A Pilot Study to Evaluate the Use of a Wrist-worn Accelerometer Device for Physical Activity Monitoring in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Number of Participants that Wear Watch as Instructed
研究概览
简要总结
In this study, researchers want to learn if a watch can be used to track physical activity in healthy people. The watch will collect the data and send it to a database using a data storage device.
The goal of this study is to measure:
- The number of people who wear the watch as instructed
- The number of working watches and data storage devices returned at the end of the study
- The number of watches that successfully sent data back to a database
- The overall daily activity for people including the number of daily steps taken and how much time is spent doing non-exercise activity and mild to intense exercise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The key inclusion criteria include but are not limited to:
- •Is in good health
- •Is willing to comply with study restrictions
排除标准
- •The key exclusion criteria include but are not limited to:
- •History of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- •History of cancer
研究组 & 干预措施
Watch Wearing to Track Activity
Participants wear a watch that tracks physical activity throughout study.
干预措施: Activity Tracking Watch (Device)
结局指标
主要结局
Number of Participants that Wear Watch as Instructed
时间窗: Up to approximately 2 weeks
The number of participants that wear the watch for at least 19.2 hours per day (80% of the time) will be reported.
Number of Provisioned Watches and Data Storage Devices That Were Returned
时间窗: Up to approximately 2 weeks
The number of watches and data storage devices provisioned and returned free from malfunction will be reported.
Number of Watches and Data Storage Devices that Successfully Transmit Data
时间窗: Up to approximately 2 weeks
The number of watches and data storage devices that successfully transmit data to central database will be reported.
Average Daily Overall Activity Count
时间窗: Up to approximately 2 weeks
The average daily overall activity will be reported.
Average Daily Total Step Count
时间窗: Up to approximately 2 weeks
The number of average daily total steps will be reported.
Average Daily Time (minutes) in Nonsedentary Activity
时间窗: Up to approximately 2 weeks
The average daily time spent in nonsedentary activity will be reported.
Average Daily Time (minutes) in Moderate-to-Vigorous Physical Activity
时间窗: Up to approximately 2 weeks
The average daily time spent in moderate-to-vigorous physical activity will be reported.
次要结局
- Number of Participants Who Experience an Adverse Event (AE)(Up to approximately 2 weeks)
- Number of Participants Who Discontinue Study Intervention Due to an AE(Up to approximately 2 weeks)