NCT05946304

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Ottawa Heart Institute Research Corporation · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
BEHAVIORAL	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.
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.

Timeline

• Start date: 2023-11-28
• Primary completion: 2025-08-18
• Completion: 2025-08-18
• First posted: 2023-07-14
• Last updated: 2026-03-13

Locations

1 site across 1 country: Canada