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Exercise Training for Atrial Fibrillation (Exercise-AF Trial)
N/A
Recruiting
Led By Jennifer L Reed, PhD
Research Sponsored by Ottawa Heart Institute Research Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 40 years of age
persistent or permanent atrial fibrillation;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 weeks
Awards & highlights
Exercise-AF Trial Summary
This trial will compare the effects of HIIT vs. MICE vs. standard care on exercise capacity and quality of life in patients with atrial fibrillation.
Who is the study for?
This trial is for adults over 40 with persistent or permanent atrial fibrillation, who can exercise and have a resting heart rate of 100 bpm or less. It's not for those who already exercise regularly, have unstable angina, severe valve disease, obstructive cardiomyopathy, are pregnant or breastfeeding, or can't consent to follow-ups.Check my eligibility
What is being tested?
The study compares the effects of two types of exercise on people with atrial fibrillation: moderate-intensity continuous training (MICE) versus high-intensity interval training (HIIT), in addition to standard care. The focus is on how these exercises affect fitness levels and quality of life.See study design
What are the potential side effects?
Exercise programs may cause muscle soreness, fatigue, and in rare cases could trigger heart-related symptoms due to the underlying condition. Participants will be monitored closely for any adverse reactions.
Exercise-AF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 40 years old or older.
Select...
I have ongoing or permanent irregular heartbeats.
Select...
I have ongoing or permanent irregular heartbeats.
Exercise-AF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in exercise capacity measured by VO2peak on a symptom-limited cardiopulmonary exercise test (CPET).
Changes in quality of life measured by the physical component summary (PCS) measure of the Short Form 36 Health Survey Questionnaire (SF-36).
Secondary outcome measures
Changes atrial fibrillation specific quality of life measured by the Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT).
Changes atrial fibrillation specific quality of life measured by the University of Toronto Atrial Fibrillation Severity Scale (AFSS).
Changes in blood biomarker concentrations (participants at the University of Ottawa Heart Institute site only).
+8 moreExercise-AF Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: standard care + MICEExperimental Treatment1 Intervention
standard care + moderate-intensity continuous exercise training (MICE)
Group II: standard care + HIITExperimental Treatment1 Intervention
standard care + high-intensity interval training (HIIT)
Group III: standard careActive Control1 Intervention
Participants do not participate in a on site structured exercise training program.
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Who is running the clinical trial?
Ottawa Heart Institute Research CorporationLead Sponsor
188 Previous Clinical Trials
92,304 Total Patients Enrolled
23 Trials studying Atrial Fibrillation
6,559 Patients Enrolled for Atrial Fibrillation
Jennifer L Reed, PhDPrincipal InvestigatorOttawa Heart Institute Research Corporation
6 Previous Clinical Trials
517 Total Patients Enrolled
4 Trials studying Atrial Fibrillation
342 Patients Enrolled for Atrial Fibrillation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You can do a test that measures your ability to exercise without getting too tired or feeling unwell.I have unstable chest pain.I have been diagnosed with severe narrowing of my heart's mitral or aortic valve.You can do a test where you exercise until you feel symptoms.I have been diagnosed with a thickened heart muscle that obstructs blood flow.I cannot come back for a follow-up in 12 weeks.I am 40 years old or older.I have ongoing or permanent irregular heartbeats.I have ongoing or permanent irregular heartbeats.Your heart beats at a rate of 100 beats per minute or less when you are at rest.You regularly exercise more than twice a week.
Research Study Groups:
This trial has the following groups:- Group 1: standard care
- Group 2: standard care + MICE
- Group 3: standard care + HIIT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies available for the participants of this trial?
"According to clinicaltrials.gov, recruitment for this clinicial trial is ongoing since its post on the 23rd of January 2019 and subsequent editing in December 2021."
Answered by AI
What are the objectives of this research endeavor?
"The primary aim of this clinical trial, assessed at baseline and 12 weeks, is to evaluate the changes in quality of life using the PCS measure from the SF-36 Health Survey Questionnaire. Secondary objectives include evaluating fluctuations in symptom frequency/severity with a 7-day diary; quantifying physical activity levels through an accelerometer device; and gauging AF's impact on wellbeing via responses to 4 domains (symptoms, activities, treatment concern & satisfaction) in the Atrial fibrillation Effect on Quality of Life Questionnaire. The latter will be reported as a 0 - 100 scale where lower scores reflect more severe symptoms."
Answered by AI
How many individuals have enrolled in this medical experiment thus far?
"Indeed, the information hosted on clinicaltrials.gov verifies this medical research is in its recruitment phase. The posting of the study was published on January 23rd 2019 and has been modified as recently as December 15th 2021. 132 participants are required to be enrolled from two different locations."
Answered by AI
Who else is applying?
What state do they live in?
New York
What portion of applicants met pre-screening criteria?
Did not meet criteria
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