ClinicalTrials.gg
RecruitingNCT03397602Exercise-AFUpdated Mar 11, 2026

Exercise Training in Patients With Persistent or Permanent Atrial Fibrillation

An interventional study of standard care + moderate-intensity continuous exercise training and standard care + high-intensity interval training in Atrial Fibrillation, sponsored by Ottawa Heart Institute Research Corporation. Recruiting at 2 sites in Canada. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-03-11.

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

From the registry’s dates

  • Started Jan 2019; still recruiting 7 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
132
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 24 studies in Atrial Fibrillation by Ottawa Heart Institute Research Corporation — 7 open to participants now, 11 under way, none of them phase 3. Atrial Fibrillation · Ottawa Heart Institute Research Corporation.

Planned enrollment
10th of 21
132 · median 102
Started
2019
the only one that year
No phase
18 of 24
6 open now
Primary completion
2027-12
later than 5 of 10 live
Registered
15th of 24
by date

Among the 24 studies in Atrial Fibrillation by Ottawa Heart Institute Research Corporation, this one is the 10th largest by planned enrollment of the 21 interventional ones that give a count, is the only one that started in 2019, is one of 18 with no phase, reaches primary completion later than 5 of the 10 other live ones, and was the 15th registered.

Atrial Fibrillation

4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.

Browse Atrial Fibrillation studies →

Open to participants now

7 of the 24 studies in Atrial Fibrillation by Ottawa Heart Institute Research Corporation are open now, in 2 countries. Recruiting first, the newest first:

1 more — sign in →

By country, each count listing its studies:

All 7 open studies →

Who these studies take

Of the 612 Atrial Fibrillation studies recruiting now, 407 (67%) set no upper age limit and 44 (7%) stop at 75 or younger; 21 take children under 18; 43 take healthy volunteers.

This study: 40 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 24 studies in Atrial Fibrillation by Ottawa Heart Institute Research Corporation, or all of them as a file.
02

Study summary

The main purpose of this project is to evaluate the effects of high-intensity interval training (HIIT) compared to moderate-intensity continuous exercise training (MICE) and standard care on exercise capacity and quality of life in patients with persistent or permanent atrial fibrillation. Positive findings are vitally important for these patients, given the condition's substantial morbidity, mortality and high economic costs.

Read the detailed description

Recommended standards of care do not include the prescription of exercise to target and ameliorate the progressive health decline and overall feeling of well-being in patients with atrial fibrillation. Recent Standards for the Provision of Cardiac Rehabilitation of Ontario are calling for the consideration for referral and enrollment of patients with atrial fibrillation in cardiovascular rehabilitation - evidence is needed to support and confirm these efforts. The main purpose of this project is to evaluate the effects of high-intensity interval training (HIIT) compared to moderate-intensity continuous exercise training (MICE) and standard care on exercise capacity and quality of life in patients with persistent or permanent atrial fibrillation. Positive results from this study will identify a new intervention that: produces important improvements in patient-rated clinical, behavioural and exercise outcomes; provides mechanistic insight into the role of exercise training in the management of atrial fibrillation; requires minimal equipment; and, is appealing to patients with atrial fibrillation.

03

Conditions studied

  • Atrial Fibrillation

Keywords

  • atrial fibrillation
  • exercise
04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. persistent or permanent atrial fibrillation;
  2. rate controlled with a resting ventricular rate of equal to or less than 100 bpm;
  3. able to perform a symptom-limited exercise test;
  4. at least 40 years of age (i.e. participants must be 40 years or older);

Exclusion criteria

Exclusion Criteria:

  1. currently participating in routine exercise training (more than two times per week);
  2. unstable angina;
  3. diagnosed severe mitral or aortic stenosis;
  4. diagnosed hypertrophic obstructive cardiomyopathy with significant obstruction;
  5. pregnant, lactating or planning to become pregnant during the study period;
  6. unable to provide written, , or
  7. unwilling or unable to return for follow up at week 12.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
132 participants (estimated)

Study arms

  • No intervention
    standard care

    Participants do not participate in a on site structured exercise training program.

  • Experimental
    standard care + MICE

    standard care + moderate-intensity continuous exercise training (MICE)

    Behavioral: standard care + moderate-intensity continuous exercise training

  • Experimental
    standard care + HIIT

    standard care + high-intensity interval training (HIIT)

    Behavioral: standard care + high-intensity interval training

Interventions

  • Behavioralstandard care + moderate-intensity continuous exercise training

    Participants will attend on-site moderate-intensity continuous exercise training two times weekly for 12 weeks.

  • Behavioralstandard care + high-intensity interval training

    Participants will attend on-site high-intensity interval training two times weekly for 12 weeks.

06

What researchers measure

Primary outcomes

  1. Changes in quality of life measured by the physical component summary (PCS) measure of the Short Form 36 Health Survey Questionnaire (SF-36).

    Changes in quality of life measured by the physical component summary (PCS) measure of the Short Form 36 Health Survey Questionnaire (SF-36) from baseline to 12 weeks.

    Time frame: baseline to 12 weeks

  2. Changes in exercise capacity measured by VO2peak on a symptom-limited cardiopulmonary exercise test (CPET).

    Changes in exercise capacity measured by VO2peak on a symptom-limited cardiopulmonary exercise test (CPET) from baseline to 12 weeks.

    Time frame: baseline to 12 weeks

Secondary outcomes

  1. Changes atrial fibrillation specific quality of life measured by the Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT).

