UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059798 |
|---|---|
| Receipt number | R000068372 |
| Scientific Title | Effectiveness Evaluation of a Dual-Task Exercise Intervention Aimed at Improving the Well-being of Residents in Elderly Welfare Facilities |
| Date of disclosure of the study information | 2025/11/17 |
| Last modified on | 2025/11/16 22:27:02 |
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Basic information
Public title
Effectiveness Evaluation of a Dual-Task Exercise Intervention Aimed at Improving the Well-being of Residents in Elderly Welfare Facilities
Acronym
Effectiveness Evaluation of a Dual-Task Exercise Intervention Aimed at Improving the Well-being of Residents in Elderly Welfare Facilities
Scientific Title
Effectiveness Evaluation of a Dual-Task Exercise Intervention Aimed at Improving the Well-being of Residents in Elderly Welfare Facilities
Scientific Title:Acronym
Effectiveness Evaluation of a Dual-Task Exercise Intervention Aimed at Improving the Well-being of Residents in Elderly Welfare Facilities
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study applies multifactorial interventions to elderly individuals requiring care, specifically clarifying the effects of dual-task exercise interventions (e.g., performing limb movements while performing calculations). The significance of this research lies in demonstrating that dual-task exercise is effective for enhancing well-being in elderly individuals requiring care-achieving a state of physical and mental health even with dementia, or maintaining cognitive function even while using a wheelchair.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Well-being Indicators (Subjective Assessment via Self-Report)
#Health-Related Quality of Life (EQ-5D-5L)
#Mental Health (GDS-15)
#Satisfaction (Global Rating of Change Scale)
Key secondary outcomes
Cognitive Function Tests (Objective Assessment by Healthcare Professionals)
#Mini-Mental State Examination (MMSE)
#ABC Dementia Scale
#MIRUDAKE
Physical Function Tests (Objective Assessment by Healthcare Professionals)
#Grip Strength
#Short Physical Performance Battery (SPPB)
#Barthel Index
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
In addition to standard exercise rehabilitation, perform dual-task exercises for 15 minutes.
Interventions/Control_2
standard exercise rehabilitation
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Individuals requiring support or care levels 1 to 3
2) Individuals aged 60 or older
3) Individuals who can obtain consent and a signature on the consent form from themselves or their family
Key exclusion criteria
1) Individuals with injuries or medical conditions that may affect their ability to perform the exercise
2) Individuals currently participating in other studies or programs involving exercise
3) Individuals deemed ineligible for study participation by a physician
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Hisatomo |
| Middle name | |
| Last name | Kowa |
Organization
Kobe University Graduate School of Health Sciences
Division name
Research Center of Preventing Cognitive Disorder
Zip code
654-0142
Address
7-10-2 Tomogaoka, Suma-ku Kobe 654-0142, Japan
TEL
078-796-4514
yuma@dragon.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuma |
| Middle name | |
| Last name | Sonoda |
Organization
Kobe University Graduate School of Health Sciences
Division name
Research Center of Preventing Cognitive Disorder
Zip code
654-0142
Address
7-10-2 Tomogaoka, Suma-ku Kobe 654-0142, Japan
TEL
078-796-4514
Homepage URL
yuma@dragon.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Himedic, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Health Sciences Ethics Committee
Address
7-10-2 Tomogaoka, Suma-ku Kobe 654-0142, Japan
Tel
078-796-4502
syomu2@ams.kobe-u.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 | 11 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 17 | 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
| 2025 | Year | 11 | Month | 16 | Day |
Last modified on
| 2025 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068372
