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Exercise Training in Women With Cardiac Devices | Clinical Trials | Clareo Health

COMPLETEDNA

Exercise Training in Women With Cardiac Devices

The Effects of Exercise Training on Physical and Mental Health in Women With Cardiac Implantable Electronic Devices (CIED-EX): a Pilot Study

NCT05946304•Ottawa Heart Institute Research Corporation

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

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).

Locations (1)

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Key Dates

Start Date

November 28, 2023

Primary Completion Date

August 18, 2025

Completion Date

August 18, 2025

Last Updated

March 13, 2026

Enrollment

ACTUAL participants

Conditions

Cardiovascular Diseases

Interventions

moderate-intensity continuous exercise training (MICT) group

BEHAVIORAL

high-intensity interval training (HIIT) group

BEHAVIORAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Exercise Training in Women With Cardiac Devices

Inclusion Criteria

Exclusion Criteria

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