Clinical trial NCT05946304: Exercise Training in Women With Cardiac Devices
Official title: The Effects of Exercise Training on Physical and Mental Health in Women With Cardiac Implantable Electronic Devices (CIED-EX): a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cardiac implantable electronic devices (CIED) are established treatments for a variety of cardiac arrhythmias. Women with CIED have lower fitness and lower quality of life compared to men with CIED. Moderate-intensity continuous training (MICT) is the most prescribed exercise for women. However, high-intensity interval training (HIIT) has been shown to improve fitness, anxiety levels, quality of life, and other health indicators over MICT in men with CIED. There is a need to quantitatively evaluate the feasibility and effects of a virtual HIIT vs. virtual MICT program on the physical, quality of life, and mental health of women with CIED. Furthermore, a qualitative approach is also necessary to understand patients' experiences, barriers, and facilitators of a virtual exercise intervention. This mixed-methods pilot randomized controlled trial will assess the feasibility of a 12-week virtual HIIT and MICT program in women with CIED.


Eligibility criteria: Inclusion Criteria:

1. Women (i.e., female sex assigned at birth) with CIED (≥6 months since implant)
2. Women with CIED in optimal medical therapy and functioning;
3. Patient is able to perform a symptom-limited CPET;
4. Patient is able to read and understand English or French.

Exclusion Criteria:

1. Patient is currently participating in routine exercise training (\>2x/week);
2. Patient has: documented unstable angina; or established diagnosis of chronic obstructive pulmonary disease, severe mitral or aortic stenosis, or hypertrophic obstructive cardiomyopathy;
3. Patient has an unmanaged psychiatric illness (e.g., active psychosis, suicidal ideation) or cognitive impairment;
4. Patient does not have an internet connection or a device with a camera and speakers;
5. Patient with any device troubleshooting at resting or during exercise;
6. Patient is unable to provide written informed consent;
7. Patient is unwilling or unable to return for follow-up visits at week 12;
8. Patient is unwilling to be randomized to HIIT or MICT; or
9. Pregnancy or patients who become pregnant during the 12-week intervention phase (the effects of interval training on an unborn fetus are unknown).

Primary outcomes:
measure: Feasibility - Number of classes participants attended
timeFrame: Week 12
measure: Feasibility - Compliance to the exercise prescription based on heart rate
timeFrame: Week 12
measure: Feasibility - Adverse events
timeFrame: Week 12
measure: Feasibility - Number of dropouts
timeFrame: Week 12
Secondary outcomes:
measure: Exercise capacity - maximal oxygen uptake (VO2peak)
timeFrame: Baseline
measure: Exercise capacity - maximal oxygen uptake (VO2peak)
timeFrame: Week 6
measure: Exercise capacity - maximal oxygen uptake (VO2peak)
timeFrame: Following 12-weeks of intervention
measure: Quality of life (self-reported)
timeFrame: Baseline
measure: Quality of life (self-reported)
timeFrame: Following 12-weeks of intervention
measure: Mental health - Anxiety levels
timeFrame: Baseline
measure: Mental health - Anxiety levels
timeFrame: Following 12-weeks of intervention
measure: Mental health - Depression levels
timeFrame: Baseline and following 12-weeks of intervention
measure: Mental health - Depression levels
timeFrame: Following 12-weeks of intervention
measure: Cardiometabolic health indicators - Blood pressure
timeFrame: Baseline
measure: Cardiometabolic health indicators - Blood pressure
timeFrame: Following 12-weeks of intervention
measure: Cardiometabolic health indicators - Heart rate
timeFrame: Baseline
measure: Cardiometabolic health indicators - Heart rate
timeFrame: Following 12-weeks of intervention
measure: Cardiometabolic health indicators - Body mass index
timeFrame: Baseline
measure: Cardiometabolic health indicators - Body mass index
timeFrame: Following 12-weeks of intervention
measure: Cardiometabolic health indicators - Fat mass
timeFrame: Baseline
measure: Cardiometabolic health indicators - Fat mass
timeFrame: Following 12-weeks of intervention
measure: Cardiometabolic health indicators - Waist circumference
timeFrame: Baseline
measure: Cardiometabolic health indicators - Waist circumference
timeFrame: Following 12-weeks of intervention
measure: Cardiometabolic health indicators - Menstrual status
timeFrame: Baseline
measure: Cardiometabolic health indicators - Menstrual status
timeFrame: Following 12-weeks of intervention
measure: Self-determined motivation for exercise
timeFrame: baseline
measure: Self-determined motivation for exercise
timeFrame: following 12-weeks of intervention
measure: Exercise self-efficacy
timeFrame: baseline
measure: Exercise self-efficacy
timeFrame: following 12-weeks of intervention
measure: Physical activity enjoyment
timeFrame: baseline
measure: Physical activity enjoyment
timeFrame: following 12-weeks of intervention
measure: Gender-Related Variables
timeFrame: baseline a
measure: Gender-Related Variables
timeFrame: following 12-weeks of intervention
measure: Gender identity
timeFrame: baseline
measure: Gender identity
timeFrame: following 12-weeks of intervention
Other outcomes:
measure: Focus groups
timeFrame: Following 12-weeks of intervention
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: