Exercise Training in Women With Heart Disease (EXCEED)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Coronary Heart Disease
• Intervention / Treatment: Behavioral: Exercise

• Study Type: Interventional
• Enrollment (Estimated): 172
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer Reed, PhD; Phone Number: 613-696-7392; Email: jreed@ottawaheart.ca
• Study Contact Backup: Name: Matheus Mistura, MSc; Phone Number: 15944 6136967000; Email: mmistura@ottawaheart.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y4W7
      • Recruiting
      • University of Ottawa Heart Institute
      • Contact: Jennifer L Reed, PhD; Phone Number: 67392 6136967392; Email: jreed@ottawaheart.ca
      • Contact: Matheus Mistura, MSc, BSc; Phone Number: 15944 6136967000; Email: mmistura@ottawaheart.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: standard care + moderate-intensity continuous exercise training; 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; 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
Experimental: standard care + high-intensity interval training; 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; 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity levels	will be measured objectively. The ActiGraph wGT3X-BT accelerometer (ActiGraph, Pensacola, Florida) will be worn over the right hip for 7 days	from baseline to 12 weeks and baseline to 26 weeks

Collaborators and Investigators

• Sponsor: Ottawa Heart Institute Research Corporation
• Investigators: Principal Investigator: Jennifer Reed, PhD, Ottawa Heart Institute Research Corporation

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2021
• Primary Completion (Estimated): January 30, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: October 30, 2020
• First Submitted That Met QC Criteria: March 1, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Estimated): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 1, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Cardiovascular Diseases
• Other Study ID Numbers: 20200732-01H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: it is not yet known if there will be a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No