Exercise Training in Women With Cardiac Devices (NCT05946304) | Clinical Trial Compass
CompletedNot Applicable
Exercise Training in Women With Cardiac Devices
Canada20 participantsStarted 2023-11-28
Plain-language summary
Cardiac implantable electronic devices (CIED) are established treatments for a variety of cardiac arrhythmias. Women with CIED have lower fitness and lower quality of life compared to men with CIED. Moderate-intensity continuous training (MICT) is the most prescribed exercise for women. However, high-intensity interval training (HIIT) has been shown to improve fitness, anxiety levels, quality of life, and other health indicators over MICT in men with CIED. There is a need to quantitatively evaluate the feasibility and effects of a virtual HIIT vs. virtual MICT program on the physical, quality of life, and mental health of women with CIED. Furthermore, a qualitative approach is also necessary to understand patients' experiences, barriers, and facilitators of a virtual exercise intervention. This mixed-methods pilot randomized controlled trial will assess the feasibility of a 12-week virtual HIIT and MICT program in women with CIED.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Women (i.e., female sex assigned at birth) with CIED (≥6 months since implant)
✓. Women with CIED in optimal medical therapy and functioning;
✓. Patient is able to perform a symptom-limited CPET;
✓. Patient is able to read and understand English or French.
Exclusion criteria
✕. Patient is currently participating in routine exercise training (\>2x/week);
✕. Patient has: documented unstable angina; or established diagnosis of chronic obstructive pulmonary disease, severe mitral or aortic stenosis, or hypertrophic obstructive cardiomyopathy;
✕. Patient has an unmanaged psychiatric illness (e.g., active psychosis, suicidal ideation) or cognitive impairment;
✕. Patient does not have an internet connection or a device with a camera and speakers;
✕. Patient with any device troubleshooting at resting or during exercise;
What they're measuring
1
Feasibility - Number of classes participants attended
Timeframe: Week 12
2
Feasibility - Compliance to the exercise prescription based on heart rate
Timeframe: Week 12
3
Feasibility - Adverse events
Timeframe: Week 12
4
Feasibility - Number of dropouts
Timeframe: Week 12
Trial details
NCT IDNCT05946304
SponsorOttawa Heart Institute Research Corporation