Clinical trial NCT03467633: Atrial Fibrillation Trial to Evade Recurrence: effectS of Hiit Before electrO-Cardioversion for 3-weeKs
Official title: Atrial Fibrillation Trial to Evade Recurrence: effectS of Hiit Before electrO-Cardioversion
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Persistent Atrial Fibrillation
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
Collaborators: name: Cardiac Arrhythmia Network of Canada
First posted: 2018-03-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility - recruitment rates
timeFrame: 52-weeks
measure: Feasibility - loss to follow-up and drop-out rates
timeFrame: 52-weeks
measure: Feasibility - reasons for drop-out
timeFrame: 52-weeks
measure: Feasibility - adherence to study procedures
timeFrame: 52-weeks
measure: Feasibility - attendance at thrice-weekly HIIT sessions
timeFrame: 3-weeks
Secondary outcomes:
measure: Time to recurrence of atrial fibrillation
timeFrame: Up to 52 weeks after electro-cardioversion.
measure: Physical Activity levels
timeFrame: 3-weeks
measure: Fitness
timeFrame: 3-weeks
measure: Clinical outcomes
timeFrame: 3-weeks
measure: Weight
timeFrame: 3-weeks
measure: Waist Circumference
timeFrame: 3-weeks
measure: Body Mass Index
timeFrame: 3-weeks
measure: Body Fat
timeFrame: 3-weeks
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Jennifer L Reed, PhD
role: PRINCIPAL_INVESTIGATOR
References: