Effects of Multimodal Music Intervention on Mild Cognitive Impairment Elderly

March 19, 2024 updated by: National Yang Ming University

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:

  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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Tzu Ting Huang, Professor
  • Phone Number: 65323 02-28267016
  • Email: thuang@nycu.edu.tw

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • NationalYangMingU
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: multimodal music therapy group
using twice a week, 12 weeks music intervention with singing and physical movement with rhythm
Other: multimodal music therapy
music therapy
Experimental: no intervention group
no intervention
Other: no intervention
no intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
about 15 minutes
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.
about 15 minutes
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.
about 10 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
30s chair stand
Time Frame: 30 seconds
stand up and sit down in 30 seconds to calculate how many times
30 seconds
back scratch test
Time Frame: 15 seconds
two hands need to reach in your back, one hand on upper and another on lower position
15 seconds
sit and reach test
Time Frame: 15 seconds
sit on the floor with legs stretched out straight. Then reach forward as far as possible with hands
15 seconds
8-foot up-and-go test
Time Frame: 15 seconds
calculate the time the participant walk a round trip in a line with 2.44 meters
15 seconds
handgrip
Time Frame: 15 seconds
participants hold handgrip dynamometer in each hand and squeeze the device as hard as they could to calculate how many kilograms
15 seconds
Geriatric Depression Scale 15 items
Time Frame: 10 minutes
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.
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Yang Ming University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Tzu Ting Huang, Professor, National Yang Ming University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 17, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 26, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 26, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 21, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 311203003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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