Atrial FibrillationACUTE-AFNCT05085860
Acute Responses to Exercise in Females and Males With Symptomatic Atrial Fibrillation
A study testing Moderate-intensity continuous training (MICT) and High-intensity interval training (HIIT) in people with Atrial Fibrillation and Persistent Atrial Fibrillation, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Atrial Fibrillation, Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation
- What is being tested?
- Moderate-intensity continuous training (MICT) and High-intensity interval training (HIIT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 8 Feb 2022to 21 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Examining Acute Responses to Exercise in Symptomatic Females and Males With Atrial Fibrillation: a Pilot Randomized Crossover Study
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.
- Being tested
- Moderate-intensity continuous training (MICT), High-intensity interval training (HIIT)
- Keywords
- Exercise, Sex differences, Pilot, Symptoms
- Medical subject headings
- Atrial Fibrillation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate-intensity continuous training (MICT)Behavioural
Participants will engage in exercise and record AF symptoms prospectively over 7 days
High-intensity interval training (HIIT)Behavioural
Participants will engage in exercise and record AF symptoms prospectively over 7 days
| Study group | Role | What they receive |
|---|---|---|
| Moderate Intensity Continuous Training (MICT) | Experimental | Participants will do 3 sessions of moderate-intensity continous exercise training over 7 days Receives: Behavioral: Moderate-intensity continuous training (MICT) |
| High Intensity Interval Training (HIIT) | Experimental | Participants will do 3 sessions of high-intensity interval training over 7 days Receives: Behavioral: High-intensity interval training (HIIT) |
| Rest | No intervention | Participants will abstain from doing moderate- to high-intensity interval training over 7 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the pilot study - Recruitment and consent rate
Measured: Through study completion, an average of 1.5 years
Feasibility of the pilot study - Participant fidelity
E.g. ability of participants to comply with the exercise prescription, number of exercise sessions attended
Measured: During the week of HIIT and MICT (2 weeks)
Feasibility of the pilot study - Study retention
Dropout rate of participants
Measured: Through study completion, an average of 1.5 years
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?)
Measured: Through study completion, an average of 1.5 years
Feasibility of the pilot study - Adverse events
Side effects and adverse events during the study
Measured: Through study completion, an average of 1.5 years
Secondary outcomes (2)
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.
Measured: 3 weeks (1 week of HIIT, 1 week of MICT, 1 week fo rest)
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.
Measured: 3 weeks (1 week of HIIT, 1 week of MICT, 1 week fo rest)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start8 Feb 2022
- Primary completion21 Jul 2024
- Study completion21 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Reed, PhD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05085860
- Sponsor's protocol ID
- 20210524-01H
- Acronym
- ACUTE-AF
- Status last verified
- Jun 2026
- First submitted
- 13 Sep 2021
- Last updated
- 25 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Examining Acute Responses to Exercise in Symptomatic Females and Males With Atrial Fibrillation: a Pilot Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT05085860
- Acronym / sponsor ID
- ACUTE-AF / 20210524-01H
- Keywords
- Exercise, Sex differences, Pilot, Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 21 Jul 2024 (actual)
- Study completion
- 21 Jul 2024 (actual)
- First posted
- 20 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Moderate Intensity Continuous Training (MICT) | Experimental | Behavioral: Moderate-intensity continuous training (MICT)Participants will do 3 sessions of moderate-intensity continous exercise training over 7 days |
| High Intensity Interval Training (HIIT) | Experimental | Behavioral: High-intensity interval training (HIIT)Participants will do 3 sessions of high-intensity interval training over 7 days |
| Rest | No intervention | –Participants will abstain from doing moderate- to high-intensity interval training over 7 days |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate-intensity continuous training (MICT)Participants will engage in exercise and record AF symptoms prospectively over 7 days | Behavioural | Moderate Intensity Continuous Training (MICT) |
| High-intensity interval training (HIIT)Participants will engage in exercise and record AF symptoms prospectively over 7 days | Behavioural | High Intensity Interval Training (HIIT) |
Primary outcome
Feasibility of the pilot study - Recruitment and consent rate
Time frame: Through study completion, an average of 1.5 years
Feasibility of the pilot study - Participant fidelity
Time frame: During the week of HIIT and MICT (2 weeks)
E.g. ability of participants to comply with the exercise prescription, number of exercise sessions attended
Feasibility of the pilot study - Study retention
Time frame: Through study completion, an average of 1.5 years
Dropout rate of participants
Feasibility of the pilot study - Study eligibility refinement
Time frame: Through study completion, an average of 1.5 years
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?)
Feasibility of the pilot study - Adverse events
Time frame: Through study completion, an average of 1.5 years
Side effects and adverse events during the study
2 secondary outcomes
AF symptoms self-reported with a 7-day patient symptom questionnaire
Time frame: 3 weeks (1 week of HIIT, 1 week of MICT, 1 week fo rest)
AF status measured daily with a KardiaMobile device
Time frame: 3 weeks (1 week of HIIT, 1 week of MICT, 1 week fo rest)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Reed, PhD principal investigator
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate-intensity continuous training (MICT) and High-intensity interval training (HIIT) in people with Atrial Fibrillation and Persistent Atrial Fibrillation, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the pilot study - Recruitment and consent rate (time frame: Through study completion, an average of 1.5 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.