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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
Sponsor:
Information provided by (Responsible Party):
Paul Oh, University Health Network, Toronto

Brief Summary:
Heart disease is the number one killer amongst chronic diseases around the world, and it is responsible for taking the lives of an estimated 17.5 million people each year. Exercise-based cardiac rehabilitation (CR) programs, which help heart patients improve their current health, prevent future heart problems, and improve their quality of life, are an effective strategy for lowering the risk of heart-related deaths in heart patients. CR programs currently have their patients perform moderate intensity, continuous exercise (MICE), which traditionally takes the form of walking, jogging, or cycling at a comfortable pace for 30-60 minutes. Recently, aerobic interval training (AIT), which involves performing short bouts of exercise, typically ranging from 15 seconds to four minutes at near maximal effort, followed by periods of recovery or rest, has emerged as a more effective strategy than MICE for lowering the risk of heart-related deaths in heart patients. Although these initial findings appear to hold much promise for improving CR programs in the future, it is important to recognize that women have been underrepresented or not included in these studies to date. Therefore, the goal of this study is to determine the effects of AIT versus MICE on the risk of heart-related death, blood vessel health, and brain health in women who have heart disease, and who have been referred to a six-month, outpatient CR program.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Other: AIT Group Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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:

  1. Warm Up Period: 5-10 minutes of walking performed at an intensity that will feel fairly light. Heart rate monitors and watches will be used to gauge their effort.
  2. Intervals: Between two to four 4-minute intervals of walking/jogging performed at an intensity that is close to participants' maximal effort, based on the exercise tests that were performed at the beginning of the program. These "hard intervals" will be separated by 3-minutes of active recovery performed at a very light intensity.
  3. Cool Down Period: 5 minutes of walking performed at a fairly light intensity.
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.




Primary Outcome Measures :
  1. 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).

  2. 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 [32].


Secondary Outcome Measures :
  1. 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.

  2. Quality of Life [ Time Frame: Baseline and 6 months ]
    Standard cardiac rehab medical health questionnaire will be used to capture quality of life.

  3. 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.

  4. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Post-menopausal women with CAD
  • In sinus rhythm
  • Left Ventricular Ejection fraction>35%
  • >3 weeks post myocardial infarction (MI) or percutaneous intervention (PCI)
  • >4 weeks post coronary artery bypass graft (CABG)
  • Ability to provide written and informed consent

Exclusion Criteria:

  • Any major musculoskeletal, pulmonary, or psychiatric comorbidity that precludes participation in aerobic and resistance training exercise
  • Canadian Cardiovascular Society (CCS) contraindications that present upon initial intake Cardiopulmonary Exercise Assessment (CPA), which include Class II-IV angina, significant arrhythmia, or >1mm horizontal/downsloping ST-segment depression.

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): NCT02966158


Contacts
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Contact: Leanna S Lee, MSc 416-597-3422 ext 5223 leanna.lee@uhn.ca
Contact: Susan Marzolini, PhD 416-597-3422 ext 5243 Susan.Marzolini@uhn.ca

Locations
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Canada, Ontario
University Health Network Cardiac Rumsey Centre Recruiting
Toronto, Ontario, Canada, M4G1R7
Contact: Leanna S Lee, MSc    416-597-3422 ext 5223    leanna.lee@uhn.ca   
Contact: Susan Marzolini, PhD    416-597-3422 ext 5243    Susan.Marzolini@uhn.ca   
Principal Investigator: Paul I Oh, MD, Msc         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Paul I Oh, MD, MSc University Health Network, Toronto

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Responsible Party: Paul Oh, Medical Director, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02966158     History of Changes
Other Study ID Numbers: 16-5900
First Posted: November 17, 2016    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data IPD will be shared with other researchers upon request (i.e. contacting researchers via email, phone, etc,.) once the study is complete and the data is shared and presented through publication. IPD may be used for secondary purposes, such as in meta-analyses, or in re-analyses including different comparator groups, and for the replication of results.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paul Oh, University Health Network, Toronto:
Aerobic Interval Training
Fitness
Endothelial Function
Cognition
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases