Validity and Reliability of Consumer-Grade Optical Heart Rate Sensors to Assess Volume of Physical Activity and to Categorize Its Intensity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Heart Rate
研究概览
简要总结
To evaluate validity and reliability of consumer-grade optical heart-rate devices we aim to compare these devices with medical-grade ECG. The design includes an extended and practical validation protocol for consumer-grade optical heart rate devices in laboratory and ambulatory free-living conditions using a medical-grade ECG device as a criterion measure.
详细描述
Candidate consumer-grade wearables are selected according to available data from manufacturers, available scientific literature and our team's own practical experience.
First, a mobile 12-lead ECG (Amedtec ECGpro, Aue, Germany) device is placed on the participant according to recommendations of medical societies and the manufacturer's instructions. Additionally, the participant wears four optical heart rate devices simultaneously. Each device will be placed according to the manufacturer's instructions, The devices will be randomly applied on the dominant or non-dominant wrist and to the dominant and non-dominant arm, respectively. All participants will be handed an instruction sheet and video how to place each device in case it is displaced and how to check that data collection is working.
The 13-min laboratory protocol will be performed in keeping with an expert statement of the INTERLIVE Network and starts with a session mimicking lifestyle activity that consists of: 1 minute of quiet sitting, 2 minutes of upper body activities, 1 minute of quiet sitting, 30 seconds of transition to treadmill, 2 minutes of walking at self-selected speed, 30 seconds of transition to chair, 2 minutes of seated typing, 30 seconds of transition, 2 minutes of full body daily living activities including vacuum cleaning and ironing, and 1 minute of quiet sitting.
After completion of the lifestyle activities test, participants proceed with the treadmill step test. The treadmill step test protocol starts with 1 minute of quiet standing, 3 minutes of (4 km/h), 30 seconds of rest, 3 minutes of running (6 km/h) and an increment of 2 km/h at each stage with 30 seconds of rest between each stage until volitional exhaustion. Capillary blood samples will be taken from the earlobe to assess blood lactate concentration after each stage of the exercise test. Dependent on physical fitness 3 to 8 blood lactate samples will be taken. A breath-by-breath spiroergometry device will measure gas exchange, ventilation and maximal oxygen uptake during the exercise test using a metabolic analyzer. After termination of the exercise test subjective exhaustion will be assessed by the BORG scale. The 12-lead ECG will allow ruling out clinically relevant coronary artery disease and/or arrhythmias, and identify maximum heart rates from which intensity zones will be derived. Test termination will be followed by a 5-min cool down period at walking speed (3 km/h) on the treadmill. Throughout the treadmill test the participant is secured with a safety belt to prevent any injuries in case of falling.
Directly after the 5-min cool down, exercise testing on the cycle ergometer starts, beginning with 1 minute of quiet sitting. Then load is increased until the participant exercises at low intensity (57-63% of maximum heart rate obtained in the treadmill test) which will be maintained for at least 2 minutes, followed by 1 minute of rest, 2 minutes of moderate intensity (64-76% of maximum heart rate), 1 minute of rest, 2 minutes of vigorous intensity (>77% of maximum heart rate) followed by 1 minute of cool-down. All activity intensity zones are defined according to medical guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 35 and 80 years
- •All sexes
- •Able to perform physical activity according to the study protocol
- •Written informed consent
排除标准
- •Acute infections and/or diseases
- •Diseases limiting walking distance and/or physical activity outlined in the study protocol
- •Atrial fibrillation
- •Clinical signs of chronic venous insufficiency ≥ 1 at upper extremities
- •Obesity WHO grade 2 or more (Body Mass Index >35 kg/m²)
- •Skin wound or tattoo where wearables are placed
- •Pregnancy
结局指标
主要结局
Heart Rate
时间窗: 24 hours
Heart rate is measured with different devices and ECG while performing different activities and free living
次要结局
未报告次要终点
研究者
Mahdi Sareban
Priv.-Doz. Dr. Dr. med.
Salzburger Landeskliniken
