An Evaluation of the Talk Test as an Effective and Safe Approach for Exercise Prescription for Home-Based Cardiac Rehabilitation: A Pilot RCT
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Exercise capacity
研究概览
简要总结
The objectives of this pilot RCT are to examine if the Talk Test is an effective and safe tool as compared with CPET for exercise prescription in patients who have undergone CABG or PCI and enrolled in a home-based CR program with virtual exercise training monitoring.
详细描述
The Talk Test has been shown to be a valid, practical and inexpensive tool for guiding exercise training in patients with CAD. The general premise of the Talk Test is that exercising at or above the ventilatory threshold or lactate threshold does not allow comfortable, conversational speech and thus serves as a means of estimating the cut point between moderate and vigorous intensity exercise. The Talk Test can be used to produce exercise intensities (64 to 95% HR peak i.e. moderate-to-vigorous intensity exercise) within accepted Canadian Association of Cardiovascular Prevention and Rehabilitation (CACPR) guidelines for exercise training, to avoid exertional ischemia, and has been shown to be consistent across various modes of exercise (i.e. walking, jogging, cycling, elliptical trainer and stair stepper).
There is a critical need to evaluate the effectiveness and safety of using the Talk Test as the principal method of exercise prescription in patients with CAD who have undergone CABG or PCI when compared to standard care CPET. Such a trial has wide-scale appeal for CR programs across Canada and beyond. It will directly and positively impact patient care by reducing the need for in-person interactions for CPET, of paramount importance during COVID-19 outbreaks, between patients and CR staff, thus reducing COVID-19 infection risk and concerns of contracting the virus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •recently underwent PCI or CABG (at least 4 weeks but less than 12 weeks post-event or procedure);
- •able to perform a CPET;
- •at least 40 years of age;
- •access to MyChart; and,
- •access to email and the internet
- •access to a cellphone with broadband internet (4G, LTE, 5G).
排除标准
- •currently participating in a virtual or on-site CR program;
- •ventricular ejection fraction ≤45%;
- •unstable angina or established diagnosis of chronic obstructive pulmonary disease, severe mitral or aortic stenosis, or hypertrophic obstructive cardiomyopathy;
- •unable to return for 12-week follow-up visits.
研究组 & 干预措施
Talk Test
Virtual Cardiac Rehab + Exercise prescription based on the Talk test.
干预措施: Talk test prescription (Behavioral)
Cardiopulmonary Exercise Test
Virtual Cardiac Rehab + Exercise prescription based on the CPET results.
干预措施: CPET prescription (Behavioral)
结局指标
主要结局
Exercise capacity
时间窗: from baseline to follow-up at week 12
will be measured by the Incremental Shuttle Walk Test.
次要结局
- Cardiovascular health indicators - Plasma glucose average(from baseline to follow-up at week 12)
- Cardiovascular health indicators - Cholesterol LDL(from baseline to follow-up at week 12)
- Cardiovascular health indicators - Cholesterol HDL(from baseline to follow-up at week 12)
- Cardiovascular health indicators - Plasma glucose(from baseline to follow-up at week 12)
- Cardiovascular health indicators - Lipid profile(from baseline to follow-up at week 12)
- Cardiac Rehab safety(from baseline to follow-up at week 12)
- VO2peak(at baseline)