NCT06494163 Exercise Training in Women With Heart Disease 2
| NCT ID | NCT06494163 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ottawa Heart Institute Research Corporation |
| Condition | Cardiovascular Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 172 participants |
| Start Date | 2025-01-27 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 172 participants in total. It began in 2025-01-27 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 1. 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); 2. 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 3. Patient is able to read and understand English or French. Exclusion Criteria: 1. 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); 2. 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); 3. Patient has uncontrolled arrhythmia (this may impact the HR-based exercise training prescription and monitoring); 4. Patient is unable to provide written informed consent; or 5. Patient is unwilling or unable to return for follow-up visits at 12 and 26 weeks. 6. Patient is unwilling to be randomized to HIIT or MICT.
Contact & Investigator
Jennifer Reed, PhD
PRINCIPAL INVESTIGATOR
Ottawa Heart Institute Research Corporation
Frequently Asked Questions
Who can join the NCT06494163 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Cardiovascular Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06494163 currently recruiting?
Yes, NCT06494163 is actively recruiting participants. Contact the research team at jreed@ottawaheart.ca for enrollment information.
Where is the NCT06494163 trial being conducted?
This trial is being conducted at Ottawa, Canada.
Who is sponsoring the NCT06494163 clinical trial?
NCT06494163 is sponsored by Ottawa Heart Institute Research Corporation. The principal investigator is Jennifer Reed, PhD at Ottawa Heart Institute Research Corporation. The trial plans to enroll 172 participants.