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

NCT05085860 | Recruiting

• 1 other identifier: 20210524-01H
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Atrial Fibrillation; Persistent Atrial Fibrillation; Paroxysmal Atrial Fibrillation

Keywords

Exercise; Sex differences; Pilot; Symptoms

Outcome Measures

Primary Outcomes (5)

• Feasibility of the pilot study - Recruitment and consent rate

  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

  During the week of HIIT and MICT (2 weeks)

• Feasibility of the pilot study - Study retention

  Dropout rate of participants

  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?)

  Through study completion, an average of 1.5 years

• Feasibility of the pilot study - Adverse events

  Side effects and adverse events during the study

  Through study completion, an average of 1.5 years

Secondary Outcomes (2)

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

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

• AF status measured daily with a KardiaMobile device

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

Study Arms (3)

Moderate Intensity Continuous Training (MICT)

EXPERIMENTAL

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

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

Behavioral: High-intensity interval training (HIIT)

Rest

NO INTERVENTION

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

Interventions

Moderate-intensity continuous training (MICT) BEHAVIORAL

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

Moderate Intensity Continuous Training (MICT)

High-intensity interval training (HIIT) BEHAVIORAL

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

High Intensity Interval Training (HIIT)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jennifer Reed, PhD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matheus Mistura

CONTACT

613-696-7000; mmistura@ottawaheart.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: October 20, 2021
• Study Start: February 8, 2022
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

CA (1)