RecruitingNot ApplicableNCT06494163

Exercise Training in Women With Heart Disease 2

Exercise Training in Women With Heart Disease: A Randomized Controlled Trial


Sponsor

Ottawa Heart Institute Research Corporation

Enrollment

172 participants

Start Date

Jan 27, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria3

  • 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.

Exclusion Criteria6

  • 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
  • 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 MICT.

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Interventions

BEHAVIORALExercise

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.


Locations(1)

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

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NCT06494163


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