The Effect of Feedback on Physical Activity Surveillance Using Wearable Device-Smartphone Application for Resolution of Metabolic Syndrome in Aged 60 or Older ; a 12-Week Randomized Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Measurement of physical activity through wearable devices
研究概览
简要总结
The Effect of Feedback on Physical Activity Surveillance using Wearable Device-Smartphone Application for Resolution of Metabolic Syndrome in Aged 60 or older; a 12-Week Randomized Control Study
详细描述
Research on whether wearable device interventions can effectively prevent metabolic syndrome remains insufficient. This study aimed to evaluate the effect of feedback on clinical indicators in patients with metabolic syndrome aged 60 or older on activities measured using wearable devices, such as smartphone apps. Patients aged 60 or older diagnosed with metabolic syndrome were recruited and prescribed to survive for 12 weeks using wrist-worn devices (B.BAND, B Life Inc, Korea). The block randomization method was used to distribute the participants between an intervention group (n=20) and control group (n=20). In the intervention group, an experienced study coordinator provided feedback on physical activity to individuals through telephone counseling every other week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed with metabolic syndrome by a doctor.
- •Aged 60 or older.
- •A person who understands the clinical trial process and signs the consent form
- •Possession of a smartphone and a daily mobile phone user for the past
- •months and expected to use for more than 3 months.
- •A person who agrees to provide the data on the amount of physical activity measured and collected by a wearable device.
- •A person who can exercise at an intensity more than walking for 12 weeks.
排除标准
- •Under the aged
- •A person who does not agree to provide data on physical activity.
- •Those who who are judged to have difficulty in exercising such as walking due to uncontrolled diabetes, high blood pressure or serious cardiovascular disease.
- •A person who is not used to or is reluctant to use a smartphone app.
- •Those who have difficulty wearing wearable devices due to skin diseases around their wrists.
- •A person who is expected to have an unintended change in weight over the next three months due to current pregnancy and planning, thyroid disease, cancer, etc.
结局指标
主要结局
Measurement of physical activity through wearable devices
时间窗: For 12 weeks
Investigators provided with wrist-wearable device (B.BAND, B Life Inc, Korea), which allowed them to wear and live for 12 weeks. Researchers who have been granted access can check and track participants' physical activity on a daily basis through a web page.
Changes in waist circumference (cm) at baseline and 12th week visits
时间窗: Baseline and 12th week
The waist circumference was evaluated by a trained examiner (after normal exhalation) to the nearest millimeter from the midpoint between the lower edge of the rib and the iliac ridge.
Changes in blood pressure (systolic blood pressure, diastolic blood pressure) at baseline and 12th week visits
时间窗: Baseline and 12th week
Blood pressure was measured in a sitting position after resting using BP-203 RVII(Colin Corp, Aichi, Japan).
Changes in fasting blood tests at baseline and 12th week visits
时间窗: Baseline and 12th week
Blood samples were collected from the Jeonju vein after fasting for 6 hours and analyzed in our hospital's laboratory. The lipid profile was tested using an automated analyzer (Hitachi 747, Hitachi Corp, Japan) and enzyme colorimetric method.
次要结局
- Depression index at baseline and 12th week visits(Baseline and 12th week)
- Pulse wave velocity measurement on baseline and 12th week visits(Baseline and 12th week)
- Changes in height at baseline and 12th week visits(Baseline and 12th week)
- Changes in body composition at baseline and 12th week visits(Baseline and 12th week)
- Changes in body weight at baseline and 12th week visits(Baseline and 12th week)
- Stress scale questionnaires at baseline and 12th week visits(Baseline and 12th week)
研究者
Young Jin Tak
Principal Investigator
Pusan National University Hospital