Exercise Training in Patients With Atrial Fibrillation (OPPORTUNITY Study)

NCT02602457 | Active Not Recruiting

• 1 other identifier: 20150427
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

Atrial fibrillation is the most common heart rhythm disorder. The management of atrial fibrillation is of great importance. Despite the presence of exercise intolerance, weight gain, and an associated decline in overall health and well-being in patients living with atrial fibrillation, recommended standard care does not currently include the prescription of exercise to address these significant health issues. Exercise training is a recognized form of treatment of persons with heart disease. An exercise program such as high-intensity interval training when compared to moderate-intensity continuous exercise training may provide a stronger training stimulus for exercise and clinical outcomes; may be more efficient and motivating; and, may help to improve adherence to exercise training in persistent or permanent atrial fibrillation patients. This has been shown in patients with coronary artery disease and heart failure. The primary objectives of this prospective study are to examine the impact of high-intensity interval training compared to moderate-intensity continuous exercise training in adults with persistent or permanent atrial fibrillation on exercise capacity and quality of life.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Change in quality of life as measured by the Short-Form 36 questionnaire

  Change in quality of life from baseline to 12 weeks as measured by the Short Form-36 questionnaire.

  baseline to 12 weeks

• Change in exercise capacity as measured by six-minute walk test distance

  Change in exercise capacity from baseline to 12 weeks as measured by six-minute walk test distance.

  baseline to 12 weeks

Secondary Outcomes (12)

• Change in exercise adherence measured by accelerometer

  baseline to 12 weeks

• Change in activity status measured by the Duke Activity Status Index

  baseline to 12 weeks

• Change in symptom burden measured by the Canadian Cardiovascular Society Severity of Atrial Fibrillation scale

  baseline to 12 weeks

• Change in symptom frequency and severity measured using the 7-day symptom diary

  baseline to 12 weeks

• Change in disease specific quality of life will be measured using the University of Toronto Atrial Fibrillation Severity Scale (AFSS)

  baseline to 12 weeks

Study Arms (2)

Moderate-intensity continuous exercise

EXPERIMENTAL

Moderate-intensity continuous exercise training

Behavioral: moderate-intensity continuous exercise training

High-Intensity Interval Training

EXPERIMENTAL

High-Intensity Interval Training

Behavioral: high-intensity interval training

Interventions

moderate-intensity continuous exercise training BEHAVIORAL

Participants will complete supervised exercise sessions. Moderate-intensity continuous exercise training will follow cardiovascular rehabilitation guidelines. Participants will attend on-site moderate-intensity continuous exercise training two times weekly for 12 weeks.

Moderate-intensity continuous exercise

high-intensity interval training BEHAVIORAL

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

High-Intensity Interval Training

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 110 bpm;
• able to perform a symptom-limited exercise test;
• at least 40 years of age;
• patient agrees to sign informed consent.

You may not qualify if:

• currently participating in routine exercise training (more than two times per week);
• unstable angina;
• uncontrolled diabetes mellitus;
• diagnosed severe mitral or aortic stenosis;
• diagnosed hypertrophic obstructive cardiomyopathy with significant obstruction;
• unable to provide written, informed consent.

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Insititue

Ottawa, Ontario, K1Y 4W7, Canada

Location

Related Publications (1)

• Reed JL, Terada T, Vidal-Almela S, Tulloch HE, Mistura M, Birnie DH, Wells GA, Nair GM, Hans H, Way KL, Chirico D, O'Neill CD, Pipe AL. Effect of High-Intensity Interval Training in Patients With Atrial Fibrillation: A Randomized Clinical Trial. JAMA Netw Open. 2022 Oct 3;5(10):e2239380. doi: 10.1001/jamanetworkopen.2022.39380.

  PMID: 36315143 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

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: November 3, 2015
• First Posted: November 11, 2015
• Study Start: November 1, 2015
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): October 1, 2030
• Last Updated: April 26, 2022

Record last verified: 2022-04

Locations

CA (1)