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

Persistent Atrial Fibrillation Clinical Trial

— AFTERSHOCK  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03467633
• Other study ID #: 20170868
• Status: Terminated
• Phase: N/A
• Start date: April 25, 2018
• Est. completion date: October 8, 2020

Study information

• Verified date: October 2020
• Source: Ottawa Heart Institute Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: October 8, 2020
• Est. primary completion date: October 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation
• Recurrence

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation	Cardiac Arrhythmia Network of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility - recruitment rates	recruitment rates	52-weeks
Primary	Feasibility - loss to follow-up and drop-out rates	loss to follow-up and drop-out rates	52-weeks
Primary	Feasibility - reasons for drop-out	reasons for drop-out	52-weeks
Primary	Feasibility - adherence to study procedures	adherence to study procedures including daily AliveCor measures	52-weeks
Primary	Feasibility - attendance at thrice-weekly HIIT sessions	attendance at thrice-weekly HIIT sessions	3-weeks
Secondary	Time to recurrence of atrial fibrillation	Time to recurrence will be measured with a daily ECG recording up to 52-weeks from randomization, using the AliveCor system and Smartphone.	Up to 52 weeks after electro-cardioversion.
Secondary	Physical Activity levels	Participants will also be asked to complete a questionnaire related to habitual physical activity (modified Godin) at baseline and follow-up. The modified Godin asks participants to recall the last 7 days and report the number of days and the number of minutes per day they participated in mild, moderate and vigorous bouts of physical activity. These values are then multiplied together to calculate minutes/week of mild physical activity and minutes/ week of moderate-to-vigorous intensity physical activity.	3-weeks
Secondary	Fitness	Participants will complete a CPET at baseline and 3-weeks to assess fitness level using a pre-determined protocol on a cycle ergometer (Oxycon mobile, CareFusion, USA).	3-weeks
Secondary	Clinical outcomes	Body composition will be assessed: height	3-weeks
Secondary	Weight	Body composition will be assessed: weight	3-weeks
Secondary	Waist Circumference	Body composition will be assessed: waist circumference	3-weeks
Secondary	Body Mass Index	Body composition will be assessed: body mass index	3-weeks
Secondary	Body Fat	Body composition will be assessed:body fat percentage	3-weeks