A Randomized Controlled Trial in Women With Coronary Artery Disease Investigating the Effects of Aerobic Interval Training Versus Moderate Intensity Continuous Exercise

NCT02966158 | Completed

• 1 other identifier: 16-5900
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Aerobic Interval Training; Fitness; Endothelial Function; Cognition

Outcome Measures

Primary Outcomes (2)

• Aerobic Exercise Capacity

  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).

  Change from baseline aerobic exercise capacity at 6 months

• Cognitive Function

  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 \[32\].

  Change from baseline cognitive function at 6 months

Secondary Outcomes (4)

• Endothelial Function

  Baseline, 3 months, and 6 months

• Quality of Life

  Baseline and 6 months

• Cardiovascular Risk Profile

  Baseline and 6 months

• Adherence to Exercise

  Throughout 6 month exercise program

Study Arms (2)

AIT Group

EXPERIMENTAL

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

MICE Group

NO INTERVENTION

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.

Interventions

AIT Group OTHER

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.

Also known as: Aerobic Interval Training Intervention Group

AIT Group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network Cardiac Rumsey Centre

Toronto, Ontario, M4G1R7, Canada

Location

Related Publications (1)

• Lee LS, Tsai MC, Brooks D, Oh PI. Randomised controlled trial in women with coronary artery disease investigating the effects of aerobic interval training versus moderate intensity continuous exercise in cardiac rehabilitation: CAT versus MICE study. BMJ Open Sport Exerc Med. 2019 Oct 22;5(1):e000589. doi: 10.1136/bmjsem-2019-000589. eCollection 2019.

  PMID: 31749981 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Paul I Oh, MD, MSc

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: November 17, 2016
• Study Start: March 1, 2017
• Primary Completion: August 31, 2019
• Study Completion: October 22, 2019
• Last Updated: December 2, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)