The Effects of Exercise Training on Physical and Mental Health in Women With Cardiac Implantable Electronic Devices (CIED-EX): a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility - Number of classes participants attended
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women (i.e., female sex assigned at birth) with CIED (≥6 months since implant)
- •Women with CIED in optimal medical therapy and functioning;
- •Patient is able to perform a symptom-limited CPET;
- •Patient is able to read and understand English or French.
排除标准
- •Patient is currently participating in routine exercise training (>2x/week);
- •Patient has: documented unstable angina; or established diagnosis of chronic obstructive pulmonary disease, severe mitral or aortic stenosis, or hypertrophic obstructive cardiomyopathy;
- •Patient has an unmanaged psychiatric illness (e.g., active psychosis, suicidal ideation) or cognitive impairment;
- •Patient does not have an internet connection or a device with a camera and speakers;
- •Patient with any device troubleshooting at resting or during exercise;
- •Patient is unable to provide written informed consent;
- •Patient is unwilling or unable to return for follow-up visits at week 12;
- •Patient is unwilling to be randomized to HIIT or MICT; or
- •Pregnancy or patients who become pregnant during the 12-week intervention phase (the effects of interval training on an unborn fetus are unknown).
研究组 & 干预措施
Standard care + moderate-intensity continuous exercise training (MICT)
Supervised virtual MICT exercise sessions for 12 weeks (2x/wk) using the platform Zoom Care.
干预措施: moderate-intensity continuous exercise training (MICT) group (Behavioral)
Standard care + high-intensity interval training (HIIT)
Supervised virtual HIIT exercise sessions for 12 weeks (2x/wk) using the platform Zoom Care.
干预措施: high-intensity interval training (HIIT) group (Behavioral)
结局指标
主要结局
Feasibility - Number of classes participants attended
时间窗: Week 12
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.
Feasibility - Compliance to the exercise prescription based on heart rate
时间窗: Week 12
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".
Feasibility - Adverse events
时间窗: Week 12
Safety will be assessed by enumerating reported adverse events during the study period.
Feasibility - Number of dropouts
时间窗: Week 12
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).
次要结局
- Exercise capacity - maximal oxygen uptake (VO2peak)(Following 12-weeks of intervention)
- Cardiometabolic health indicators - Menstrual status(Following 12-weeks of intervention)
- Physical activity enjoyment(following 12-weeks of intervention)
- Cardiometabolic health indicators - Blood pressure(Following 12-weeks of intervention)
- Cardiometabolic health indicators - Body mass index(Following 12-weeks of intervention)
- Cardiometabolic health indicators - Fat mass(Following 12-weeks of intervention)
- Gender identity(following 12-weeks of intervention)
- Mental health - Anxiety levels(Following 12-weeks of intervention)
- Cardiometabolic health indicators - Heart rate(Following 12-weeks of intervention)
- Cardiometabolic health indicators - Waist circumference(Following 12-weeks of intervention)
- Quality of life (self-reported)(Following 12-weeks of intervention)
- Mental health - Depression levels(Following 12-weeks of intervention)
- Self-determined motivation for exercise(following 12-weeks of intervention)
- Gender-Related Variables(following 12-weeks of intervention)
- Exercise self-efficacy(following 12-weeks of intervention)
- Exercise capacity - maximal oxygen uptake (VO2peak)(Baseline)
- Exercise capacity - maximal oxygen uptake (VO2peak)(Week 6)
- Quality of life (self-reported)(Baseline)
- Cardiometabolic health indicators - Waist circumference(Baseline)
- Cardiometabolic health indicators - Fat mass(Baseline)
- Cardiometabolic health indicators - Menstrual status(Baseline)
- Mental health - Anxiety levels(Baseline)
- Mental health - Depression levels(Baseline and following 12-weeks of intervention)
- Cardiometabolic health indicators - Blood pressure(Baseline)
- Cardiometabolic health indicators - Heart rate(Baseline)
- Cardiometabolic health indicators - Body mass index(Baseline)
- Self-determined motivation for exercise(baseline)
- Exercise self-efficacy(baseline)
- Physical activity enjoyment(baseline)
- Gender-Related Variables(baseline a)
- Gender identity(baseline)