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

NCT03467633 | Terminated DMC

• 1 other identifier: 20170868
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (5)

• Feasibility - recruitment rates

  recruitment rates

  52-weeks

• Feasibility - loss to follow-up and drop-out rates

  loss to follow-up and drop-out rates

  52-weeks

• Feasibility - reasons for drop-out

  reasons for drop-out

  52-weeks

• Feasibility - adherence to study procedures

  adherence to study procedures including daily AliveCor measures

  52-weeks

• Feasibility - attendance at thrice-weekly HIIT sessions

  attendance at thrice-weekly HIIT sessions

  3-weeks

Secondary Outcomes (8)

• Time to recurrence of atrial fibrillation

  Up to 52 weeks after electro-cardioversion.

• Physical Activity levels

  3-weeks

• Fitness

  3-weeks

• Clinical outcomes

  3-weeks

• Weight

  3-weeks

Study Arms (2)

High-intensity interval training (HIIT)

EXPERIMENTAL

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.

Behavioral: High-intensity interval training

Usual Care Control

NO INTERVENTION

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

Interventions

High-intensity interval training 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.

High-intensity interval training (HIIT)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead
• Cardiac Arrhythmia Network of Canada: collaborator

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Z5P7, Canada

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jennifer L Reed, PhD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: March 16, 2018
• Study Start: April 25, 2018
• Primary Completion: October 8, 2020
• Study Completion: October 8, 2020
• Last Updated: November 2, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)