Exercise Training in Patients With Persistent or Permanent Atrial Fibrillation (Exercise-AF)

September 5, 2023 updated by: Ottawa Heart Institute Research Corporation

Exercise Training in Patients With Persistent or Permanent Atrial Fibrillation - a Multi-centre Randomized Controlled Trial

The main purpose of this project is to evaluate the effects of high-intensity interval training (HIIT) compared to moderate-intensity continuous exercise training (MICE) and standard care on exercise capacity and quality of life in patients with persistent or permanent atrial fibrillation. Positive findings are vitally important for these patients, given the condition's substantial morbidity, mortality and high economic costs.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Recommended standards of care do not include the prescription of exercise to target and ameliorate the progressive health decline and overall feeling of well-being in patients with atrial fibrillation. Recent Standards for the Provision of Cardiac Rehabilitation of Ontario are calling for the consideration for referral and enrollment of patients with atrial fibrillation in cardiovascular rehabilitation - evidence is needed to support and confirm these efforts. The main purpose of this project is to evaluate the effects of high-intensity interval training (HIIT) compared to moderate-intensity continuous exercise training (MICE) and standard care on exercise capacity and quality of life in patients with persistent or permanent atrial fibrillation. Positive results from this study will identify a new intervention that: produces important improvements in patient-rated clinical, behavioural and exercise outcomes; provides mechanistic insight into the role of exercise training in the management of atrial fibrillation; requires minimal equipment; and, is appealing to patients with atrial fibrillation.

Study Type

Interventional

Enrollment (Estimated)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada
        • Recruiting
        • London Health Sciences Network
      • Ottawa, Ontario, Canada, K1Y 4W7
        • Recruiting
        • University of Ottawa Heart Insititue

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. persistent or permanent atrial fibrillation;
  2. rate controlled with a resting ventricular rate of equal to or less than 100 bpm;
  3. able to perform a symptom-limited exercise test;
  4. at least 40 years of age (i.e. participants must be 40 years or older);

Exclusion Criteria:

