Clinical trial NCT05085860: Acute Responses to Exercise in Females and Males With Symptomatic Atrial Fibrillation
Official title: Feasibility of Examining Acute Responses to Exercise in Symptomatic Females and Males With Atrial Fibrillation: a Pilot Randomized Crossover Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Persistent Atrial Fibrillation
Paroxysmal Atrial Fibrillation
Keywords: Exercise
Sex differences
Pilot
Symptoms
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2021-10-20
Enrollment: 36
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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).

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.

Eligibility 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

Primary outcomes:
measure: Feasibility of the pilot study - Recruitment and consent rate
timeFrame: Through study completion, an average of 1.5 years
measure: Feasibility of the pilot study - Participant fidelity
timeFrame: During the week of HIIT and MICT (2 weeks)
measure: Feasibility of the pilot study - Study retention
timeFrame: Through study completion, an average of 1.5 years
measure: Feasibility of the pilot study - Study eligibility refinement
timeFrame: Through study completion, an average of 1.5 years
measure: Feasibility of the pilot study - Adverse events
timeFrame: Through study completion, an average of 1.5 years
Secondary outcomes:
measure: AF symptoms self-reported with a 7-day patient symptom questionnaire
timeFrame: 3 weeks (1 week of HIIT, 1 week of MICT, 1 week fo rest)
measure: AF status measured daily with a KardiaMobile device
timeFrame: 3 weeks (1 week of HIIT, 1 week of MICT, 1 week fo rest)
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 Reed, PhD
role: PRINCIPAL_INVESTIGATOR
References: