Clinical trial NCT06324227: Effects of Multimodal Music Intervention on Mild Cognitive Impairment Elderly
Official title: Effects of Multimodal Music Intervention on Cognitive Function, Physical Fitness and Psychology of the Community Dwelling Elderly With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: milc cognitive impairment
cognitive function
music intervention
MMM theory
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* diagnosed with mild dementia
* not diagnosed with dementia, but are suspected cases, including chief complaint or clinical dementia rating scale 0.5.
* more than 65 years old

Exclusion Criteria:

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

Primary outcomes:
measure: Montreal Cognitive Assessment
timeFrame: about 15 minutes
measure: Saint Louis University Mental Status
timeFrame: about 15 minutes
measure: Trail Making Test
timeFrame: about 10 minutes
Secondary outcomes:
measure: 30s chair stand
timeFrame: 30 seconds
measure: back scratch test
timeFrame: 15 seconds
measure: sit and reach test
timeFrame: 15 seconds
measure: 8-foot up-and-go test
timeFrame: 15 seconds
measure: handgrip
timeFrame: 15 seconds
measure: Geriatric Depression Scale 15 items
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: NationalYangMingU
Study officials:
affiliation: National Yang Ming Chiao Tung University
name: Tzu Ting Huang, Professor
role: STUDY_CHAIR
References: