UMIN-CTR Clinical Trial

Public title

Effects of KARAOKE Training for Improving Cognitive and Swallow Function in Community-Dwelling Elderly.

Acronym

Effect of KARAOKE for Improving Cognitive Function.

Scientific Title

Effects of KARAOKE Training for Improving Cognitive and Swallow Function in Community-Dwelling Elderly.

Scientific Title:Acronym

Effect of KARAOKE for Improving Cognitive Function.

Region

Japan

Condition

Dementia, Mild Cognitive Impairment, Normal elderly, Lewy body dementia, Cerebrovascular disease, Cerebral infarction, Cerebral contusion, Cerebral hemorrhage, Aftereffect of cerebral hemorrhage, Basilar artery occlusion, Cerebral arteriosclerosis, Multiple cerebral infarction, Cerebral atrophy, Vascular dementia, Chronic subdural hematoma, Parkinson's disease, Parkinsonian syndrome, Bone and joint disease, Osteoporosls, Chronic articular rheumatism, Hemiparesis, Diabetes, Disuse syndrome, Locomotive Syndrome, Sarcopenia and frailty.

Classification by specialty

Psychiatry	Oto-rhino-laryngology	Rehabilitation medicine
Dental medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to examine the beneficial effect on cognitive and swallowing function by portable karaoke training.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The screening instrument for the detection of mild cognitive impairment is compared before and after intervention for three months.

Key secondary outcomes

The evaluation of the swallowing function effect is measured with a tongue pressure gauge and a spirometer.
In addition, evaluating the motor function improvement effect is autonomic nerve function measurement, another improvement effect is to evaluate QOL and investigate the activity.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

The interventional group carries out the music session for 1-hour per week.
It is the review in which the songs practiced of the previous week and the new song practice.
The patients need to practice songs three times for 20 minutes per week at home.
A portable karaoke machine (THE KARAOKE BOOK, PDM Co., Ltd.) is given to every patient.

Interventions/Control_2

The control group carries out the scratch art for 30 min per week and completes the one artwork per week at home.
After three months, there is the program as a service session.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

65

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

No dementia.
No heart disease, no respiratory disease.
No exercised more than an hour per week.
Continue to participate in the experiment for three months.
Those families and staff who can cooperate on confirmation of exercises.
After enough explanation of the trial, those who agree with participation and give written informed consent.

Key exclusion criteria

Patients who are judged by the collaborative research investigator (psychiatrist).
Heart disease, respiratory disease.
Blind, full deafness.
No families or carers.
Regular exercise or training at least once a week.

Target sample size

60

Name of lead principal investigator

1st name	Shinichiro
Middle name
Last name	Nakamura

Organization

RIKEN

Division name

Research Cluster for Innovation, Nakamura Laboratory

Zip code

351-0198

Address

2-1 Hirosawa, Wako, Saitama 351-0198 Japan

TEL

+81(0)48-467-9477

Email

snakamura@riken.jp

Name of contact person

1st name	Atsuko
Middle name
Last name	Miyazaki

Organization

RIKEN

Division name

Research Cluster for Innovation, Nakamura Laboratory

Zip code

351-0198

Address

2-1 Hirosawa, Wako, Saitama 351-0198 Japan

TEL

+81(0)48-467-9477

Homepage URL

Email

atsuko.miyazaki.vj@riken.jp

Institute

RIKEN

Institute

Department

Personal name

Organization

PDM Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

PDM Co., Ltd.

Name of secondary funder(s)

Organization

The ethics committee of RIKEN in Wako

Address

2-1 Hirosawa, Wako, Saitama 351-0198 Japan

Tel

+81(0)48-467-9293

Email

human@riken.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

社会福祉法人 練馬区社会福祉事業団　ケアハウス（埼玉県）/ Care house of Nerima City Social Welfare Agency(Saitama)

Date of disclosure of the study information

2018

Year

02

Month

07

Day

URL releasing protocol

https://doi.org/10.3390/ijerph17041459

Publication of results

Published

URL related to results and publications

https://doi.org/10.3390/ijerph17041459

Number of participants that the trial has enrolled

26

Results

We tested whether karaoke training improves cognitive skills and reduces the risk of physical function impairments. Engaging elderly people, especially those in care homes, with karaoke training exercises that are moderately physically challenging may be a key to slowing cognitive decline and preventing dysphagia by sarcopenia.

Results date posted

2020

Year

09

Month

15

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participants were recruited from care home residents. The care homes are residential facilities for elderly people aged 65 years and older, in particular elderly people with a low income and difficulties living at home because of physical problems, their environment, or their housing circumstances. 26 participants (mean age = 82.43 years), 78.26% were women and 56.52% had more than 12 years of education. Women had an average SMI of 5.79 kg/m2 (SD = 0.84). Men exceeded the AWGS cutoff value of 7.0 kg/m2 with an average of 7.56 kg/m2 (SD = 1.34). The average MoCA score for all participants was 24.42 (SD = 4.13) and 57% of participants scored 25 points or less. Therefore, these indexes suggested participants were in the sarcopenia and MCI zones of these measures.

Participant flow

Measures of cognitive and physical function were taken before the start and after the end of the program. Participants also completed a series of cognitive and physical function tests before beginning the program schedule (Pre-test). After 12 weeks, participants were re-examined using the same neuropsychological and behavioral tests (Post-test).
Randomization into the intervention or control group was conducted after the participants provided informed consent (n = 26).
The karaoke training program ran for 1 hour, once a week for 12 consecutive weeks on weekday afternoons at the care home, and homework of 1 hour was given each week.
For the control group, Scratch art sessions were held at the care home once a week for 12 weeks on consecutive weekday afternoons and lasted half an hour. Homework was to complete one artwork per week.

Adverse events

None

Outcome measures

Cognitive Function: Montreal Cognitive Assessment (MoCA) and Frontal Assessment Battery at bedside (FAB)
Physical Function: Tongue pressure and pulmonary function
Psychological Measures: Geriatric Depression Scale (GDS) and the Life Satisfaction Index-K (LSI-K) to assess quality of life (QOL)

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2018

Year

02

Month

28

Day

Date of IRB

2018

Year

02

Month

05

Day

Anticipated trial start date

2018

Year

04

Month

01

Day

Last follow-up date

2019

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

02

Month

07

Day

Last modified on

2020

Year

09

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035602