Exercise Training in Women With Cardiac Devices (CIED-EX)

University of Ottawa Heart Institute

Status: Enrolling

Conditions: Cardiovascular Diseases

Treatments: Behavioral: high-intensity interval training (HIIT) group; Behavioral: moderate-intensity continuous exercise training (MICT) group

Study type: Interventional

Funder types: Other

Identifiers

NCT05946304

20230095-01H

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Women (i.e., female sex assigned at birth) with CIED (≥6 months since implant)
2. Women with CIED in optimal medical therapy and functioning;
3. Patient is able to perform a symptom-limited CPET;
4. Patient is able to read and understand English or French.

Exclusion criteria

1. Patient is currently participating in routine exercise training (>2x/week);
2. Patient has: documented unstable angina; or established diagnosis of chronic obstructive pulmonary disease, severe mitral or aortic stenosis, or hypertrophic obstructive cardiomyopathy;
3. Patient has an unmanaged psychiatric illness (e.g., active psychosis, suicidal ideation) or cognitive impairment;
4. Patient does not have an internet connection or a device with a camera and speakers;
5. Patient with any device troubleshooting at resting or during exercise;
6. Patient is unable to provide written informed consent;
7. Patient is unwilling or unable to return for follow-up visits at week 12;
8. Patient is unwilling to be randomized to HIIT or MICT; or
9. Pregnancy or patients who become pregnant during the 12-week intervention phase (the effects of interval training on an unborn fetus are unknown).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Standard care + moderate-intensity continuous exercise training (MICT)

Experimental group

Description:

Supervised virtual MICT exercise sessions for 12 weeks (2x/wk) using the platform Zoom Care.

Treatment:

Behavioral: moderate-intensity continuous exercise training (MICT) group

Standard care + high-intensity interval training (HIIT)

Experimental group

Description:

Supervised virtual HIIT exercise sessions for 12 weeks (2x/wk) using the platform Zoom Care.

Treatment:

Behavioral: high-intensity interval training (HIIT) group