Clinical trial NCT04781504: Exercise Training in Women With Heart Disease
Official title: Exercise Training in Women With Heart Disease: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Coronary Heart Disease
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Exercise capacity
timeFrame: from baseline to week-6 and from baseline to week-12
Secondary outcomes:
measure: physical and mental health
timeFrame: from baseline to 12 weeks and baseline to 26 weeks
measure: Disease-specific Quality of Life, global health, physical and emotional health
timeFrame: from baseline to 12 weeks and baseline to 26 weeks
measure: Anxiety
timeFrame: from baseline to 12 weeks and baseline to 26 weeks
measure: Depression
timeFrame: from baseline to 12 weeks and baseline to 26 weeks
measure: body composition - BMI
timeFrame: from baseline to 12 weeks and baseline to 26 weeks
measure: body composition - Waist circumference
timeFrame: from baseline to 12 weeks and baseline to 26 weeks
measure: body composition - BIA
timeFrame: from baseline to 12 weeks and baseline to 26 weeks
measure: Vital Signs - Resting Blood Pressure
timeFrame: from baseline to 12 weeks and baseline to 26 weeks
measure: Vital Signs - Resting Heart Rate
timeFrame: from baseline to 12 weeks and baseline to 26 weeks
measure: Self-determined motivation for exercise
timeFrame: from baseline to 12 weeks and baseline to 26 weeks
measure: Overall self-efficacy for exercise
timeFrame: from baseline to 12 weeks and baseline to 26 weeks
measure: Physical activity enjoyment
timeFrame: from baseline to 12 weeks and baseline to 26 weeks
measure: Gender - TMF
timeFrame: from baseline to 12 weeks and baseline to 26 weeks
measure: Gender - Genesis-Praxy
timeFrame: from baseline to 12 weeks and baseline to 26 weeks
measure: COVID-19 Signs and Symptoms, Complications and Treatments
timeFrame: from baseline to 12 weeks and baseline to 26 weeks
Other outcomes:
measure: Physical activity levels
timeFrame: from baseline to 12 weeks and baseline to 26 weeks
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Jennifer Reed, PhD
role: PRINCIPAL_INVESTIGATOR
References: