Exercise Training in Women With Heart Disease

Cardiovascular Diseases Clinical Trial

— EXCEED  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04781504
• Other study ID #: 20200732-01H
• Status: Recruiting
• Phase: N/A
• Start date: April 5, 2021
• Est. completion date: April 30, 2024

Study information

• Verified date: September 2023
• Source: Ottawa Heart Institute Research Corporation
• Contact: Jennifer Reed, PhD
• Phone: 613-696-7392
• Email: jreed[@]ottawaheart.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 172
• Est. completion date: April 30, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Gender - Genesis-Praxy	using the Genesis-Praxy questionnaire.	from baseline to 12 weeks and baseline to 26 weeks
Secondary	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