Examining exercise effects on atrial fibrillation symptoms in men and women
Feasibility of Examining Acute Responses to Exercise in Symptomatic Females and Males With Atrial Fibrillation: a Pilot Randomized Crossover Study
This study is testing whether different types of exercise can help improve symptoms of atrial fibrillation in men and women.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Ottawa Heart Institute Research Corporation Academic / other |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT05085860 on ClinicalTrials.gov |
What this trial studies
This pilot project aims to assess the feasibility of a randomized crossover study that investigates short-term changes in symptoms of atrial fibrillation (AF) in symptomatic males and females with paroxysmal or persistent AF. Participants will engage in a week of moderate-intensity continuous training (MICT) or high-intensity interval training (HIIT) followed by a control week with no vigorous exercise. The study will also explore sex differences in symptom changes and AF status using self-reported questionnaires and device measurements. The goal is to understand how exercise impacts AF symptoms and to address patient concerns regarding exercise participation.
Who should consider this trial
Good fit: Ideal candidates include symptomatic males and females aged 40 and older with paroxysmal or persistent atrial fibrillation who are rate controlled and post-menopausal if female.
Not a fit: Patients currently engaged in routine exercise training or those with unstable medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help patients with atrial fibrillation better manage their symptoms through tailored exercise programs.
How similar studies have performed: While exercise has been shown to improve outcomes in patients with atrial fibrillation, this specific approach examining acute responses in a sex-specific manner is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Paroxysmal and Persistent AF * Rate controlled (resting ventricular rate \<110 bpm) * Able to do a symptom limited exercise test * At least 40 years of age * Self-reports being symptomatic in the past 4 weeks * If female, self-reports being post-menopausal * Able to read and understand English or French * Agrees to sign informed consent Exclusion Criteria: * Currently participating in routine exercise training * Unstable angina or uncontrolled diabetes mellitus; or established diagnosis of severe mitral or aortic stenosis, or hypertrophic obstructive cardiomyopathy with significant obstruction * Unable to access the Internet or a phone (iPhone and iPad require iOS version 10.0 and up, Android requires version 6.0 and up) during the study period * Has an automated external defibrillator, an implantable cardioverter defibrillator or other types of pacemaker * Unwilling or unable to complete the three conditions * Unable to provide written, informed consent
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: Matheus Mistura
- Email: mmistura@ottawaheart.ca
- Phone: 613-696-7000
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.