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Atrial Fibrillation Trial to Evade Recurrence: effectS of Hiit Before electrO-Cardioversion for 3-weeKs

NCT ID: NCT03467633

Last Updated: 2020-11-02

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

TERMINATED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-25

Study Completion Date

2020-10-08

Brief Summary

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This is a study looking at the feasibility of conducting a larger definitive research trial looking at the effectiveness of high intensity interval training in individuals who are scheduled for electro-cardioversion. Usual care for these participants is to go home and continue with their typical daily routine. The investigators will test whether participating in 3-weeks of thrice-weekly high intensity interval training before electro-cardioversion can lengthen the time to recurrence of atrial fibrillation after electro-cardioversion in these individuals. Participants will be asked to come to the University of Ottawa Heart Institute for a baseline visit at which fitness (cycle ergometer), body composition (weight, height, waist circumference and percentage body fat), heart rate variability and habitual exercise levels will be measured. Participants will then be randomized to either the exercise group or the usual care group. Those randomized to the usual care group will go home for 3-weeks and continue with their typical daily routine. Those randomized to the exercise group will return to the Heart Institute three times per week for 3-weeks to participate in a high intensity interval training program prior to their electro-cardioversion. All participants will be asked to measure daily heart rate and rhythm using the AliveCor system which is compatible with their Smartphones, for up to 12-months following their electro-cardioversion. All participants will be asked to return at 3-weeks (and prior to their electro-cardioversion) to measure fitness (cycle ergometer), body composition (weight, height, waist circumference and percentage body fat), and habitual exercise levels. The entire study should last approximately 24-months. Participants will be involved for 52-weeks. The investigators are looking to recruit 20 participants total for the feasibility trial. The investigators hypothesize that recruitment rates, drop-out rates, and adherence to the intervention will support a larger definitive trial.

Detailed Description

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This is a study looking at the feasibility of conducting a larger definitive research trial looking at the effectiveness of high intensity interval training on lengthening time to recurrence of persistent atrial fibrillation in individuals who are scheduled for electro-cardioversion. Usual care for these participants is to go home and continue with their typical daily routine until their scheduled cardioversion. The investigators will test whether participating in 3-weeks of thrice-weekly high intensity interval training before electro-cardioversion can lengthen the time to recurrence of atrial fibrillation after electro-cardioversion in these individuals. Participants will be asked to come to the University of Ottawa Heart Institute for a baseline visit at which fitness (cycle ergometer), body composition (weight, height, waist circumference and percentage body fat), and habitual exercise levels will be measured. Participants will then be randomized to either the exercise group or the usual care group. Those randomized to the usual care group will go home for 3-weeks and continue with their typical daily routine. Those randomized to the exercise group will return to the Heart Institute three times per week for 3-weeks to participate in a high intensity interval training cycle ergometer program prior to their electro-cardioversion. All participants will be asked to return at 3-weeks (and prior to their electro-cardioversion) to measure fitness (cycle ergometer), body composition (weight, height, waist circumference and percentage body fat), and habitual exercise levels. Following the electro-cardioversion, all participants will be asked to measure daily heart rate and rhythm using the AliveCor system which is compatible with their Smartphones/tablets/iPads, for up to 12-months or until they return to persistent atrial fibrillation. The entire study should last approximately 24-months. Participants will be involved for a maximum of 52-weeks. The investigators are looking to recruit a total of 20 participants for the feasibility trial. The investigators hypothesize that recruitment rates, drop-out rates, and adherence to the intervention will support a larger definitive trial.

Conditions

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Persistent 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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High-intensity interval training (HIIT)

Participants in the HIIT group will receive 3-weeks of tri-weekly supervised exercise sessions at the University of Ottawa Heart Institute prior to their scheduled electro-cardioversion. The session will last 23 minutes in duration and consist of a 2-minute warm-up at 50% of peak power output (PPO), 2 x 8-minute interval training blocks of 30 seconds at 80-100% of PPO interspersed with 30-seconds of active recovery and a 1-minute cool down at 25 % of PPO. The sessions will be lead by a Registered Kinesiologist.

Group Type EXPERIMENTAL

High-intensity interval training

Intervention Type BEHAVIORAL

Participants in the HIIT group will receive 3-weeks of tri-weekly supervised exercise sessions at the UOHI prior to their scheduled electro-cardioversion. The session will last 23 minutes in duration and consist of a 2-minute warm-up at 50% of peak power output (PPO), 2 x 8-minute interval training blocks of 30 seconds at 80-100% of PPO interspersed with 30-seconds of active recovery and a 1-minute cool down at 25 % of PPO. The sessions will be lead by a Registered Kinesiologist.

Usual Care Control

Participants assigned to the control group will have usual care, which involves no behavioural interventions leading up to their electro-cardioversion.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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High-intensity interval training

Participants in the HIIT group will receive 3-weeks of tri-weekly supervised exercise sessions at the UOHI prior to their scheduled electro-cardioversion. The session will last 23 minutes in duration and consist of a 2-minute warm-up at 50% of peak power output (PPO), 2 x 8-minute interval training blocks of 30 seconds at 80-100% of PPO interspersed with 30-seconds of active recovery and a 1-minute cool down at 25 % of PPO. The sessions will be lead by a Registered Kinesiologist.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Persistent atrial fibrillation
2. Eligible and scheduled for electro-cardioversion at UOHI
3. Rate controlled with a resting ventricular rate of equal to or less than 100bpm
4. Between 18-85 years of age
5. Owns a Smartphone
6. Physically able to participate in exercise
7. Willing and able to provide written, informed consent
8. Willing and able to return for follow-up visits
9. Willing and able to provide daily ECG recordings using the AliveCor system for the duration of the study.

Exclusion Criteria

1. Participating in routine exercise training (more than two times per week) in the past 3 months
2. Atrial Flutter secondary to ablation
3. Unstable angina
4. Diagnosed with severe mitral or aortic stenosis, hypertrophic obstructive cardiomyopathy
5. Pregnant, lactating or planning to become pregnant during the study period
6. Diagnosed with rheumatic heart disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardiac Arrhythmia Network of Canada

OTHER

Sponsor Role collaborator

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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University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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20170868

Identifier Type: -

Identifier Source: org_study_id