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临床试验/NCT04137939
NCT04137939招募中不适用

Smart Health Care and Innovative Technology Service Model Plan : Development of Innovative Health Promotion System for Senior Adults

National Cheng-Kung University Hospital2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2019年7月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
400
试验地点
2
主要终点
30 second chair stand test

研究概览

简要总结

Subjects are divided into two groups, (1) Control (Ctrl) and (2) Smart Exercise (SE) group. Ctrl group are instructed to maintain their daily life. SE participants are instructed to do exercise with smart exercise system twice per week for 12 weeks. The physical fitness tests and questionnaire of both group are performed before and after the 12-week exercise program.

详细描述

The smart exercise system contain an upper extremity cycle ergometer (UEE) and a lower extremity cycle ergometer (LEE). SE group are instructed to do once session of UEE and once session of LEE per week, 30 minute per session, lasting for 12 weeks. Before each exercise, the physiological parameter are measured to ensure safety. During the exercise sessions, exercise-related metrics, including workload, cadence (revolutions per minute, RPM), exercise duration, heart rate, and facial action units (AUs), will be continuously recorded in real time. Ratings of perceived exertion will also be collected at regular intervals throughout the exercise sessions.

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
Single (Outcomes Assessor)

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Adult over 50 years old
  • •No significant limb disability or joint deformation
  • •No history of cardiovascular disease
  • •Never lost balance due to dizziness in the past 12 months

排除标准

  • •limb disability or joint deformation
  • •history of cardiovascular disease
  • •lost balance due to dizziness in the past 12 months
  • •cognitive deficits

研究组 & 干预措施

Control group

No Intervention

Ctrl group is instructed to maintain their original daily life

Smart Exercise group

Experimental

SE group are instructed to perform one session of upper extremity ergometer and one session of lower extremity ergometer in a week, 30 minute per session, lasting for 12 weeks.

干预措施: smart exercise system (Device)

结局指标

主要结局

30 second chair stand test

时间窗: after 12-week intervention

number of full stands that can be completed in 30 seconds with arms folded across chest.

30 second chair stand test

时间窗: baseline

number of full stands that can be completed in 30 seconds with arms folded across chest.

次要结局

  • Hand grip strength test(after 12-week intervention)
  • QUEST (Questionnaire for satisfaction)(after 12-week intervention)
  • SOF (Study of Osteoporotic Fractures) frailty index (Questionnaire for physical function and health status)(baseline)
  • SARC-F(baseline)
  • EQ-5D (EuroQol- 5 Dimensions)(after 12-week intervention)
  • BMI(after 12-week intervention)
  • Chair sit-&-reach test(after 12-week intervention)
  • Six-minute walk test(after 12-week intervention)
  • 2-minute step test(after 12-week intervention)
  • SMI(after 12-week intervention)
  • 8-foot up-&-go test(after 12-week intervention)
  • Back scratch(after 12-week intervention)
  • Single leg balance with eyes open test(after 12-week intervention)
  • BMI(baseline)
  • Six-minute walk test(baseline)
  • SMI(baseline)
  • Back scratch(baseline)
  • Chair sit-&-reach test(baseline)
  • 2-minute step test(baseline)
  • 8-foot up-&-go test(baseline)
  • Single leg balance with eyes open test(baseline)
  • Hand grip strength test(baseline)
  • SOF (Study of Osteoporotic Fractures) frailty index (Questionnaire for physical function and health status)(after 12-week intervention)
  • SARC-F(after 12-week intervention)
  • EQ-5D (EuroQol- 5 Dimensions)(baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Li-Chieh Kuo

Attending Physician

National Cheng-Kung University Hospital

研究点 (2)

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