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Exercise Training in Patients With Atrial Fibrillation (OPPORTUNITY Study)

Primary Purpose

Atrial Fibrillation

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
moderate-intensity continuous exercise training
high-intensity interval training
Sponsored by
Ottawa Heart Institute Research Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Atrial Fibrillation focused on measuring Atrial Fibrillation

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Ottawa Heart Insititue

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Moderate-intensity continuous exercise

High-Intensity Interval Training

Arm Description

Moderate-intensity continuous exercise training

High-Intensity Interval Training

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Change in exercise adherence measured by accelerometer
Change in exercise adherence from baseline to 12 weeks as measured by accelerometer.
Change in activity status measured by the Duke Activity Status Index
Change in activity status from baseline to 12 weeks as measured by the Duke Activity Status Index.
Change in symptom burden measured by the Canadian Cardiovascular Society Severity of Atrial Fibrillation scale
Change in symptom burden from baseline to 12 weeks as measured by the Canadian Cardiovascular Society Severity of Atrial Fibrillation scale.
Change in symptom frequency and severity measured using the 7-day symptom diary
Change in symptom frequency and severity from baseline to 12 weeks as measured using the the 7-day symptom diary.
Change in disease specific quality of life will be measured using the University of Toronto Atrial Fibrillation Severity Scale (AFSS)
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).
Change in anxiety and depressive symptoms will be measured using the Hospital Anxiety and Depression Scale (HADS)
Change in anxiety and depressive symptoms from baseline to 12 weeks will be measured using the Hospital Anxiety and Depression Scale (HADS).
Change in sleep apnea risk will be measured by the STOP-BANG Sleep Apnea Questionnaire
Change in risk of sleep apnea from baseline to 12 weeks will be measured by the STOP-BANG Sleep Apnea Questionnaire.
Insomnia severity index will be measured using the Insomnia Severity Index
Insomnia severity index at baseline and 12 weeks will be measured using the Insomnia Severity Index.
Change in self reported sleep patterns will be measured using a 7-day sleep diary
Change in self reported sleep patterns from baseline to 12 weeks will be measured using a 7-day sleep diary.
Change in heart rate control will be measured using 24-hour Holter ECG recordings and ECG recordings at each cardiopulmonary exercise test (CPET)
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)
Change in muscular fitness will be measured using standard load tests
Change in muscular fitness from baseline to 12 weeks will be measured using standard load tests.
Change in exercise capacity will be measured using a cardiopulmonary exercise test (CPET)
Change in exercise capacity from baseline to 12 weeks will be measured using a cardiopulmonary exercise test (CPET)

Full Information

First Posted
November 3, 2015
Last Updated
April 25, 2022
Sponsor
Ottawa Heart Institute Research Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02602457
Brief Title
Exercise Training in Patients With Atrial Fibrillation (OPPORTUNITY Study)
Official Title
Exercise Training in Patients With Atrial Fibrillation (OPPORTUNITY Study)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2015 (undefined)
Primary Completion Date
January 2030 (Anticipated)
Study Completion Date
October 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Heart Institute Research Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial Fibrillation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moderate-intensity continuous exercise
Arm Type
Experimental
Arm Description
Moderate-intensity continuous exercise training
Arm Title
High-Intensity Interval Training
Arm Type
Experimental
Arm Description
High-Intensity Interval Training
Intervention Type
Behavioral
Intervention Name(s)
moderate-intensity continuous exercise training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
high-intensity interval training
Intervention Description
Participants will complete supervised exercise sessions. Participants will attend on-site high-intensity interval training two times weekly for 12 weeks.
Primary Outcome Measure Information:
Title
Change in quality of life as measured by the Short-Form 36 questionnaire
Description
Change in quality of life from baseline to 12 weeks as measured by the Short Form-36 questionnaire.
Time Frame
baseline to 12 weeks
Title
Change in exercise capacity as measured by six-minute walk test distance
Description
Change in exercise capacity from baseline to 12 weeks as measured by six-minute walk test distance.
Time Frame
baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Change in exercise adherence measured by accelerometer
Description
Change in exercise adherence from baseline to 12 weeks as measured by accelerometer.
Time Frame
baseline to 12 weeks
Title
Change in activity status measured by the Duke Activity Status Index
Description
Change in activity status from baseline to 12 weeks as measured by the Duke Activity Status Index.
Time Frame
baseline to 12 weeks
Title
Change in symptom burden measured by the Canadian Cardiovascular Society Severity of Atrial Fibrillation scale
Description
Change in symptom burden from baseline to 12 weeks as measured by the Canadian Cardiovascular Society Severity of Atrial Fibrillation scale.
Time Frame
baseline to 12 weeks
Title
Change in symptom frequency and severity measured using the 7-day symptom diary
Description
Change in symptom frequency and severity from baseline to 12 weeks as measured using the the 7-day symptom diary.
Time Frame
baseline to 12 weeks
Title
Change in disease specific quality of life will be measured using the University of Toronto Atrial Fibrillation Severity Scale (AFSS)
Description
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).
Time Frame
baseline to 12 weeks
Title
Change in anxiety and depressive symptoms will be measured using the Hospital Anxiety and Depression Scale (HADS)
Description
Change in anxiety and depressive symptoms from baseline to 12 weeks will be measured using the Hospital Anxiety and Depression Scale (HADS).
Time Frame
baseline to 12 weeks
Title
Change in sleep apnea risk will be measured by the STOP-BANG Sleep Apnea Questionnaire
Description
Change in risk of sleep apnea from baseline to 12 weeks will be measured by the STOP-BANG Sleep Apnea Questionnaire.
Time Frame
baseline to 12 weeks
Title
Insomnia severity index will be measured using the Insomnia Severity Index
Description
Insomnia severity index at baseline and 12 weeks will be measured using the Insomnia Severity Index.
Time Frame
baseline to 12 weeks
Title
Change in self reported sleep patterns will be measured using a 7-day sleep diary
Description
Change in self reported sleep patterns from baseline to 12 weeks will be measured using a 7-day sleep diary.
Time Frame
baseline to 12 weeks
Title
Change in heart rate control will be measured using 24-hour Holter ECG recordings and ECG recordings at each cardiopulmonary exercise test (CPET)
Description
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)
Time Frame
baseline to 12 weeks
Title
Change in muscular fitness will be measured using standard load tests
Description
Change in muscular fitness from baseline to 12 weeks will be measured using standard load tests.
Time Frame
baseline to 12 weeks
Title
Change in exercise capacity will be measured using a cardiopulmonary exercise test (CPET)
Description
Change in exercise capacity from baseline to 12 weeks will be measured using a cardiopulmonary exercise test (CPET)
Time Frame
baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer L Reed, PhD
Organizational Affiliation
Ottawa Heart Institute Research Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ottawa Heart Insititue
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
36315143
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.
Results Reference
derived

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Exercise Training in Patients With Atrial Fibrillation (OPPORTUNITY Study)

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