Exercise Training in Patients With Persistent or Permanent Atrial Fibrillation

NCT03397602 | Recruiting DMC

• 1 other identifier: 0906
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; exercise

Outcome Measures

Primary Outcomes (2)

• 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.

  baseline to 12 weeks

• 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.

  baseline to 12 weeks

Secondary Outcomes (11)

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

  baseline to 12 weeks

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

  baseline to 12 weeks

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

  baseline to 12 weeks

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

  baseline to 12 weeks

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

  baseline to 12 weeks

Study Arms (3)

standard care

NO INTERVENTION

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

standard care + MICE

EXPERIMENTAL

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

Behavioral: standard care + moderate-intensity continuous exercise training

standard care + HIIT

EXPERIMENTAL

standard care + high-intensity interval training (HIIT)

Behavioral: standard care + high-intensity interval training

Interventions

standard care + moderate-intensity continuous exercise training BEHAVIORAL

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

standard care + MICE

standard care + high-intensity interval training BEHAVIORAL

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

standard care + HIIT

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• currently participating in routine exercise training (more than two times per week);
• unstable angina;
• diagnosed severe mitral or aortic stenosis;
• diagnosed hypertrophic obstructive cardiomyopathy with significant obstruction;
• pregnant, lactating or planning to become pregnant during the study period;
• unable to provide written, informed consent, or
• unwilling or unable to return for follow up at week 12.

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (2)

London Health Sciences Network

London, Ontario, Canada

RECRUITING

University of Ottawa Heart Insititue

Ottawa, Ontario, K1Y 4W7, Canada

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Motor Activity

Interventions

Standard of Care; High-Intensity Interval Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jennifer L Reed, PhD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer L Reed, PhD

CONTACT

613-696-7392; jreed@ottawaheart.ca

Matheus Mistura, MSc

CONTACT

613-696-7000; mmistura@ottawaheart.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2018
• First Posted: January 12, 2018
• Study Start: January 23, 2019
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2037
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

CA (2)