NCT06324227

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. 1.To build a model of multimodal music therapy.
  2. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 17, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 21, 2024

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2024

Completed
Last Updated

March 21, 2024

Status Verified

November 1, 2023

Enrollment Period

6 months

First QC Date

February 19, 2024

Last Update Submit

March 19, 2024

Conditions

Mild Cognitive Impairment

Keywords

milc cognitive impairmentcognitive functionmusic interventionMMM theory

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    about 10 minutes

Secondary Outcomes (6)

  • 30s chair stand

    30 seconds

  • back scratch test

    15 seconds

  • sit and reach test

    15 seconds

  • 8-foot up-and-go test

    15 seconds

  • handgrip

    15 seconds

  • +1 more secondary outcomes

Study Arms (2)

multimodal music therapy group

EXPERIMENTAL

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

Other: multimodal music therapy

no intervention group

EXPERIMENTAL

no intervention

Other: no intervention

Interventions

multimodal music therapyOTHER

music therapy

multimodal music therapy group
no interventionOTHER

no intervention

no intervention group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NationalYangMingU

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Tzu Ting Huang, Professor

    National Yang Ming Chiao Tung University

    STUDY CHAIR

Central Study Contacts

Tzu Ting Huang, Professor

CONTACT

02-28267016thuang@nycu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2024

First Posted

March 21, 2024

Study Start

September 17, 2023

Primary Completion

March 26, 2024

Study Completion

May 26, 2024

Last Updated

March 21, 2024

Record last verified: 2023-11

Locations

TW(1)