    Changes atrial fibrillation specific quality of life measured by the Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT). The AFEQT assesses 4 domains: symptoms, activities, treatment concern, treatment satisfaction, and a summary score that includes the first 3 domains. Patients will assess the impact of AF on their health status during the previous 4 weeks. Responses are presented as a 7-point Likert scale. Raw scores within each domain are transformed to a 0 (most severe symptoms) to 100 scale (no limitations or disability). The AFEQT is valid, reliable and sensitive to clinical change in patients with AF undergoing different therapeutic interventions.

    Time frame: baseline to 12 weeks

  2. Changes atrial fibrillation specific quality of life measured by the University of Toronto Atrial Fibrillation Severity Scale (AFSS).

    Changes atrial fibrillation specific quality of life measured by the University of Toronto Atrial Fibrillation Severity Scale (AFSS) from baseline to 12 weeks. The AFSS is a disease-specific quality of life measure used to capture subjective and objective ratings of disease burden in patients with atrial fibrillation. It assesses atrial fibrillation burden (score 1-30; higher scores indicate higher burden); Global Well Being (a visual analogue scale ranging from 1-10, indicating a patient reports as having a worst possible life \[0\] to the best possible life\[10\]); AF symptom score (score of 0-35; higher scores indicate more bothered by AF symptoms); and health care utilization (score of 0-21; higher scores indicate greater health care utilization).

    Time frame: baseline to 12 weeks

  3. Changes in symptom burden measured by the Canadian Cardiovascular Society Severity of Atrial Fibrillation Scale.

    Changes in symptom burden measured by the Canadian Cardiovascular Society Severity of Atrial Fibrillation Scale from baseline to 12 weeks.The CCS-SAF is a simple, concise, symptom-based severity scale to assess patient status. CCS-SAF scores range from 0 to 4, with highest values denoting severe impact of symptoms on quality of life and activities of daily living. The CCS-SAF has been validated in patients with atrial fibrillation.

    Time frame: baseline to 12 weeks

  4. Changes in quality of life measured by the mental component summary (MCS) measure of the Short Form 36 Health Survey Questionnaire (SF-36).

    Changes in quality of life measured by the mental component summary (MCS) measure of the Short Form 36 Health Survey Questionnaire (SF-36) from baseline to 12 weeks. The SF-36 is a widely used and thoroughly validated, standardized, generic health survey with 36 questions. It yields an 8-scale (physical functioning; role-physical; bodily pain; general health; vitality; social functioning; role-emotional; and, mental health) profile of functional health and well-being scores as well as psychometrically-based physical (PCS) and mental (MCS) component summary scores.

    Time frame: baseline to 12 weeks

  5. Changes in heart rate control measured by 24-hour Holter ECG recordings and ECG recordings at each CPET.

    Changes in heart rate control measured by 24-hour Holter ECG recordings and ECG recordings at each CPET from baseline to 12 weeks.

    Time frame: baseline to 12 weeks

  6. Changes in lower body muscular fitness measured by standard load tests.

    Changes in lower body muscular fitness measured by standard load tests from baseline to 12 weeks.

    Time frame: baseline to 12 weeks

  7. Changes in volume and intensity of exercise measured directly by accelerometer.

    Changes in volume and intensity of exercise measured directly by accelerometer from baseline to 12 weeks.

    Time frame: baseline to 12 weeks

  8. Changes in volume and intensity of exercise measured by self-report (exercise logs).

    Changes in volume and intensity of exercise measured by self-report (exercise logs) from baseline to 12 weeks.

    Time frame: baseline to 12 weeks

  9. Changes in self-reported symptom frequency and severity measured by the 7-day symptom diary.

    Changes in self-reported symptom frequency and severity measured by the 7-day symptom diary from baseline to 12 weeks.

    Time frame: baseline to 12 weeks

  10. Changes in self reported sleep patterns measured by the 7-day sleep diary.

    Changes in self reported sleep patterns measured by the 7-day sleep diary from baseline to 12 weeks.

    Time frame: baseline to 12 weeks

  11. Changes in blood biomarker concentrations (participants at the University of Ottawa Heart Institute site only).

    Changes in blood biomarker concentrations from baseline to 12 weeks (participants at the University of Ottawa Heart Institute site only).

    Time frame: baseline to 12 weeks

07

Study locations

2 of 2 sites recruiting
  • London Health Sciences Network
    London, Ontario, Canada
    Recruiting
  • University of Ottawa Heart Insititue
    Ottawa, Ontario K1Y 4W7, Canada
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2019 (actual). Primary completion is estimated for Dec 2027, 107 months after the start.

Of 796 non-industry interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's planned 107 months is above that.

Counting every sponsor, half of 1,051 studies reached it within 33 months; a quarter within 18 and three quarters within 54.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 4, 2018
First posted
Jan 12, 2018
StartActual
Jan 23, 2019
Primary completionEst.
Dec 30, 2027
CompletionEst.
Dec 30, 2037
Last update
Mar 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03397602
Responsible party
Sponsor
First posted
Jan 12, 2018
Start date
Jan 23, 2019
Primary completion
Dec 30, 2027 (estimated)
Completion
Dec 30, 2037 (estimated)
Last update
Mar 11, 2026

Study contacts

Jennifer L Reed, PhD
Contact
jreed@ottawaheart.ca
613-696-7392
Matheus Mistura, MSc
Contact
mmistura@ottawaheart.ca
613-696-7000 ext. 15944
Jennifer L Reed, PhD
principal investigator · Ottawa Heart Institute Research Corporation

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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