  1. currently participating in routine exercise training (more than two times per week);
  2. unstable angina;
  3. diagnosed severe mitral or aortic stenosis;
  4. diagnosed hypertrophic obstructive cardiomyopathy with significant obstruction;
  5. pregnant, lactating or planning to become pregnant during the study period;
  6. unable to provide written, informed consent, or
  7. unwilling or unable to return for follow up at week 12.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
No Intervention: standard care
Participants do not participate in a on site structured exercise training program.
Experimental: standard care + MICE
standard care + moderate-intensity continuous exercise training (MICE)
Behavioral: standard care + moderate-intensity continuous exercise training
Participants will attend on-site moderate-intensity continuous exercise training two times weekly for 12 weeks.
Experimental: standard care + HIIT
standard care + high-intensity interval training (HIIT)
Behavioral: standard care + high-intensity interval training
Participants will attend on-site high-intensity interval training two times weekly for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in quality of life measured by the physical component summary (PCS) measure of the Short Form 36 Health Survey Questionnaire (SF-36).
Time Frame: baseline to 12 weeks
Changes in quality of life measured by the physical component summary (PCS) measure of the Short Form 36 Health Survey Questionnaire (SF-36) from baseline to 12 weeks.
baseline to 12 weeks
Changes in exercise capacity measured by VO2peak on a symptom-limited cardiopulmonary exercise test (CPET).
Time Frame: baseline to 12 weeks
Changes in exercise capacity measured by VO2peak on a symptom-limited cardiopulmonary exercise test (CPET) from baseline to 12 weeks.
baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes atrial fibrillation specific quality of life measured by the Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT).
Time Frame: baseline to 12 weeks
Changes atrial fibrillation specific quality of life measured by the Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT). The AFEQT assesses 4 domains: symptoms, activities, treatment concern, treatment satisfaction, and a summary score that includes the first 3 domains. Patients will assess the impact of AF on their health status during the previous 4 weeks. Responses are presented as a 7-point Likert scale. Raw scores within each domain are transformed to a 0 (most severe symptoms) to 100 scale (no limitations or disability). The AFEQT is valid, reliable and sensitive to clinical change in patients with AF undergoing different therapeutic interventions.
baseline to 12 weeks
Changes atrial fibrillation specific quality of life measured by the University of Toronto Atrial Fibrillation Severity Scale (AFSS).
Time Frame: baseline to 12 weeks
Changes atrial fibrillation specific quality of life measured by the University of Toronto Atrial Fibrillation Severity Scale (AFSS) from baseline to 12 weeks. The AFSS is a disease-specific quality of life measure used to capture subjective and objective ratings of disease burden in patients with atrial fibrillation. It assesses atrial fibrillation burden (score 1-30; higher scores indicate higher burden); Global Well Being (a visual analogue scale ranging from 1-10, indicating a patient reports as having a worst possible life [0] to the best possible life[10]); AF symptom score (score of 0-35; higher scores indicate more bothered by AF symptoms); and health care utilization (score of 0-21; higher scores indicate greater health care utilization).
baseline to 12 weeks
Changes in symptom burden measured by the Canadian Cardiovascular Society Severity of Atrial Fibrillation Scale.
Time Frame: baseline to 12 weeks
Changes in symptom burden measured by the Canadian Cardiovascular Society Severity of Atrial Fibrillation Scale from baseline to 12 weeks.The CCS-SAF is a simple, concise, symptom-based severity scale to assess patient status. CCS-SAF scores range from 0 to 4, with highest values denoting severe impact of symptoms on quality of life and activities of daily living. The CCS-SAF has been validated in patients with atrial fibrillation.
baseline to 12 weeks
Changes in quality of life measured by the mental component summary (MCS) measure of the Short Form 36 Health Survey Questionnaire (SF-36).
Time Frame: baseline to 12 weeks
Changes in quality of life measured by the mental component summary (MCS) measure of the Short Form 36 Health Survey Questionnaire (SF-36) from baseline to 12 weeks. The SF-36 is a widely used and thoroughly validated, standardized, generic health survey with 36 questions. It yields an 8-scale (physical functioning; role-physical; bodily pain; general health; vitality; social functioning; role-emotional; and, mental health) profile of functional health and well-being scores as well as psychometrically-based physical (PCS) and mental (MCS) component summary scores.
baseline to 12 weeks
Changes in heart rate control measured by 24-hour Holter ECG recordings and ECG recordings at each CPET.
Time Frame: baseline to 12 weeks
Changes in heart rate control measured by 24-hour Holter ECG recordings and ECG recordings at each CPET from baseline to 12 weeks.
baseline to 12 weeks
Changes in lower body muscular fitness measured by standard load tests.
Time Frame: baseline to 12 weeks
Changes in lower body muscular fitness measured by standard load tests from baseline to 12 weeks.
baseline to 12 weeks
Changes in volume and intensity of exercise measured directly by accelerometer.
Time Frame: baseline to 12 weeks
Changes in volume and intensity of exercise measured directly by accelerometer from baseline to 12 weeks.
baseline to 12 weeks
Changes in volume and intensity of exercise measured by self-report (exercise logs).
Time Frame: baseline to 12 weeks
Changes in volume and intensity of exercise measured by self-report (exercise logs) from baseline to 12 weeks.
baseline to 12 weeks
Changes in self-reported symptom frequency and severity measured by the 7-day symptom diary.
Time Frame: baseline to 12 weeks
Changes in self-reported symptom frequency and severity measured by the 7-day symptom diary from baseline to 12 weeks.
baseline to 12 weeks
Changes in self reported sleep patterns measured by the 7-day sleep diary.
Time Frame: baseline to 12 weeks
Changes in self reported sleep patterns measured by the 7-day sleep diary from baseline to 12 weeks.
baseline to 12 weeks
Changes in blood biomarker concentrations (participants at the University of Ottawa Heart Institute site only).
Time Frame: baseline to 12 weeks
Changes in blood biomarker concentrations from baseline to 12 weeks (participants at the University of Ottawa Heart Institute site only).
baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Heart Institute Research Corporation

Investigators

  • Principal Investigator: Jennifer L Reed, PhD, Ottawa Heart Institute Research Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2019

Primary Completion (Estimated)

December 30, 2023

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

January 4, 2018

First Submitted That Met QC Criteria

January 10, 2018

First Posted (Actual)

January 12, 2018

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 5, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0906

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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