Exercise Training in Women With Heart Disease

NCT04781504 | Completed

• 1 other identifier: 20200732-01H
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• physical and mental health

  from baseline to 12 weeks and baseline to 26 weeks

• Disease-specific Quality of Life, global health, physical and emotional health

  from baseline to 12 weeks and baseline to 26 weeks

• Anxiety

  from baseline to 12 weeks and baseline to 26 weeks

• Depression

  from baseline to 12 weeks and baseline to 26 weeks

• body composition - BMI

  from baseline to 12 weeks and baseline to 26 weeks

Other Outcomes (1)

• Physical activity levels

  from baseline to 12 weeks and baseline to 26 weeks

Study Arms (2)

standard care + moderate-intensity continuous exercise training

EXPERIMENTAL

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

standard care + high-intensity interval training

EXPERIMENTAL

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

Interventions

Exercise 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; standard care + moderate-intensity continuous exercise training

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Coronary Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jennifer Reed, PhD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 30, 2020
• First Posted: March 4, 2021
• Study Start: April 5, 2021
• Primary Completion: January 4, 2024
• Study Completion: April 5, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05

Locations

CA (1)