A Randomized Controlled Trial in Women With Coronary Artery Disease Investigating the Effects of Aerobic Interval Training Versus Moderate Intensity Continuous Exercise (CAT vs MICE)
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|ClinicalTrials.gov Identifier: NCT02966158|
Recruitment Status : Recruiting
First Posted : November 17, 2016
Last Update Posted : November 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Other: AIT Group||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Trial in Women With Coronary Artery Disease Investigating the Effects of Aerobic Interval Training Versus Moderate Intensity Continuous Exercise in the Standard Cardiac Rehabilitation Setting: Aerobic Exercise Capacity and Cognitive Function|
|Actual Study Start Date :||March 1, 2017|
|Estimated Primary Completion Date :||July 1, 2019|
|Estimated Study Completion Date :||August 2019|
Experimental: AIT Group
The AIT Group will perform usual care CR exercise for the 1st month of the program. This includes performing aerobic exercise 5 times/week and resistance training twice/week (offered 2 weeks after program start). In month two, this group will begin to perform AIT three days/week, along with two MICE and two RT sessions.
The AIT exercise protocol includes the following components:
Other: AIT Group
The AIT Group will begin with a one-month, "run-in" period where patients will perform current standard of care CR programming, which will involve traditional MICE. MICE at the Cardiac Rumsey Centre will consist of either track walking/jogging or treadmill walking/jogging for approximately 30-40 minutes, performed at an intensity of 60-80% of VO2peak, in addition to a warm-up and cool down period. In the second month of the study intervention, patients will begin to perform AIT three days per week, which involves performing 4-minute intervals at greater than 90% of peak heart rate, separated by 3-minutes of active recovery, with one of those AIT exercise sessions occurring at the Rumsey Centre under supervision, and 2 sessions per week of MICE, which will again consist of the 30-40 minutes of walking/jogging at an intensity of 60-80% of VO2peak, with an allotted warm up and cool down period.
Other Name: Aerobic Interval Training Intervention Group
No Intervention: MICE Group
This group will perform usual care CR for 6 months, which includes both resistance and aerobic exercise (MICE) training. Aerobic exercise is prescribed in the first exercise class and performed 5 times/week, the resistance training program is offered after 2 weeks in the program and performed 2 times/week. Participants will be asked to keep a record of the exercise that they do.
Resistance/Strength Training: Patients will be performing 1-2 sets of 5 to 10 resistance training exercises using a combination of hand-held dumbbells, elastic bands of varying thicknesses, as well as their own body weight for resistance.
Aerobic Training: Patients will have their aerobic exercise prescription set at an intensity and duration that will be comfortable for them, based on the tests conducted at the beginning of the program to ensure their safety.
- Aerobic Exercise Capacity [ Time Frame: Change from baseline aerobic exercise capacity at 6 months ]Aerobic exercise capacity, as measured directly by VO2peak, will be measured via breath-by-breath gas exchange analysis captured by a metabolic cart (Vmax Encore, SensorMedics, Yorba Linda, CA), while a patient is performing a symptom-limited CPA using a cycle ergometer (Ergoselect 200P, Ergoline, Bitz, Germany).
- Cognitive Function [ Time Frame: Change from baseline cognitive function at 6 months ]A battery of neuropsychological tests were chosen to assess cognitive function based on harmonized standards in accordance with the National Institute of Neurological Disorders and Stroke and Canadian Stroke Network .
- Endothelial Function [ Time Frame: Baseline, 3 months, and 6 months ]Blood vessel health is assessed by the change in flow-mediated dilation of the brachial artery.
- Quality of Life [ Time Frame: Baseline and 6 months ]Standard cardiac rehab medical health questionnaire will be used to capture quality of life.
- Cardiovascular Risk Profile [ Time Frame: Baseline and 6 months ]This will be assessed by standard blood requisition blood draw capturing lipid, cholesterol, and triglyceride levels, in addition to the measurement of anthropometrics, such as height, body mass, waist circumference, and systolic and diastolic blood pressure values.
- Adherence to Exercise [ Time Frame: Throughout 6 month exercise program ]Adherence to the exercise interventions will be captured by HR and speed data uploaded and analyzed using the Garmin Forerunner 620 GPS watch (Garmin, Olathe, KS, USA) and accompanying heart rate monitor.
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): NCT02966158
|Contact: Leanna S Lee, MSc||416-597-3422 ext firstname.lastname@example.org|
|Contact: Susan Marzolini, PhD||416-597-3422 ext 5243||Susan.Marzolini@uhn.ca|
|University Health Network Cardiac Rumsey Centre||Recruiting|
|Toronto, Ontario, Canada, M4G1R7|
|Contact: Leanna S Lee, MSc 416-597-3422 ext 5223 email@example.com|
|Contact: Susan Marzolini, PhD 416-597-3422 ext 5243 Susan.Marzolini@uhn.ca|
|Principal Investigator: Paul I Oh, MD, Msc|
|Principal Investigator:||Paul I Oh, MD, MSc||University Health Network, Toronto|