This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Acute Responses to Exercise in Females and Males With Symptomatic Atrial Fibrillation (ACUTE-AF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05085860
Recruitment Status : Recruiting
First Posted : October 20, 2021
Last Update Posted : September 6, 2023
Sponsor:
Information provided by (Responsible Party):
Jennifer Reed, Ottawa Heart Institute Research Corporation

Brief Summary:
The main purpose of this pilot project is to measure the feasibility of conducting a randomized crossover study examining short-term changes in atrial fibrillation (AF) symptoms in symptomatic females and males with paroxysmal or persistent AF when they engage in a standard week of exercise (i.e. moderate-intensity continuous training [MICT] or high-intensity interval training [HIIT]) compared to a control week (i.e. no moderate to vigorous exercise over 7 days).

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Persistent Atrial Fibrillation Paroxysmal Atrial Fibrillation Behavioral: Moderate-intensity continuous training (MICT) Behavioral: High-intensity interval training (HIIT) Not Applicable

Detailed Description:

Exercise training (e.g. 8 to 12-week exercise programs) has been shown to improve cardiorespiratory fitness and QoL, and reduce atrial fibrillation (AF) symptoms and time in AF in patients with AF. However, regular exercise participation is hindered by patient concerns regarding an increase in AF symptoms and episodes during or following an exercise session. Patients with AF also worry about potential negative consequences of increasing heart rate during exercise. This fear may be sex-specific as females report more AF symptoms at rest, experience faster heart rates during exercise and AF, and report greater symptoms of fear/anxiety than males. How exercise acutely changes AF symptoms remains to be examined.

The main purpose of this pilot project is to measure the feasibility of conducting a randomized crossover study examining short-term changes in AF symptoms in symptomatic females and males with paroxysmal or persistent AF when they engage in a standard week of exercise (i.e. moderate-intensity continuous training [MICT] or high-intensity interval training [HIIT]) compared to a control week (i.e. no moderate to vigorous exercise over 7 days). As secondary outcomes we will explore sex differences in short-term changes in AF symptoms (self reported with a questionnaire) and AF status (device measured with a wireless four-finger AliveCor KardiaMobile ECG) when symptomatic patients with AF engage in a standard week of exercise (i.e. HIIT, MICT) compared to a control week. Results from this pilot study will provide novel insight into the typical acute response to exercise in females and males with AF, and will inform appropriate approaches for the conduct of a future larger trial. This work is key to informing practitioners and patients of the typical acute exercise response in the AF population with the goal of facilitating exercise prescription and participation.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This is a repeated measures randomized counter-balanced design. All participants will complete three conditions in a randomized order, with a wash-out week in between.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility of Examining Acute Responses to Exercise in Symptomatic Females and Males With Atrial Fibrillation: a Pilot Randomized Crossover Study
Actual Study Start Date : February 8, 2022
Estimated Primary Completion Date : April 1, 2024
Estimated Study Completion Date : April 1, 2024


Arm Intervention/treatment
Experimental: Moderate Intensity Continuous Training (MICT)
Participants will do 3 sessions of moderate-intensity continous exercise training over 7 days
Behavioral: Moderate-intensity continuous training (MICT)
Participants will engage in exercise and record AF symptoms prospectively over 7 days

Experimental: High Intensity Interval Training (HIIT)
Participants will do 3 sessions of high-intensity interval training over 7 days
Behavioral: High-intensity interval training (HIIT)
Participants will engage in exercise and record AF symptoms prospectively over 7 days

No Intervention: Rest
Participants will abstain from doing moderate- to high-intensity interval training over 7 days



Primary Outcome Measures :
  1. Feasibility of the pilot study - Recruitment and consent rate [ Time Frame: Through study completion, an average of 1.5 years ]
  2. Feasibility of the pilot study - Participant fidelity [ Time Frame: During the week of HIIT and MICT (2 weeks) ]
    E.g. ability of participants to comply with the exercise prescription, number of exercise sessions attended

  3. Feasibility of the pilot study - Study retention [ Time Frame: Through study completion, an average of 1.5 years ]
    Dropout rate of participants

  4. Feasibility of the pilot study - Study eligibility refinement [ Time Frame: Through study completion, an average of 1.5 years ]
    Data to refine inclusion and exclusion criteria for a larger trial will be used by balancing safety, ability to complete the intervention, and generalizability (e.g. is an exclusion criterion of threshold of participation in >2 structured exercise sessions/week sufficient or restrictive?)

  5. Feasibility of the pilot study - Adverse events [ Time Frame: Through study completion, an average of 1.5 years ]
    Side effects and adverse events during the study


Secondary Outcome Measures :
  1. AF symptoms self-reported with a 7-day patient symptom questionnaire [ Time Frame: 3 weeks (1 week of HIIT, 1 week of MICT, 1 week fo rest) ]

    Secondary objectives will explore sex differences in short-term changes in AF symptoms when symptomatic females and males with AF engage in a standard week of exercise (MICT or HIIT), compared to a control (rest) week.

    Participants will report AF symptoms prospectively during each condition. They will complete a 7-day questionnaire during MICT, a 7-day questionnaire during HIIT and a 7-day questionnaire during the rest week.


  2. AF status measured daily with a KardiaMobile device [ Time Frame: 3 weeks (1 week of HIIT, 1 week of MICT, 1 week fo rest) ]

    Secondary objectives will explore sex differences in short-term changes in AF status when symptomatic females and males with AF engage in a standard week of exercise (MICT or HIIT), compared to a control week.

    AF status will be measured with a Kardiamobile AliveCor wireless device. Participants will be asked to record 3 x 30-second ECGs a day (morning, afternoon, evening) during each condition (MICT, HIIT and rest). The ECG recording will allow the identification of whether the participant is in sinus rhythm or in atrial fibrillation.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Paroxysmal and Persistent AF
  • Rate controlled (resting ventricular rate <110 bpm)
  • Able to do a symptom limited exercise test
  • At least 40 years of age
  • Self-reports being symptomatic in the past 4 weeks
  • If female, self-reports being post-menopausal
  • Able to read and understand English or French
  • Agrees to sign informed consent

Exclusion Criteria:

  • Currently participating in routine exercise training
  • Unstable angina or uncontrolled diabetes mellitus; or established diagnosis of severe mitral or aortic stenosis, or hypertrophic obstructive cardiomyopathy with significant obstruction
  • Unable to access the Internet or a phone (iPhone and iPad require iOS version 10.0 and up, Android requires version 6.0 and up) during the study period
  • Has an automated external defibrillator, an implantable cardioverter defibrillator or other types of pacemaker
  • Unwilling or unable to complete the three conditions
  • Unable to provide written, informed consent

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): NCT05085860


Contacts
Layout table for location contacts
Contact: Sol Vidal Almela 613-696-7000 ext 14512 svidalalmela@ottawaheart.ca

Locations
Layout table for location information
Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y4W7
Contact: Jennifer L Reed, PhD    6136967392 ext 67392    jreed@ottawaheart.ca   
Contact: Matheus Mistura, MSc, BSc    6136967000 ext 15944    mmistura@ottawaheart.ca   
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Investigators
Layout table for investigator information
Principal Investigator: Jennifer Reed, PhD Ottawa Heart Institute Research Corporation
Layout table for additonal information
Responsible Party: Jennifer Reed, Scientist, Director, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT05085860    
Other Study ID Numbers: 20210524-01H
First Posted: October 20, 2021    Key Record Dates
Last Update Posted: September 6, 2023
Last Verified: September 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jennifer Reed, Ottawa Heart Institute Research Corporation:
Exercise
Sex differences
Pilot
Symptoms
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes