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临床试验/NCT06324227
NCT06324227Unknown不适用

Effects of Multimodal Music Intervention on Cognitive Function, Physical Fitness and Psychology of the Community Dwelling Elderly With Mild Cognitive Impairment

National Yang Ming Chiao Tung University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年9月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Saint Louis University Mental Status

研究概览

简要总结

The goal of this clinical trial is to learn about whether music therapy can ameliorate cognitive function, physical fitness and psychology in mild cognitive impairment and mild dementia population. The main questions it aims to answer are:

  1. To build a model of multimodal music therapy.
  2. To discuss the effect of twelve-week multimodal music therapy in ameliorating community-based elders with MCI and mild dementia. Main outcome variables: cognitive function (Montreal Cognitive Assessment Scale, trail making test, Saint Louis University Mental Status Examination). Secondary outcome variables: physical fitness (muscle strength, muscular endurance, flexibility, balance ability), depression.

详细描述

The prevalence of the elderly with mild cognitive impairment accounts for one-fifth of the elderly population in Taiwan, and there is no medication that can effectively treat the disease. According to the literature review, there are many factors that cognitive impairment would influence. Many chronic diseases can induce cognitive decline, and depression is also related to cognitive function, including memory loss and cognitive decline. Mild cognitive impairment or dementia are also related to disability. Therefore, we choose the music, mood and movement(MMM) theory to connect psychology, cognitive function and physical fitness. The purpose of the research is to establish a model of the multimodal music therapy model and explore the effect of the multimodal music therapy on improving the mild cognitive impairment and mild dementia in the community. The senior with mild cognitive impairment and mild dementia are divided into an experimental group and a control group through randomization consisted of total 49 people based on different day care centers or community-based dementia care centers. It will take 12 weeks for the intervention. The experimental group received multimodal music intervention twice a week, each time with a duration of 70 minutes. The design method partly refers to the methods designed by Shimizu, including three musical instruments for the music therapy and physical activity, and the control group does not have any intervention. The experimental group and the control group have two weeks of pre-test and post-test, and the information sheet of demography, Montreal Cognitive Assessment, Saint Louis University Mental Status Exam, Trail Making Test, muscle strength and endurance, flexibility and dynamic balance ability, Geriatric Depression Scale would be collected before and after the 12-week intervention. The research data is analyzed with Statistical Product and Service Solutions(SPSS). We expect cognitive function, physical fitness and psychology can be improved through multimodal music therapy. This study is also the first time using music, mood and movement theory and applied to multimodal music therapy in Taiwan. If the research results are beneficial, this theory would become a beneficial choice for the elderly with cognitive decline.

研究设计

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

入排标准

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

入选标准

  • •diagnosed with mild dementia
  • •not diagnosed with dementia, but are suspected cases, including chief complaint or clinical dementia rating scale 0.
  • •more than 65 years old

排除标准

  • •having severe hearing impairment, or can not talk with Chinese or Taiwanese
  • •having exercise contraindication
  • •diagnosed with other psychiatric disorders

研究组 & 干预措施

multimodal music therapy group

Experimental

using twice a week, 12 weeks music intervention with singing and physical movement with rhythm

干预措施: multimodal music therapy (Other)

no intervention group

Experimental

no intervention

干预措施: no intervention (Other)

结局指标

主要结局

Saint Louis University Mental Status

时间窗: about 15 minutes

The Saint Louis University Mental Status(SLUMS) scale includes five major cognitive function: orientation, memory, attention, executive function and language ability. There are 11 questions with a total score of 30 points. The minimum score is 0 and the highest score is 30. There are total score of 30 points. The lower points means the more severe the cognitive function is.

Trail Making Test

时间窗: about 10 minutes

The test is designed to examine the attention and can be divided into two parts. There are number 1-25 in circles that appear randomly on the paper. There are Chinese Zodiac and twelve numbers in Trail Making Test-B.

Montreal Cognitive Assessment

时间窗: about 15 minutes

The Montreal Cognitive Assessment scale(MoCA) has seven major cognitive functions, including short-term memory, visuospatial, executive function, language ability, attention, abstract reasoning, and orientation. The minimum score is 0 and the highest score is 30. There are total score of 30 points. Considering the literacy, the lower points means the more severe the cognitive function is.

次要结局

  • 8-foot up-and-go test(15 seconds)
  • sit and reach test(15 seconds)
  • 30s chair stand(30 seconds)
  • handgrip(15 seconds)
  • back scratch test(15 seconds)
  • Geriatric Depression Scale 15 items(10 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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