Hemodialysis Health Management Model - the Application of Wearable Devices, Exercise and Nutritional Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Change of sit-to-stand-10 (STS-10)
研究概览
简要总结
Aim: By application of wearable devices and health management platform to strengthen physical activity and improved life quality in hemodialysis patients.
详细描述
Background: End stage renal disease (ESRD) is a global public health issue. The dialysis therapy brings huge economic burden to many countries. If patients are able to monitor their lifestyle, it not only promotes health, but also reduces the cost of health care.
Aim: By application of wearable devices and health management platform to strengthen physical activity and improved life quality in hemodialysis patients.
Material and Methods
The investigators plan to recruit 30 CKD patients as trial subjects for intervention. The intervention included wearable devices and health management platform for 24 weeks. Patients record their own diet diary by a smartphone application, and their exercise-related data are collected by wearable devices. Then, all the collected information will be upload to health management platform. The investigators compare physical and laboratory examinations before and after the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 20 years and older
- •diagnosis of ESRD receiving maintenance HD for more than 3 months
排除标准
- •inability to use a smartphone
- •impaired walking capacity
- •having a psychiatric disorder
- •any hospitalization during the previous 3 months.
- •has been changing dialysis modality or receiving renal transplantation
结局指标
主要结局
Change of sit-to-stand-10 (STS-10)
时间窗: baseline, week 4, week 8, week 12, week 16 and week 24
time to complete 10 sit-to-stand cycles
Change of sit-to-stand-60 (STS-60)
时间窗: baseline, week 4, week 8, week 12, week 16 and week 24
the number of repetitions of sit-to-stand cycles achieved in 60 seconds
Change of 6-minute walking distance (6MWT)
时间窗: baseline, week 4, week 8, week 12, week 16 and week 24
the distance the participants walk as fast as they could for 6 minutes on a flat 30-meter track
Change of hand grip strength
时间窗: baseline, week 4, week 8, week 12, week 16 and week 24
the strength of hand drip measured by a dynamometer
次要结局
- Change of KDQOL-SF(baseline, week 4, week 8, week 12, week 16 and week 24)
- Change of subjective global assessment (SGA)(baseline, week 4, week 8, week 12, week 16 and week 24)