Exercise Training in Women With Cardiac Devices

Ottawa Heart Institute Research Corporation20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Cardiovascular Diseases

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Feasibility - Number of classes participants attended

Exercise attendance will be assessed by the number of classes participants attended. High attendance to the CR program will be defined as being present at ≥ 70% of the classes.

Time frame: Week 12

Feasibility - Compliance to the exercise prescription based on heart rate

Exercise compliance will be assessed as the ability to complete the prescribed intensity (based on the heart rate peak \[HR\] of the cardiopulmonary exercise test) for high-intensity interval training or moderate-intensity continuous training. The HRs across all classes for each patient will be averaged and compared to their target HR prescription. For instance, where patients exercised below, within, or above the prescribed HR ranges, these will be coded as "does not comply", "complies" and "exceeds".

Time frame: Week 12

Feasibility - Adverse events

Safety will be assessed by enumerating reported adverse events during the study period.

Time frame: Week 12

Feasibility - Number of dropouts

The number of patients who withdraw from the program will be reported as descriptive data and compared between groups (e.g., high-intensity interval program vs moderate-intensity continuous training).

Time frame: Week 12

Secondary Outcomes

Exercise capacity - maximal oxygen uptake (VO2peak)

will be measured using a gold standard symptom-limited, cardiopulmonary exercise test (CPET) on an electronically braked cycle ergometer. Gas exchange will be monitored continuously; the highest rate of oxygen uptake achieved (i.e. peak VO2 in mL/kg/min) during the last minute of the CPET will represent exercise capacity.

Time frame: Baseline

Exercise capacity - maximal oxygen uptake (VO2peak)

Time frame: Week 6

Exercise capacity - maximal oxygen uptake (VO2peak)