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Trial record 40 of 101 for:    High Intensity Interval Training | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT03467633
Recruitment Status : Recruiting
First Posted : March 16, 2018
Last Update Posted : May 22, 2018
Sponsor:
Collaborator:
Cardiac Arrhythmia Network of Canada
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation

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), heart rate variability and habitual exercise levels. The entire study should last approximately 15-months. Participants will be involved for 52-weeks. The investigators are looking to recruit 40 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.

Condition or disease Intervention/treatment Phase
Persistent Atrial Fibrillation Behavioral: High-intensity interval training Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Atrial Fibrillation Trial to Evade Recurrence: effectS of Hiit Before electrO-Cardioversion
Actual Study Start Date : April 25, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.

No Intervention: Usual Care Control
Participants assigned to the control group will have usual care, which involves no behavioural interventions leading up to their electro-cardioversion.



Primary Outcome Measures :
  1. Feasibility - recruitment rates [ Time Frame: 52-weeks ]
    recruitment rates

  2. Feasibility - loss to follow-up and drop-out rates [ Time Frame: 52-weeks ]
    loss to follow-up and drop-out rates

  3. Feasibility - reasons for drop-out [ Time Frame: 52-weeks ]
    reasons for drop-out

  4. Feasibility - adherence to study procedures [ Time Frame: 52-weeks ]
    adherence to study procedures including daily AliveCor measures

  5. Feasibility - attendance at thrice-weekly HIIT sessions [ Time Frame: 3-weeks ]
    attendance at thrice-weekly HIIT sessions


Secondary Outcome Measures :
  1. Time to recurrence of atrial fibrillation [ Time Frame: Up to 52 weeks after electro-cardioversion. ]
    Time to recurrence will be measured with a daily ECG recording up to 52-weeks from randomization, using the AliveCor system and Smartphone.

  2. Clinical outcomes [ Time Frame: 3-weeks ]
    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. Clinical outcomes [ Time Frame: 3-weeks ]
    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).

  4. Clinical outcomes [ Time Frame: 3-weeks ]
    Continuous ECG will be recorded to measure vagal tone.

  5. Clinical outcomes [ Time Frame: 3-weeks ]
    Body composition will be assessed: height

  6. Clinical outcomes [ Time Frame: 3-weeks ]
    Body composition will be assessed: weight

  7. Clinical outcomes [ Time Frame: 3-weeks ]
    Body composition will be assessed: waist circumference

  8. Clinical outcomes [ Time Frame: 3-weeks ]
    Body composition will be assessed: body mass index

  9. Clinical outcomes [ Time Frame: 3-weeks ]
    Body composition will be assessed:body fat percentage



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 50-75 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03467633


Contacts
Contact: Jennifer L Reed, PhD 6136967000 ext 67392 jreed@ottawaheart.ca
Contact: Lisa M Cotie, PhD 6136967000 ext 67393 lcotie@ottawaheart.ca

Locations
Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Z5P7
Contact: Lisa Cotie, PhD    2893394373    lcotie@ottawaheart.ca   
Contact: Jennifer Reed, PhD    6136967000 ext 67392    jreed@ottawaheart.ca   
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Cardiac Arrhythmia Network of Canada
Investigators
Principal Investigator: Jennifer L Reed, PhD Ottawa Heart Institute Research Corporation

Responsible Party: Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT03467633     History of Changes
Other Study ID Numbers: 20170868
First Posted: March 16, 2018    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Atrial Fibrillation
Recurrence
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Disease Attributes