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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;
Must not have
Unstable angina
Diagnosed severe mitral or aortic stenosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 weeks
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 40 years old or older.
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I have ongoing or permanent irregular heartbeats.
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I have ongoing or permanent irregular heartbeats.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have unstable chest pain.
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I have been diagnosed with severe narrowing of my heart's mitral or aortic valve.
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I have been diagnosed with a thickened heart muscle that obstructs blood flow.
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I cannot come back for a follow-up in 12 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Find a Location

Who is running the clinical trial?

Ottawa Heart Institute Research CorporationLead Sponsor
195 Previous Clinical Trials
93,368 Total Patients Enrolled
24 Trials studying Atrial Fibrillation
6,914 Patients Enrolled for Atrial Fibrillation
Jennifer L Reed, PhDPrincipal InvestigatorOttawa Heart Institute Research Corporation
6 Previous Clinical Trials
493 Total Patients Enrolled
4 Trials studying Atrial Fibrillation
318 Patients Enrolled for Atrial Fibrillation

Media Library

standard care + moderate-intensity continuous exercise training Clinical Trial Eligibility Overview. Trial Name: NCT03397602 — N/A
Atrial Fibrillation Research Study Groups: standard care, standard care + MICE, standard care + HIIT
Atrial Fibrillation Clinical Trial 2023: standard care + moderate-intensity continuous exercise training Highlights & Side Effects. Trial Name: NCT03397602 — N/A
standard care + moderate-intensity continuous exercise training 2023 Treatment Timeline for Medical Study. Trial Name: NCT03397602 — N/A
~2 spots leftby Dec 2024
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