Exercise Training in Patients With Persistent or Permanent Atrial Fibrillation

NCT ID: NCT03397602

Last Updated: 2024-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-23

Study Completion Date

2034-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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standard care

Participants do not participate in a on site structured exercise training program.

Group Type NO_INTERVENTION

No interventions assigned to this group

standard care + MICE

standard care + moderate-intensity continuous exercise training (MICE)

Group Type EXPERIMENTAL

standard care + moderate-intensity continuous exercise training

Intervention Type BEHAVIORAL

Participants will attend on-site moderate-intensity continuous exercise training two times weekly for 12 weeks.

standard care + HIIT

standard care + high-intensity interval training (HIIT)

Group Type EXPERIMENTAL

standard care + high-intensity interval training

Intervention Type BEHAVIORAL

Participants will attend on-site high-intensity interval training two times weekly for 12 weeks.

Interventions

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standard care + moderate-intensity continuous exercise training

Participants will attend on-site moderate-intensity continuous exercise training two times weekly for 12 weeks.

Intervention Type BEHAVIORAL

standard care + high-intensity interval training

Participants will attend on-site high-intensity interval training two times weekly for 12 weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer L Reed, PhD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Heart Institute Research Corporation

Locations

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London Health Sciences Network

London, Ontario, Canada

Site Status RECRUITING

University of Ottawa Heart Insititue

Ottawa, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Jennifer L Reed, PhD

Role: CONTACT

613-696-7392

Matheus Mistura, MSc

Role: CONTACT

613-696-7000 ext. 15944

Other Identifiers

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0906

Identifier Type: -

Identifier Source: org_study_id

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