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临床试验/NCT04770558
NCT04770558Unknown不适用

Effectiveness of Interactive Exergame to Improve Physical and Cognitive Functions in Older Adults With Sarcopenia

Taipei Medical University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年3月9日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Function ability

研究概览

简要总结

Sarcopenia has been defined as an age related, involuntary loss of skeletal muscle mass and strength. The prevalence of sarcopenia is about 10% globally, and risk factors of sarcopenia includes age, lower physical activity, and malnutrition. Sarcopenia can lead to many adverse health outcomes, particularly in physical and cognitive functions. Most of previous studies have reported that interactive exergame can improve cognitive and physical functions in older population but none of studies use of interactive exergame on older adults with sarcopenia. Therefore, the aim of study will investigate the effects of interactive exergame on older adults with sarcopenia.

详细描述

A total of 60 older participants will be randomly assigned to the experimental and control groups. Participants in the experimental group will receive 40 minutes per session, 2 times a week for 12 weeks interactive exergame while those in the control group will maintain their regular activity. All participants will be assessed their physical and cognitive function, sarcopenia index and other health related outcome measurements before and after intervention program.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
65 Years 至 99 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 65-99 years old
  • able to walk 6 meters without assistance devices
  • older adults with possible sarcopenia, sarcopenia or severe sarcopenia

排除标准

  • people with hemodialysis
  • people with built-in electronic medical equipment
  • people with central nervous system disease such as stroke or Parkinson's disease
  • score in ascertain dementia 8 more than 2
  • people with mental illness

结局指标

主要结局

Function ability

时间窗: Change from Baseline function ability at Week 12

Function ability test will be determined by the timed up and go test (TUG). Participants will be asked to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. The times(s) to complete the task will be recorded. Higher than 12s indicate weakness in function ability.

Cognitive function

时间窗: Change from Baseline cognitive function at Week 12

Cognitive function will be evaluated by the Montreal Cognitive Assessment (MoCA), which includes visuospatial abilities, short-term memory recall task, multiple aspects of executive functions, attention, concentration, and working memory. The total score is 30 and the score less than 26 indicates mild cognitive impairment.

Lower limbs strength

时间窗: Change from Baseline lower limbs strength at Week 12

Lower limbs strength will be assessed by the Five Times Sit to Stand. Participants will be asked to sit on the chair with arms folded across their chest, and stand up and sit down as quickly as possible for 5 times. The time (s) to complete the task will be recorded.The time more than 12 seconds indicates weakness in lower limbs strength.

Appendicular muscle mass

时间窗: Change from Baseline appendicular muscle mass at Week 12

Appendicular muscle mass will be assessed by the Body Impedance Analysis (BIA).Participants will be asked to stand on the machine and hold the handle of the machine. Female less than 5.7kg/m2 and male less than 7 kg/m2 indicate lower muscle mass.

Hand grip

时间窗: Change from Baseline hand grip at Week 12

Dominant hand grip (kg) will measured by a dynamometer. Participants will stand with their arms down by their sides. They will squeeze the dynamometer with maximum isometric effort, which is maintained for 6 seconds. Female less than 18 kg and man less than 28 kg indicate weakness in grip strength.

Fear of falling

时间窗: Change from Baseline fear of falling at Week 12

Fear of falling will be measured by the Falls Efficacy Scale- International (FES-I). The FES-I rates each daily task from "no confident at all" to "completely confident". The total score is between 16 and 64, and the score more than 28 indicates higher level of fear of falling.

Static balance

时间窗: Change from Baseline static balance at Week 12

Static balance test will be assessed by the modified Clinical Test for Sensory Interaction in Balance(mCTSIB), The mCTSIB was developed as a clinical version of the Sensory Organization Test and was developed to assesses sensory contributions to postural control. Participants will stand with their hands at their sides, feet together and perform the following 4 sensory conditions: (1) Stand on firm surface with eyes open (2) Stand on firm surface with eyes closed (3) Stand on foam surface with eyes open (4) Stand on foam surface with eyes closed. Each condition will be timed for maximum 30 seconds. The test is terminated when a participant's arms or feet moves. If participants are unable to maintain the position for 30 seconds, they are then provided with 2 additional attempts. The time (s) to complete each condition will be recorded.If they can't complete this test indicate weakness in static balance

Walking ability

时间窗: Change from Baseline walking ability at Week 12

Walking ability test will be measured by the 6 meter walk test. Participant will be asked to walk at their self-selected speed. The time for the middle 6 meters will be recorded and walking speed (m/s) will be calculated.

次要结局

  • Physical Activity(Change from Baseline physical activity at Week 12)
  • Health-related quality of life(Change from Baseline health-related quality of life at Week 12)
  • Depression(Change from Baseline depression at Week 12)
  • Diet record(Change from Baseline diet record at Week 12)

研究者

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

Shu-Chun Lee

Assistant Professor

Taipei Medical University

研究点 (1)

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