Clinical trial NCT02602457: Exercise Training in Patients With Atrial Fibrillation (OPPORTUNITY Study)
Official title: Exercise Training in Patients With Atrial Fibrillation (OPPORTUNITY Study)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2015-11-11
Enrollment: 94
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: Inclusion Criteria:

1. persistent or permanent atrial fibrillation;
2. rate controlled with a resting ventricular rate of equal to or less than 110 bpm;
3. able to perform a symptom-limited exercise test;
4. at least 40 years of age;
5. patient agrees to sign informed consent.

Exclusion Criteria:

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

Primary outcomes:
measure: Change in quality of life as measured by the Short-Form 36 questionnaire
timeFrame: baseline to 12 weeks
measure: Change in exercise capacity as measured by six-minute walk test distance
timeFrame: baseline to 12 weeks
Secondary outcomes:
measure: Change in exercise adherence measured by accelerometer
timeFrame: baseline to 12 weeks
measure: Change in activity status measured by the Duke Activity Status Index
timeFrame: baseline to 12 weeks
measure: Change in symptom burden measured by the Canadian Cardiovascular Society Severity of Atrial Fibrillation scale
timeFrame: baseline to 12 weeks
measure: Change in symptom frequency and severity measured using the 7-day symptom diary
timeFrame: baseline to 12 weeks
measure: Change in disease specific quality of life will be measured using the University of Toronto Atrial Fibrillation Severity Scale (AFSS)
timeFrame: baseline to 12 weeks
measure: Change in anxiety and depressive symptoms will be measured using the Hospital Anxiety and Depression Scale (HADS)
timeFrame: baseline to 12 weeks
measure: Change in sleep apnea risk will be measured by the STOP-BANG Sleep Apnea Questionnaire
timeFrame: baseline to 12 weeks
measure: Insomnia severity index will be measured using the Insomnia Severity Index
timeFrame: baseline to 12 weeks
measure: Change in self reported sleep patterns will be measured using a 7-day sleep diary
timeFrame: baseline to 12 weeks
measure: Change in heart rate control will be measured using 24-hour Holter ECG recordings and ECG recordings at each cardiopulmonary exercise test (CPET)
timeFrame: baseline to 12 weeks
measure: Change in muscular fitness will be measured using standard load tests
timeFrame: baseline to 12 weeks
measure: Change in exercise capacity will be measured using a cardiopulmonary exercise test (CPET)
timeFrame: baseline to 12 weeks
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Insititue
state: Ontario
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Jennifer L Reed, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.