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Active, Not Recruiting

NCT Number: NCT02602457

Exercise Training in Patients With Atrial Fibrillation (OPPORTUNITY Study)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Ottawa Heart Insititue

Ottawa, Ontario, K1Y 4W7, Canada

About this study

Atrial fibrillation is the most common heart rhythm disorder. Significant disease and death rates are associated with atrial fibrillation because of stroke risk, the complications of medications, poor quality of life and reduced exercise tolerance. Many patients report they have a lower quality of life because of this condition, so finding new ways of helping patients manage and cope with this health problem may help a great number of people. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: baseline to 12 weeks

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

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

    Time frame: baseline to 12 weeks

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

Secondary outcomes

  1. Change in exercise adherence measured by accelerometer

    Time frame: baseline to 12 weeks

    Change in exercise adherence from baseline to 12 weeks as measured by accelerometer.

  2. Change in activity status measured by the Duke Activity Status Index

    Time frame: baseline to 12 weeks

    Change in activity status from baseline to 12 weeks as measured by the Duke Activity Status Index.

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

    Time frame: baseline to 12 weeks

    Change in symptom burden from baseline to 12 weeks as measured by the Canadian Cardiovascular Society Severity of Atrial Fibrillation scale.

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

    Time frame: baseline to 12 weeks

    Change in symptom frequency and severity from baseline to 12 weeks as measured using the the 7-day symptom diary.

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

    Time frame: baseline to 12 weeks

    Change in disease specific quality of life from baseline to 12 weeks will be measured using the University of Toronto Atrial Fibrillation Severity Scale (AFSS).

  6. Change in anxiety and depressive symptoms will be measured using the Hospital Anxiety and Depression Scale (HADS)

    Time frame: baseline to 12 weeks

    Change in anxiety and depressive symptoms from baseline to 12 weeks will be measured using the Hospital Anxiety and Depression Scale (HADS).

  7. Change in sleep apnea risk will be measured by the STOP-BANG Sleep Apnea Questionnaire

    Time frame: baseline to 12 weeks

    Change in risk of sleep apnea from baseline to 12 weeks will be measured by the STOP-BANG Sleep Apnea Questionnaire.

  8. Insomnia severity index will be measured using the Insomnia Severity Index

    Time frame: baseline to 12 weeks

    Insomnia severity index at baseline and 12 weeks will be measured using the Insomnia Severity Index.

  9. Change in self reported sleep patterns will be measured using a 7-day sleep diary

    Time frame: baseline to 12 weeks

    Change in self reported sleep patterns from baseline to 12 weeks will be measured using a 7-day sleep diary.

  10. Change in heart rate control will be measured using 24-hour Holter ECG recordings and ECG recordings at each cardiopulmonary exercise test (CPET)

    Time frame: baseline to 12 weeks

    Change in heart rate control from baseline to 12 weeks will be measured using 24-hour Holter ECG recordings and ECG recordings at each cardiopulmonary exercise test (CPET)

  11. Change in muscular fitness will be measured using standard load tests

    Time frame: baseline to 12 weeks

    Change in muscular fitness from baseline to 12 weeks will be measured using standard load tests.

  12. Change in exercise capacity will be measured using a cardiopulmonary exercise test (CPET)

    Time frame: baseline to 12 weeks

    Change in exercise capacity from baseline to 12 weeks will be measured using a cardiopulmonary exercise test (CPET)

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Registry information

Important dates

Study start
2015
Primary completion
2030
Study completion
2030
First posted
Nov 11, 2015
Registry last updated
Apr 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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