UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000031189
Receipt No. R000035602
Scientific Title Effects of KARAOKE Training for Improving Cognitive and Swallow Function in Community-Dwelling Elderly.
Date of disclosure of the study information 2018/02/07
Last modified on 2020/09/15 (Ver. 5)

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Basic information
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
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

Objectives
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

Assessment
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.

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute RIKEN
Institute
Department

Funding Source
Organization PDM Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor PDM Co., Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
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
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
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)

Other administrative information
Date of disclosure of the study information
2018 Year 02 Month 07 Day

Related information
URL releasing protocol https://doi.org/10.3390/ijerph17041459
Publication of results Published

Result
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

Progress
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
Other related information

Management information
Registered date
2018 Year 02 Month 07 Day
Last modified on
2020 Year 09 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035602