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

Primary Purpose

Persistent Atrial Fibrillation

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
High-intensity interval training
Sponsored by
Ottawa Heart Institute Research Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Persistent Atrial Fibrillation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Ottawa Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

High-intensity interval training (HIIT)

Usual Care Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Feasibility - recruitment rates
recruitment rates
Feasibility - loss to follow-up and drop-out rates
loss to follow-up and drop-out rates
Feasibility - reasons for drop-out
reasons for drop-out
Feasibility - adherence to study procedures
adherence to study procedures including daily AliveCor measures
Feasibility - attendance at thrice-weekly HIIT sessions
attendance at thrice-weekly HIIT sessions

Secondary Outcome Measures

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.
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.
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).
Clinical outcomes
Body composition will be assessed: height
Weight
Body composition will be assessed: weight
Waist Circumference
Body composition will be assessed: waist circumference
Body Mass Index
Body composition will be assessed: body mass index
Body Fat
Body composition will be assessed:body fat percentage

Full Information

First Posted
February 13, 2018
Last Updated
October 29, 2020
Sponsor
Ottawa Heart Institute Research Corporation
Collaborators
Cardiac Arrhythmia Network of Canada
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1. Study Identification

Unique Protocol Identification Number
NCT03467633
Brief Title
Atrial Fibrillation Trial to Evade Recurrence: effectS of Hiit Before electrO-Cardioversion for 3-weeKs
Acronym
AFTERSHOCK
Official Title
Atrial Fibrillation Trial to Evade Recurrence: effectS of Hiit Before electrO-Cardioversion
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Why Stopped
Not enough participants recruited.
Study Start Date
April 25, 2018 (Actual)
Primary Completion Date
October 8, 2020 (Actual)
Study Completion Date
October 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Heart Institute Research Corporation
Collaborators
Cardiac Arrhythmia Network of Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-intensity interval training (HIIT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care Control
Arm Type
No Intervention
Arm Description
Participants assigned to the control group will have usual care, which involves no behavioural interventions leading up to their electro-cardioversion.
Intervention Type
Behavioral
Intervention Name(s)
High-intensity interval training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility - recruitment rates
Description
recruitment rates
Time Frame
52-weeks
Title
Feasibility - loss to follow-up and drop-out rates
Description
loss to follow-up and drop-out rates
Time Frame
52-weeks
Title
Feasibility - reasons for drop-out
Description
reasons for drop-out
Time Frame
52-weeks
Title
Feasibility - adherence to study procedures
Description
adherence to study procedures including daily AliveCor measures
Time Frame
52-weeks
Title
Feasibility - attendance at thrice-weekly HIIT sessions
Description
attendance at thrice-weekly HIIT sessions
Time Frame
3-weeks
Secondary Outcome Measure Information:
Title
Time to recurrence of atrial fibrillation
Description
Time to recurrence will be measured with a daily ECG recording up to 52-weeks from randomization, using the AliveCor system and Smartphone.
Time Frame
Up to 52 weeks after electro-cardioversion.
Title
Physical Activity levels
Description
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.
Time Frame
3-weeks
Title
Fitness
Description
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).
Time Frame
3-weeks
Title
Clinical outcomes
Description
Body composition will be assessed: height
Time Frame
3-weeks
Title
Weight
Description
Body composition will be assessed: weight
Time Frame
3-weeks
Title
Waist Circumference
Description
Body composition will be assessed: waist circumference
Time Frame
3-weeks
Title
Body Mass Index
Description
Body composition will be assessed: body mass index
Time Frame
3-weeks
Title
Body Fat
Description
Body composition will be assessed:body fat percentage
Time Frame
3-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer L Reed, PhD
Organizational Affiliation
Ottawa Heart Institute Research Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Z5P7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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