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Exercise Training in Patients With Atrial Fibrillation (OPPORTUNITY Study)

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ClinicalTrials.gov Identifier: NCT02602457
Recruitment Status : Recruiting
First Posted : November 11, 2015
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation

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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Behavioral: moderate-intensity continuous exercise training Behavioral: high-intensity interval training Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Exercise Training in Patients With Atrial Fibrillation (OPPORTUNITY Study)
Study Start Date : November 2015
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Moderate-intensity continuous exercise
Moderate-intensity continuous exercise training
Behavioral: moderate-intensity continuous exercise training
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.

Experimental: High-Intensity Interval Training
High-Intensity Interval Training
Behavioral: high-intensity interval training
Participants will complete supervised exercise sessions. Participants will attend on-site high-intensity interval training two times weekly for 12 weeks.




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602457


Contacts
Contact: Jennifer L Reed, PhD 6136967392 JReed@ottawaheart.ca
Contact: Matheus Mistura, MSc 6136967000 ext 15944 mmistura@ottawaheart.ca

Locations
Canada, Ontario
University of Ottawa Heart Insititue Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Investigators
Principal Investigator: Jennifer L Reed, PhD Ottawa Heart Institute Research Corporation

Responsible Party: Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT02602457     History of Changes
Other Study ID Numbers: 20150427
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

Keywords provided by Ottawa Heart Institute Research Corporation:
Atrial Fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes