CClinicalTrials.gg
CompletedNCT05085860ACUTE-AFUpdated Jun 25, 2026

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

An interventional study of Moderate-intensity continuous training (MICT) and High-intensity interval training (HIIT) in Atrial Fibrillation, Persistent Atrial Fibrillation and Paroxysmal Atrial Fibrillation, sponsored by Ottawa Heart Institute Research Corporation. Completed at 1 site in Canada. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-06-25.

Sponsored by Ottawa Heart Institute Research Corporation · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study summary

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).

Read the detailed 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.

02

Conditions studied

  • Atrial Fibrillation
  • Persistent Atrial Fibrillation
  • Paroxysmal Atrial Fibrillation

Keywords

  • Exercise
  • Sex differences
  • Pilot
  • Symptoms
03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 25 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Ottawa Heart Institute Research Corporation is the lead sponsor of 179 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Moderate Intensity Continuous Training (MICT)

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

    Behavioral: Moderate-intensity continuous training (MICT)

  • Experimental
    High Intensity Interval Training (HIIT)

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

    Behavioral: High-intensity interval training (HIIT)

  • No intervention
    Rest

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

Interventions

  • BehavioralModerate-intensity continuous training (MICT)

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

  • BehavioralHigh-intensity interval training (HIIT)

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

06

What researchers measure

Primary outcomes

  1. Feasibility of the pilot study - Recruitment and consent rate

    Time frame: Through study completion, an average of 1.5 years

  2. Feasibility of the pilot study - Participant fidelity

    E.g. ability of participants to comply with the exercise prescription, number of exercise sessions attended

    Time frame: During the week of HIIT and MICT (2 weeks)

  3. Feasibility of the pilot study - Study retention

    Dropout rate of participants

    Time frame: Through study completion, an average of 1.5 years

  4. Feasibility of the pilot study - Study eligibility refinement

    Data to refine inclusion and exclusion criteria for a larger trial will be used by balancing safety, ability to complete the intervention, and generalizability (e.g. is an exclusion criterion of threshold of participation in \>2 structured exercise sessions/week sufficient or restrictive?)

    Time frame: Through study completion, an average of 1.5 years

  5. Feasibility of the pilot study - Adverse events

    Side effects and adverse events during the study

    Time frame: Through study completion, an average of 1.5 years

Secondary outcomes

  1. AF symptoms self-reported with a 7-day patient symptom questionnaire

    Secondary objectives will explore sex differences in short-term changes in AF symptoms when symptomatic females and males with AF engage in a standard week of exercise (MICT or HIIT), compared to a control (rest) week. Participants will report AF symptoms prospectively during each condition. They will complete a 7-day questionnaire during MICT, a 7-day questionnaire during HIIT and a 7-day questionnaire during the rest week.

    Time frame: 3 weeks (1 week of HIIT, 1 week of MICT, 1 week fo rest)

  2. AF status measured daily with a KardiaMobile device

    Secondary objectives will explore sex differences in short-term changes in AF status when symptomatic females and males with AF engage in a standard week of exercise (MICT or HIIT), compared to a control week. AF status will be measured with a Kardiamobile AliveCor wireless device. Participants will be asked to record 3 x 30-second ECGs a day (morning, afternoon, evening) during each condition (MICT, HIIT and rest). The ECG recording will allow the identification of whether the participant is in sinus rhythm or in atrial fibrillation.

    Time frame: 3 weeks (1 week of HIIT, 1 week of MICT, 1 week fo rest)

07

Study locations

1 site
  • University of Ottawa Heart Institute
    Ottawa, Ontario K1Y4W7, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05085860
Lead sponsor
Ottawa Heart Institute Research Corporation
Responsible party
Sponsor
First posted
Oct 20, 2021
Start date
Feb 8, 2022
Primary completion
Jul 21, 2024
Completion
Jul 21, 2024
Last update
Jun 25, 2026

Study contacts

Jennifer Reed, PhD
principal investigator · Ottawa Heart Institute Research Corporation

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion