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Exercise Training in Women With Cardiac Devices

NCT ID: NCT05946304

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-28

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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

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

Group Type EXPERIMENTAL

moderate-intensity continuous exercise training (MICT) group

Intervention Type BEHAVIORAL

Exercise session: Warm-up: 60-70% peak heart rate (HR) - 10min; Training: 70-85% peak HR - 35min; Cool-down: 60-70% peak HR - 15min.

Standard care + high-intensity interval training (HIIT)

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

Group Type EXPERIMENTAL

high-intensity interval training (HIIT) group

Intervention Type BEHAVIORAL

Warm-up: 60-70% peak heart rate (HR) - 10min; Training: 85-95% peak HR - 25 minutes (4x4-minutes of high-intensity intervals interspersed with 3 minutes of low-intensity intervals); Cool-down: 60-70% peak HR - 10min.

Interventions

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moderate-intensity continuous exercise training (MICT) group

Exercise session: Warm-up: 60-70% peak heart rate (HR) - 10min; Training: 70-85% peak HR - 35min; Cool-down: 60-70% peak HR - 15min.

Intervention Type BEHAVIORAL

high-intensity interval training (HIIT) group

Warm-up: 60-70% peak heart rate (HR) - 10min; Training: 85-95% peak HR - 25 minutes (4x4-minutes of high-intensity intervals interspersed with 3 minutes of low-intensity intervals); Cool-down: 60-70% peak HR - 10min.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer Reed, PhD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Heart Institute Research Corporation

Locations

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University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Jennifer Reed, PhD

Role: CONTACT

Phone: 613-696-7392

Email: [email protected]

Isabela Marcal, MSc

Role: CONTACT

Phone: 6136967000

Email: [email protected]

Facility Contacts

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Jennifer Reed, PhD

Role: primary

Matheus Mistura, MSc

Role: backup

Other Identifiers

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20230095-01H

Identifier Type: -

Identifier Source: org_study_id