Exercise Training in Women With Heart Disease

NCT ID: NCT04781504

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-05
• Study Completion Date: 2024-04-05

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.

Conditions

Cardiovascular Diseases; Coronary Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

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

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

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Reed

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Reed, PhD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Heart Institute Research Corporation

Locations

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Countries

Canada

Other Identifiers

20200732-01H

Identifier Type: -

Identifier Source: org_study_id