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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Aerobic Exercise Capacity
Study Overview
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.
Detailed Description
This will be the first randomized controlled trial (RCT) investigating the effects of AIT versus MICE on aerobic exercise capacity, endothelial function, and cognition, in women only, who have CAD and have been referred to the six-month, outpatient CR program at the Toronto Rehabilitation Institute (TRI)-Cardiac Rumsey Centre. Study participants will be reporting to the Rumsey Centre one day per week for a combination of supervised exercise sessions and educational seminars or workshops, and they will be performing four additional unsupervised, home-exercise sessions per week for a target total of five exercise sessions per week.
Recruitment and Sampling
Immediately after completion of a symptom-limited intake CPA, a previously identified eligible patient who would have been screened for eligibility upon her referral to the six-month, outpatient CR program at the TRI-Cardiac Rumsey Centre will be asked by either the Cardiopulmonary Exercise Technicians, or Lab Coordinator performing the initial CPA, if she would be interested in speaking to a researcher and learning more about potential participation in this research study. If the patient agrees to speak to the researcher, the researcher will meet the patient in person immediately following the CPA to explain the study and to obtain voluntary, written and informed consent if applicable. Patients will be provided with the opportunity to take the consent forms home, and to discuss participation in the study with their spouses or other family members, etc., and to take as much time is required to decide whether participation in the study is a desirable option for them.
If, and when a patient provides written and informed consent to participate in the study, she will be randomized by a computerized random number generator (operated by a blinded third party researcher) to either the six-month standard of care CR program offered at the TRI-Rumsey Centre involving MICE, or to the 6-month AIT intervention. Both the MICE and AIT arms of the study will consist of patients attending one, supervised exercise session per week at the TRI-Rumsey Centre, and they will perform four additional unsupervised home-exercise sessions per week for a total of five exercise sessions per week as the goal.
The AIT Intervention
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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:
- 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.
- 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.
- Cool Down Period: 5 minutes of walking performed at a fairly light intensity.
Intervention: AIT Group (Other)
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.
Outcomes
Primary Outcomes
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 \[32\].
Secondary Outcomes
- Cardiovascular Risk Profile(Baseline and 6 months)
- Endothelial Function(Baseline, 3 months, and 6 months)
- Quality of Life(Baseline and 6 months)
- Adherence to Exercise(Throughout 6 month exercise program)
Investigators
Paul Oh
Medical Director
University Health Network, Toronto