UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057494 |
|---|---|
| Receipt number | R000065695 |
| Scientific Title | Design and Evaluation of a Neurofeedback-Based Program for Preventive Elderly Care |
| Date of disclosure of the study information | 2025/04/02 |
| Last modified on | 2025/04/02 20:22:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Design and Evaluation of a Neurofeedback-Based Program for Preventive Elderly Care
Acronym
Design and Evaluation of a Neurofeedback-Based Program for Preventive Elderly Care
Scientific Title
Design and Evaluation of a Neurofeedback-Based Program for Preventive Elderly Care
Scientific Title:Acronym
Design and Evaluation of a Neurofeedback-Based Program for Preventive Elderly Care
Region
| Japan | Asia(except Japan) |
Condition
Condition
Preventing Cognitive Decline
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to develop and evaluate effective dementia prevention interventions suitable for rural areas in Thailand and Japan, where infrastructure and human resources are limited.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to detect and make visible early signs of cognitive decline in older adults by measuring prefrontal cerebral blood flow with near-infrared spectroscopy (NIRS) during dual-task activities.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Basic Attributes
Household situation, chief complaint, medical history, presence or absence of a primary care physician, and family history.
Cognitive Function
Assessment by an Occupational Therapist using the following tools.
MoCA: Montreal Cognitive Assessment. Covers visuospatial and executive function, naming, memory, attention, repetition, language fluency, abstraction, delayed recall, and orientation.
MMSE: Mini-Mental State Examination. Consists of 11 items with a maximum score of 30, assessing orientation, memory, calculation, language ability, and visuospatial skills.
Physical Function
Body composition, muscle strength: grip strength, balance: one-leg standing with eyes open, 4-meter walking speed, dexterity and agility: Timed Up & Go test, and blood component analysis including calcium, blood glucose: BS, HbA1c, lipids: TG, total cholesterol, HDL cholesterol, LDL cholesterol, and 25-hydroxyvitamin D: 25OHD.
Self-Reported Measures
Health behaviors, nutrition, mental and psychological well-being, quality of life: WHO-QOL26, short form of the Geriatric Depression Scale: GDS, and food frequency questionnaire: FFQ.
Brain Blood Flow Imaging
Measurement using Near-Infrared Spectroscopy: NIRS to assess cerebral blood flow.
The above items will be measured before and after a 60-minute intervention program conducted once a week for three months, and the changes observed will be used as outcome evaluations.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention Program
The intervention method is based on the Manual for Preventive Care Revised Edition issued by the Ministry of Health, Labour and Welfare, Chapter 3: Program for Improving Locomotive Function, Program Content, Standard Program. Referring to this, the researchers and a certified health exercise instructor jointly developed the MMT Program using Music and Naruko, Shimizu et al., 2017, which was used as a reference to create and implement the ECP, Exercise Care Program.
The ECP instructor will provide guidance online.
Participants will be divided into two groups: one group, intervention group, receives neurofeedback while using a 2-channel NIRS device, and the other group, control group, receives only the ECP program.
Both the intervention and control groups will participate in the program once a week for 12 weeks, approximately one hour per session.
Online Instruction
The exercise instructor will be connected online with the venue, and participants will receive group instruction from the ECP instructor projected on a screen. At the same time, on-site staff will be present to check participants' movements and ensure their understanding.
Participants in both the intervention and control groups will gather at the designated venues, undergo a health check by healthcare professionals, and then begin the program.
The allocation to either the intervention or control group will be determined by local government staff, based on the venue where each participant has applied to join.
Interventions/Control_2
Group with no intervention, and group with only pre- and post-intervention assessments.
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
| 60 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Age: 65 to 90 years old (60 to 90 years old in Thailand)
Inclusion Criteria*: Healthy older adults (residing near the participating municipalities) who are able to attend the sessions continuously.
Key exclusion criteria
Individuals who fall under any of the following conditions1-9:
1 Those who have experienced loss of consciousness or dizziness leading to loss of balance, and have not fully recovered.
2 Those with malignant tumors or heart disease.
3 Those with severe hypertension.
4 Those using implantable electronic devices such as pacemakers.
5 Those who require bed rest or are in significantly poor physical condition.
6 Those experiencing symptoms such as dizziness, unsteadiness, or whole-body tremors.
7 Those with deep vein thrombosis.
8 Those who have been advised by a physician not to engage in physical activity.
9 Those who feel any other physical abnormalities not listed above.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Nobuko |
| Middle name | |
| Last name | Shimizu |
Organization
Toyama Prefectural University
Division name
Faculty of Nursing
Zip code
930-0975
Address
2-2-78 Nishinagakoe, Toyama City, Toyama Prefecture, Japan
TEL
076-464-5410
n-shimizu@pu-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Nobuko |
| Middle name | |
| Last name | Shimizu |
Organization
Toyama Prefectural University
Division name
Faculty of Nursing
Zip code
930-0975
Address
2-2-78 Nishinagakoe, Toyama City, Toyama Prefecture, Japan
TEL
076-464-5410
Homepage URL
n-shimizu@pu-toyama.ac.jp
Sponsor or person
Institute
Toyama Prefectural University
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toyama Prefectural University
Address
2-2-78 Nishinagakoe, Toyama City, Toyama Prefecture, Japan
Tel
076-464-5410
n-shimizu@pu-toyama.ac.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2017 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 04 | Month | 02 | Day |
Last modified on
| 2025 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065695
