Exercise programs for women with heart devices
The Effects of Exercise Training on Physical and Mental Health in Women With Cardiac Implantable Electronic Devices (CIED-EX): a Pilot Study
This study is testing whether a 12-week virtual exercise program using either high-intensity or moderate-intensity workouts can help women with heart devices improve their fitness and overall well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Ottawa Heart Institute Research Corporation Academic / other |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT05946304 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the feasibility and effects of a 12-week virtual exercise program comparing high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) specifically for women with cardiac implantable electronic devices (CIED). The study aims to assess improvements in physical fitness, quality of life, and mental health outcomes. It employs a mixed-methods approach, combining quantitative measures with qualitative insights to understand participants' experiences and barriers to exercise. The goal is to determine which exercise modality is more beneficial for this population.
Who should consider this trial
Good fit: Ideal candidates are women with cardiac implantable electronic devices who have been stable for at least six months and are able to engage in exercise.
Not a fit: Patients currently engaged in regular exercise training or those with significant medical or psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the fitness and quality of life for women with cardiac devices.
How similar studies have performed: Other studies have shown positive outcomes with high-intensity interval training in similar populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Ottawa, Ontario
- University of Ottawa Heart Institute — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Jennifer Reed, PhD — Ottawa Heart Institute Research Corporation
- Study coordinator: Jennifer Reed, PhD
- Email: jreed@ottawaheart.ca
- Phone: 613-696-7392
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.