UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060209 |
|---|---|
| Receipt number | R000068863 |
| Scientific Title | Short-term dual-task training improves cognitive function in dementia -A randomized controlled trial- |
| Date of disclosure of the study information | 2025/12/25 |
| Last modified on | 2025/12/25 23:45:35 |
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Basic information
Public title
Short-term dual-task training improves cognitive function in dementia -A randomized controlled trial-
Acronym
Short-term dual-task training improves cognitive function in dementia -A randomized controlled trial-
Scientific Title
Short-term dual-task training improves cognitive function in dementia -A randomized controlled trial-
Scientific Title:Acronym
Short-term dual-task training improves cognitive function in dementia
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Psychiatry | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to examine the effects of short-duration dual-task training on cognitive function in hospitalized patients with dementia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Outcomes were assessed using the Revised Hasegawa Dementia Scale (HDS-R), the Frontal Assessment Battery (FAB), and the Functional Independence Measure (FIM) at admission, one month, and two months.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The intervention group received brief dual-task training in addition to conventional physical therapy for two months.
Dual-task training involved performing tasks such as the Stroop test, mental arithmetic, number recitation in reverse order, and word chaining while alternately stepping in a seated position for 3 to 6 minutes daily.
Interventions/Control_2
The control group received only conventional physical therapy for two months.
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
HDS-R scored 20 points or lower
Key exclusion criteria
1.HDS-R score of 21 or higher at admission
2.Dementia caused by cerebrovascular disease or the presence of higher brain dysfunction
3.Severe visual or hearing impairment
4.Difficulty in communication
5.Refusal or inability to provide informed consent
6.The presence of disease-specific conditions related to falls, such as Parkinson's disease or Meniere's disease
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Yamanaka |
Organization
Kochi Nishi Hospital
Division name
Department of Rehabilitation
Zip code
780-8040
Address
317-12 Koda, Kochi-city, Kochi
TEL
088-843-1501
main@kochi.jcho.go.jp
Public contact
Name of contact person
| 1st name | Shin |
| Middle name | |
| Last name | Yamanaka |
Organization
Kochi Nishi Hospital
Division name
Department of Rehabilitation
Zip code
780-8040
Address
317-12 Koda, Kochi-city, Kochi
TEL
088-843-1501
Homepage URL
main@kochi.jcho.go.jp
Sponsor or person
Institute
Kochi Nishi Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kochi Nishi Hospital Ethics Committee
Address
317-12 Koda, Kochi-city, Kochi
Tel
088-843-1501
main@kochi.jcho.go.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 | 12 | Month | 25 | 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
22
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
Completed
Date of protocol fixation
| 2023 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 01 | 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 | 12 | Month | 25 | Day |
Last modified on
| 2025 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068863
