Mild Cognitive ImpairmentNCT06324227
Effects of Multimodal Music Intervention on Mild Cognitive Impairment Elderly
A study testing multimodal music therapy in people with Mild Cognitive Impairment, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- multimodal music therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Sep 2023to 26 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- having severe hearing impairment, or can not talk with Chinese or Taiwanese
- having exercise contraindication
- diagnosed with other psychiatric disorders
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
NationalYangMingU
Taipei
Wei Zu Lo, 02-2823-9753 ext. 66378, weitzu@nycu.edu.tw
About this study
Official title: Effects of Multimodal Music Intervention on Cognitive Function, Physical Fitness and Psychology of the Community Dwelling Elderly With Mild Cognitive Impairment
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:
- To build a model of multimodal music therapy.
- 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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- multimodal music therapy, no intervention
- Keywords
- milc cognitive impairment, cognitive function, music intervention, MMM theory
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multimodal music therapyOther
music therapy
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| multimodal music therapy group | Experimental | using twice a week, 12 weeks music intervention with singing and physical movement with rhythm Receives: Other: multimodal music therapy |
| no intervention group | Experimental | no intervention Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment
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.
Measured: about 15 minutes
Saint Louis University Mental Status
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.
Measured: about 15 minutes
Trail Making Test
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.
Measured: about 10 minutes
Secondary outcomes (6)
30s chair stand
stand up and sit down in 30 seconds to calculate how many times
Measured: 30 seconds
back scratch test
two hands need to reach in your back, one hand on upper and another on lower position
Measured: 15 seconds
sit and reach test
sit on the floor with legs stretched out straight. Then reach forward as far as possible with hands
Measured: 15 seconds
8-foot up-and-go test
calculate the time the participant walk a round trip in a line with 2.44 meters
Measured: 15 seconds
handgrip
participants hold handgrip dynamometer in each hand and squeeze the device as hard as they could to calculate how many kilograms
Measured: 15 seconds
Geriatric Depression Scale 15 items
This 15-question assessment scale is mainly used to detect the tendency of depression in the elderly. Answer "yes" or "no" by reading the questions and comparing their own psychological status. The total score is 0-15. Score 0-4 indicates no tendency to be depressed, 5-10 indicates a tendency to be depressed, and 10-15 indicates a tendency to be severely depressed. The higher the score, the higher the tendency of depression.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start17 Sep 2023
- Primary completion26 Mar 2024 (estimated)
- Study completion26 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tzu Ting Huang, Professor, Study chair, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324227
- Sponsor's protocol ID
- 311203003
- Status last verified
- Nov 2023
- First submitted
- 19 Feb 2024
- Last updated
- 21 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Multimodal Music Intervention on Cognitive Function, Physical Fitness and Psychology of the Community Dwelling Elderly With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT06324227
- Acronym / sponsor ID
- 311203003
- Conditions
- Mild Cognitive Impairment
- Keywords
- milc cognitive impairment, cognitive function, music intervention, MMM theory
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 17 Sep 2023 (actual)
- Primary completion
- 26 Mar 2024 (estimated)
- Study completion
- 26 May 2024 (estimated)
- First posted
- 21 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To build a model of multimodal music therapy.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| multimodal music therapy group | Experimental | Other: multimodal music therapyusing twice a week, 12 weeks music intervention with singing and physical movement with rhythm |
| no intervention group | Experimental | Other: no interventionno intervention |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- having severe hearing impairment, or can not talk with Chinese or Taiwanese
- having exercise contraindication
- diagnosed with other psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multimodal music therapymusic therapy | Other | multimodal music therapy group |
| no interventionno intervention | Other | no intervention group |
Primary outcome
Montreal Cognitive Assessment
Time frame: 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.
Saint Louis University Mental Status
Time frame: 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
Time frame: 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.
6 secondary outcomes
30s chair stand
Time frame: 30 seconds
back scratch test
Time frame: 15 seconds
sit and reach test
Time frame: 15 seconds
8-foot up-and-go test
Time frame: 15 seconds
handgrip
Time frame: 15 seconds
Geriatric Depression Scale 15 items
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tzu Ting Huang, Professor study chair
National Yang Ming Chiao Tung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multimodal music therapy in people with Mild Cognitive Impairment, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tzu Ting Huang, Professor (02-28267016 ext. 65323, thuang@nycu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment (time frame: about 15 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.