Acute Responses to Exercise in Females and Males With Symptomatic Atrial Fibrillation (ACUTE-AF)

University of Ottawa Heart Institute

Status: Enrolling

Conditions: Paroxysmal Atrial Fibrillation; Atrial Fibrillation; Persistent Atrial Fibrillation

Treatments: Behavioral: High-intensity interval training (HIIT); Behavioral: Moderate-intensity continuous training (MICT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05085860

20210524-01H

Details and patient eligibility

About

The main purpose of this pilot project is to measure the feasibility of conducting a randomized crossover study examining short-term changes in atrial fibrillation (AF) symptoms in symptomatic females and males with paroxysmal or persistent AF when they engage in a standard week of exercise (i.e. moderate-intensity continuous training [MICT] or high-intensity interval training [HIIT]) compared to a control week (i.e. no moderate to vigorous exercise over 7 days).

Full description

Exercise training (e.g. 8 to 12-week exercise programs) has been shown to improve cardiorespiratory fitness and QoL, and reduce atrial fibrillation (AF) symptoms and time in AF in patients with AF. However, regular exercise participation is hindered by patient concerns regarding an increase in AF symptoms and episodes during or following an exercise session. Patients with AF also worry about potential negative consequences of increasing heart rate during exercise. This fear may be sex-specific as females report more AF symptoms at rest, experience faster heart rates during exercise and AF, and report greater symptoms of fear/anxiety than males. How exercise acutely changes AF symptoms remains to be examined.

The main purpose of this pilot project is to measure the feasibility of conducting a randomized crossover study examining short-term changes in AF symptoms in symptomatic females and males with paroxysmal or persistent AF when they engage in a standard week of exercise (i.e. moderate-intensity continuous training [MICT] or high-intensity interval training [HIIT]) compared to a control week (i.e. no moderate to vigorous exercise over 7 days). As secondary outcomes we will explore sex differences in short-term changes in AF symptoms (self reported with a questionnaire) and AF status (device measured with a wireless four-finger AliveCor KardiaMobile ECG) when symptomatic patients with AF engage in a standard week of exercise (i.e. HIIT, MICT) compared to a control week. Results from this pilot study will provide novel insight into the typical acute response to exercise in females and males with AF, and will inform appropriate approaches for the conduct of a future larger trial. This work is key to informing practitioners and patients of the typical acute exercise response in the AF population with the goal of facilitating exercise prescription and participation.

Enrollment: 36 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

Moderate Intensity Continuous Training (MICT)

Experimental group

Description:

Participants will do 3 sessions of moderate-intensity continous exercise training over 7 days

Treatment:

Behavioral: Moderate-intensity continuous training (MICT)

High Intensity Interval Training (HIIT)

Experimental group

Description:

Participants will do 3 sessions of high-intensity interval training over 7 days

Treatment:

Behavioral: High-intensity interval training (HIIT)

Rest

No Intervention group

Description:

Participants will abstain from doing moderate- to high-intensity interval training over 7 days