com

M. Michelle Pandey, B Pharm

(519) 624-3511michellepandey@rogers.com

Principal Investigator:

Avinash Pandey

More Information

Sponsor

Cambridge Cardiac Care Centre

Last update posted

Jul 26, 2018

Last verified

Jul, 2018

Keywords

  • Exercise
  • Secondary Prevention
  • Diabetes
  • Rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cambridge Cardiac Care Centre on 2018-07-26.