Acute Responses to Exercise in Females and Males With Symptomatic Atrial Fibrillation

NCT ID: NCT05085860

Last Updated: 2025-11-20

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-08

Study Completion Date

2026-04-01

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Atrial Fibrillation Persistent Atrial Fibrillation Paroxysmal Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This is a repeated measures randomized counter-balanced design. All participants will complete three conditions in a randomized order, with a wash-out week in between.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Moderate Intensity Continuous Training (MICT)

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

Group Type EXPERIMENTAL

Moderate-intensity continuous training (MICT)

Intervention Type BEHAVIORAL

Participants will engage in exercise and record AF symptoms prospectively over 7 days

High Intensity Interval Training (HIIT)

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

Group Type EXPERIMENTAL

High-intensity interval training (HIIT)

Intervention Type BEHAVIORAL

Participants will engage in exercise and record AF symptoms prospectively over 7 days

Rest

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Moderate-intensity continuous training (MICT)

Participants will engage in exercise and record AF symptoms prospectively over 7 days

Intervention Type BEHAVIORAL

High-intensity interval training (HIIT)

Participants will engage in exercise and record AF symptoms prospectively over 7 days

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

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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Matheus Mistura

Role: CONTACT

613-696-7000 ext. 15944

Facility Contacts

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Jennifer L Reed, PhD

Role: primary

6136967392 ext. 67392

Matheus Mistura, MSc, BSc

Role: backup

6136967000 ext. 15944

Other Identifiers

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20210524-01H

Identifier Type: -

Identifier Source: org_study_id

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