Exercise Training in Women With Heart Disease 2

ConditionsCardiovascular Diseases Coronary Heart Disease

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18+

SponsorOttawa Heart Institute Research Corporation

About this trial

This study will compare the effects of two different types of training on exercise capacity in women with coronary heart disease (CHD). Participants will be randomized into either the virtual high-intensity interval training (HIIT) or the virtual moderate-to-vigorous intensity continuous training (MICT). After randomization, patients will exercise twice a week, for 12 weeks. The sessions will be conducted virtually. Patients will undergo a maximal exercise test, cardiometabolic indicators (height (cm), body mass (kg), body composition (%), waist circumference (cm) and, resting blood pressure) and complete questionnaires about quality of life, mental health, self-determined motivation, self-efficacy and enjoyment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women (i.e., female sex assigned at birth) with CHD (e.g., coronary artery bypass grafting surgery [CABG], percutaneous coronary intervention [PCI], acute myocardial infarction [MI], MI with no obstructive coronary artery disease [MINOCA], or ischemia with no obstructive coronary artery disease [INOCA] at least 4 weeks post procedure or event; based on clinical evidence this is a safe period of time to exercise);

Patient is able to perform a symptom limited CPET (this is the primary outcome and needed to determine peak HR for the exercise training prescription); and

Patient is able to read and understand English or French.

Disqualifiers

Patient is currently participating in routine exercise training (>2x/week, routine exercise training is defined as a planned, structured, and repetitive exercise that is performed in order to maintain or improve physical fitness.) (this may reduce the impact of HIIT or MICT on outcomes);

Patient has: NYHA class III-IV heart failure symptoms; 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 MICT or HIIT);

Patient has uncontrolled arrhythmia (this may impact the HR-based exercise training prescription and monitoring);

Patient is unable to provide written informed consent; or

Trial design

Design model

Parallel

Treatments tested in this trial

Exercise
Behavioral
The MICT and HIIT intervention groups will complete supervised virtual exercise sessions for 12 weeks using Zoom care or Microsoft Teams as a backup resource. The appointments will be scheduled and conducted 2 days per week. Initially, exercise intensity will be determined from participants' peak HR achieved during a baseline CPET.

Treatment groups

172 Participants

are divided into 2 treatment groups

Group A: standard care + moderate-intensity continuous exercise trainingExperimental treatment 1 intervention

Group B: standard care + high-intensity interval trainingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Exercise capacity

will be measured using a gold standard symptom-limited, cardiopulmonary exercise test (CPET) on a treadmill (or on an alternate equipment, such as a cycle ergometer or recumbent bike). Gas exchange will be monitored continuously (- Parvo Medics TrueOne® 2400); the highest 20 second average rate of oxygen uptake achieved (i.e. peak VO2 in mL/kg/min) during the last minute of the CPET will represent exercise capacity.

Time frame

from baseline to week-6 and from baseline to week-12

Secondary outcomes

physical and mental health

hysical 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.

Time frame