Exercise Training in Women With Heart Disease

Study Overview
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Brief Summary
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Coronary heart disease (CHD) is a leading cause of premature death in Canadian women. Women who suffer an acute coronary event are more likely than men to be physically inactive, have lower exercise capacity, and die in the next year. The standard cardiac rehabilitation (CR) programs do not meet women's needs. There is a need to address these issues to increase participation in CR. The main purpose of this project is to evaluate the effects of high-intensity interval training (HIIT) compared to moderate-intensity continuous exercise training (MICE) on exercise capacity and quality of life in women with CHD. Positive results of this study will fill the gap in knowledge in exercise training, levels of motivation, self-efficacy and enjoyment following HIIT vs. MICE in women with CHD.

Official Title
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Exercise Training in Women With Heart Disease: A Randomized Controlled Trial

Conditions
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Cardiovascular Diseases, Coronary Heart Disease

Intervention / Treatment
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* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with CHD (e.g. CABG or PCI at least 4 weeks but less than 12 weeks post event or procedure; acute myocardial infarction; or, stable angina with corroborating evidence of CHD); Patient is able to perform a symptom-limited CPET (this is needed to determine peak HR for the exercise training prescription); and, Patient is able to read and understand English or French. Exclusion Criteria: Patient is currently participating in routine exercise training (>2x/week) (this may reduce the impact of the program on outcomes); Patient has: a ventricular ejection fraction <45%; unstable angina; or established diagnosis of chronic obstructive pulmonary disease, severe mitral or aortic stenosis, or hypertrophic obstructive cardiomyopathy (this may interfere with the ability to engage in MICE or HIIT); Patient has unmanaged psychiatric illness (e.g. active psychosis, suicidal ideation) or cognitive impairment (this may confound improvements in physical and health outcomes); Patient does not have internet connection; Patient is unable to provide written informed consent; or Patient is unwilling or unable to return for follow-up visits at 12 and 26 weeks. Patient is unwilling to be randomized to HIIT or MICE

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: standard care + moderate-intensity continuous exercise training<br>2 days/week Warm-up: 60-70% peak HR - 10min Training: 70-85% peak HR - 35min Cool-down: 60-70% peak HR - 15min | Behavioral: Exercise<br>* intervention groups will complete supervised virtual exercise sessions for 12 weeks using the platform preferred by the patient (Zoom care, Zoom business, Google duo, google meet, FaceTime, join.me, WhatsApp Call, etc). The appointment will be scheduled and conducted 2 days per week. The first class will be conducted on-site to teach the patient how to take vitals and to do an in-person exercise session<br>|
| Experimental: standard care + high-intensity interval training<br>2 days/week Warm-up: 60-70% peak HR - 10min Training: 85-95% peak HR - 25 minutes (4x4-minutes of high-intensity intervals interspersed with 3 minutes of low-intensity intervals) Cool-down: 60-70% peak HR - 10min | Behavioral: Exercise<br>* intervention groups will complete supervised virtual exercise sessions for 12 weeks using the platform preferred by the patient (Zoom care, Zoom business, Google duo, google meet, FaceTime, join.me, WhatsApp Call, etc). The appointment will be scheduled and conducted 2 days per week. The first class will be conducted on-site to teach the patient how to take vitals and to do an in-person exercise session<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Exercise capacity | will be measured using a gold standard symptom-limited, cardiopulmonary exercise test (CPET) on an electronically braked cycle ergometer. Gas exchange will be monitored continuously; the highest rate of oxygen uptake achieved (i.e. peak VO2 in mL/kg/min) during the last minute of the CPET will represent exercise capacity. | from baseline to week-6 and from baseline to week-12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical and mental health | physical and mental health will be measured using the Mental Health Composite Scale (MCS) and Physical Composite Scale (PCS) of the Short Form-36 questionnaire. It consists of 36 items that contribute to eight subscales summarized into a physical component summary scale (PCS) and a mental component summary scale (MCS). A higher score on a 0-100 scale indicates a better quality of life. | from baseline to 12 weeks and baseline to 26 weeks | 
| Disease-specific Quality of Life, global health, physical and emotional health | measured using the HeartQoL, a validated 14-item questionnaire that assesses patients' feelings on how heart disease affects daily functioning, providing a global-health related QoL score and physical and emotional subscales. Higher score means better quality of life. Score range from 0-3, where higher scores represents better heart quality of life. | from baseline to 12 weeks and baseline to 26 weeks | 
| Anxiety | measured using the General Anxiety and Depression-7 (GAD-7). Score ranges from 0-21 where higher scores means a more severe level of anxiety. | from baseline to 12 weeks and baseline to 26 weeks | 
| Depression | measured using the Patient Health Questionnaire (PHQ-9). Scores range from 1-27 where higher scores means higher depression severity. | from baseline to 12 weeks and baseline to 26 weeks | 
| body composition - BMI | body mass (kg) and height (cm) will be measured to calculate body mass index (kg/m^2) | from baseline to 12 weeks and baseline to 26 weeks | 
| body composition - Waist circumference | Changes in body composition from baseline to 12 weeks and baseline to 26 weeks are measured by waist circumference (cm). | from baseline to 12 weeks and baseline to 26 weeks | 
| body composition - BIA | Changes in body composition from baseline to 12 weeks and baseline to 26 weeks are measured by bioelectrical impedance (%) | from baseline to 12 weeks and baseline to 26 weeks | 
| Vital Signs - Resting Blood Pressure | changes in vital signs will be measured using resting blood pressure (mmHg) in a seated position after a 5-minute rest period on the right arm using an automated monitor (BPTru) that measures 6 times (the first will be discarded and an average of the last 5 measurements will be used for statistical analyses) at 2-minute intervals. | from baseline to 12 weeks and baseline to 26 weeks | 
| Vital Signs - Resting Heart Rate | changes in vital signs will be measured using resting heart rate (bpm) | from baseline to 12 weeks and baseline to 26 weeks | 
| Self-determined motivation for exercise | the 24-item Behavioural Regulation in Exercise questionnaire (BREQ-3) yields an overall Relative Autonomy Index (RAI) score, representing overall self-determined motivation. The scale ranges from -3 amotivation to +3 intrinsic regulation. | from baseline to 12 weeks and baseline to 26 weeks | 
| Overall self-efficacy for exercise | the 9-item Multidimensional Self-Efficacy for Exercise Scale (MSES-R) yields an overall self-efficacy for exercise score reflecting scheduling, task and coping self-efficacy. The MSES consists of nine items on a 100% confidence scale ranging from 0 = no confidence to 100 = completely confident. | from baseline to 12 weeks and baseline to 26 weeks | 
| Physical activity enjoyment | the 18-item Physical Activity Enjoyment Scale (PACES) measures the extent (on a 7-point Likert scale) to which participants enjoy doing physical activity. Overall enjoyment for physical activity score is determined by summing the items, with a range of 18-126 being possible. Higher scores indicate higher enjoyment. | from baseline to 12 weeks and baseline to 26 weeks | 
| Gender - TMF | using the Traditional Masculinity and Femininity scale (TMF). A score close to 4 refers to be moderately feminine and masculine. | from baseline to 12 weeks and baseline to 26 weeks | 
| Gender - Genesis-Praxy | using the Genesis-Praxy questionnaire. | from baseline to 12 weeks and baseline to 26 weeks | 
| COVID-19 Signs and Symptoms, Complications and Treatments | using a self-reported questionnaire. No score reported with this questionnaire | from baseline to 12 weeks and baseline to 26 weeks |