UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061934 |
|---|---|
| Receipt number | R000070834 |
| Scientific Title | Effects of a Home-Based Dual-Task Intervention Incorporating Cognitive Stimulation into Daily Activities in Older Adults with Subjective Memory Complaints: A Pilot Quasi-Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/06/17 |
| Last modified on | 2026/06/16 22:55:40 |
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Basic information
Public title
Home-Based Dual-Task Intervention with Cognitive Stimulation Integrated into Daily Activities for Improving Subjective Memory Complaints: A Pilot Study
Acronym
SMC-DT Study
Scientific Title
Effects of a Home-Based Dual-Task Intervention Incorporating Cognitive Stimulation into Daily Activities in Older Adults with Subjective Memory Complaints: A Pilot Quasi-Randomized Controlled Trial
Scientific Title:Acronym
HOME-DT Study
Region
| Japan |
Condition
Condition
Community-dwelling older adults with subjective memory complaints
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of a home-based intervention incorporating cognitive stimulation into daily activities in improving subjective memory complaints among community-dwelling older adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in subjective memory complaints and hippocampal volume.
Key secondary outcomes
Logical Memory I and II scores of the Wechsler Memory Scale
Mini-Cog
Japanese version of the WHOQOL-OLD
Life Satisfaction Index-Z (LSI-Z)
Geriatric Depression Scale-15 (GDS-15)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants will perform a home-based dual-task intervention incorporating cognitive stimulation into personally meaningful daily activities for six months. Up to five important daily activities will be identified based on the Canadian Occupational Performance Measure, and participants will select cognitive tasks, such as word-chain games, calculation, recall, and memory exercises, to be combined with these activities. Participants will be encouraged to perform the dual tasks three to four times per week for approximately 10 minutes per session. They will record the frequency of cognitive task performance and their impressions in a diary. Participants will be instructed not to perform the tasks when experiencing pain or fatigue.
Interventions/Control_2
Participants in the control group will continue their usual daily lives for six months. After the 6-month study period, participants assigned to the control group will be offered the opportunity to receive the same dual-task program incorporating cognitive stimulation into personally meaningful daily activities, if desired.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Community-dwelling older adults aged 65 years or older who are not certified as requiring long-term care, have not been diagnosed with dementia, and are able to communicate effectively.
Key exclusion criteria
Individuals who have been advised by their physician not to engage in exercise. In addition, exclusion criteria for MRI scanning will be assessed according to the guidelines of the Japan Medical Imaging and Radiological Systems Industries Association (JIRA), and individuals with any possibility of having metallic implants or metal objects in the body will be excluded.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Katsushi |
| Middle name | |
| Last name | Yokoi |
Organization
Osaka Metropolitan University
Division name
Graduate School of Rehabilitation Science
Zip code
536-8525
Address
2-1-132 Morinomiya, Joto-ku, Osaka 536-8525, Japan
TEL
0661671264
yokoikat@omu.ac.jp
Public contact
Name of contact person
| 1st name | Katsushi |
| Middle name | |
| Last name | Yokoi |
Organization
Osaka Metropolitan University
Division name
Graduate School of Rehabilitation Science
Zip code
536-8525
Address
2-1-132 Morinomiya, Joto-ku, Osaka 536-8525, Japan
TEL
0661671264
Homepage URL
yokoikat@omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Osaka Metropolitan University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Rehabilitation Science, Osaka Metropolitan University
Address
2-1-132 Morinomiya, Joto-ku, Osaka 536-8525, Japan
Tel
0661671264
yokoikat@omu.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
大阪公立大学および森ノ宮医療大学
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 06 | Month | 16 | Day |
Last modified on
| 2026 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070834
