- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
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Ottawa, Ontario, Canada, K1Y 4W7
- University of Ottawa Heart Insititue
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Moderate-intensity continuous exercise
Moderate-intensity continuous exercise training
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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.
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Experimental: High-Intensity Interval Training
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Participants will complete supervised exercise sessions.
Participants will attend on-site high-intensity interval training two times weekly for 12 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in quality of life as measured by the Short-Form 36 questionnaire
Time Frame: baseline to 12 weeks
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Change in quality of life from baseline to 12 weeks as measured by the Short Form-36 questionnaire.
|
baseline to 12 weeks
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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.
|
baseline to 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline to 12 weeks
|
Change in activity status measured by the Duke Activity Status Index
Time Frame: baseline to 12 weeks
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Change in activity status from baseline to 12 weeks as 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
Time Frame: baseline to 12 weeks
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Change in symptom burden from baseline to 12 weeks as measured by the Canadian Cardiovascular Society Severity of Atrial Fibrillation scale.
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baseline to 12 weeks
|
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.
|
baseline to 12 weeks
|
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).
|
baseline to 12 weeks
|
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).
|
baseline to 12 weeks
|
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.
|
baseline to 12 weeks
|
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.
|
baseline to 12 weeks
|
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.
|
baseline to 12 weeks
|
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)
|
baseline to 12 weeks
|
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.
|
baseline to 12 weeks
|
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)
|
baseline to 12 weeks
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20150427
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Atrial Fibrillation
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Ablacon, Inc.CompletedArrhythmias, Cardiac | Atrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Longstanding Persistent Atrial FibrillationGermany
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Ablacon, Inc.RecruitingAtrial Fibrillation | Arrhythmias, Cardiac | Arrhythmia | Atrial Flutter | Atrial Fibrillation, Persistent | Atrial Tachycardia | Atrial Arrhythmia | Atrial Fibrillation Paroxysmal | Atrial Fibrillation, Paroxysmal or PersistentUnited States, Belgium, Netherlands, Czechia
-
Barts & The London NHS TrustAtriCure, Inc.Not yet recruitingAtrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Atrial Arrhythmia | Atrium; FibrillationUnited Kingdom
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AtriCure, Inc.Active, not recruitingPersistent Atrial Fibrillation | Atrial Fibrillation (AF) | Longstanding Persistent Atrial FibrillationUnited States
-
Maastricht University Medical CenterRWTH Aachen UniversityUnknownAtrial Fibrillation (Paroxysmal) | Atrial Fibrillation Recurrent | Atrial Fibrillation Common Gene VariantsNetherlands
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Adagio MedicalRecruitingAtrial Fibrillation | Atrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationNetherlands, Germany, Belgium
-
Vivek ReddyEnrolling by invitationAtrial Fibrillation and Flutter | Atrial Flutter Typical | Atrial Fibrillation, Paroxysmal or PersistentUnited States
-
Fundació Institut de Recerca de l'Hospital de la...RecruitingAtrial Arrhythmia | Atrial Fibrillation and Flutter | Atrial Fibrillation RecurrentSpain
-
St. George's Hospital, LondonRecruitingAtrial Fibrillation | Atrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Atrial ArrhythmiaUnited Kingdom
-
R-PharmFSBI "National Medical Research Center of Cardiology named after academician...CompletedAtrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationRussian Federation
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