UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063136 |
|---|---|
| Receipt number | R000072269 |
| Scientific Title | The impact of exercise therapy intervention combined with Attention Process Training (APT) on attention function and fall risk in elderly individuals requiring care residing in nursing homes. |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/10/01 20:57:41 |
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Basic information
Public title
The impact of exercise therapy intervention combined with Attention Process Training (APT) on attention function and fall risk in elderly individuals requiring care residing in nursing homes.
Acronym
The impact of exercise therapy intervention combined with Attention Process Training (APT) on attention function and fall risk in elderly individuals requiring care residing in nursing homes.
Scientific Title
The impact of exercise therapy intervention combined with Attention Process Training (APT) on attention function and fall risk in elderly individuals requiring care residing in nursing homes.
Scientific Title:Acronym
The impact of exercise therapy intervention combined with Attention Process Training (APT) on attention function and fall risk in elderly individuals requiring care residing in nursing homes.
Region
| Japan |
Condition
Condition
Elderly individuals aged 65 or older requiring long-term care who are residing in a care facility.
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate whether combining Attention Process Training (APT) a method for training attentional processes with exercise therapy improves attention and reduces fall risk among elderly individuals requiring long term care who reside in care facilities. As this is a novel initiative applying APT to this population with a specific focus on fall risk, the study serves as preliminary research designed to assess the feasibility of the APT intervention.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intervention compliance rate
Completion rate
Dropout rate
4
Reason for cancellation
Key secondary outcomes
Span test
Cancellation and Detection test
Memory Updating test
paced auditory serial addition test
continuous performance test
Berg Balance Scale
Timed Up and Go test
10 meter walk
Dual Task 10 meter walk
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
For three months, perform 30 minutes of APT in addition to 30 minutes of exercise therapy, twice a week.
Interventions/Control_2
Perform 30 minutes of exercise therapy twice a week for three 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
Participants who meet the following criteria and consent to the study will be enrolled: elderly individuals aged 65 or older requiring long-term care who reside in the facility and utilize the day-care service where this study is conducted, and who score 21 points or higher on the Japanese version of the Mini-Mental State Examination (MMSE-j).
Key exclusion criteria
Individuals falling under any of the following categories are excluded:
Difficulty maintaining a standing position for a certain period of time
Difficulty walking 10 meters or more, even with the use of walking aids
Difficulty communicating or understanding the purpose of the study
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | Nobuaki |
| Middle name | |
| Last name | hamazaki |
Organization
Kitasato University
Division name
Department of Physical Therapy, School of Medical and Health Sciences
Zip code
252-0373
Address
1-15-1 Kitasato, Minami-ku, Sagamihara City, Kanagawa Prefecture
TEL
042-778-9567
hamanobu@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Nakagawa |
Organization
Care Staff Ltd.
Division name
Rehabilitation Day Care Department: Reha-Remake Yokokawa-cho
Zip code
1930823
Address
550-50 Yokokawa-machi, Hachioji City, Tokyo
TEL
0426861223
Homepage URL
care136@outlook.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
NO
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
Research Ethics Review Committee, School of Allied Health Sciences, Kitasato University
Address
18 1-15-1 Kitasato, Minami-ku, Sagamihara City, Kanagawa Prefecture
Tel
042-778-9173
a-kyoumu@kitasato-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
| 2026 | Year | 10 | Month | 01 | 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
| 2026 | Year | 09 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2028 | Year | 02 | Month | 28 | 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 | 10 | Month | 01 | Day |
Last modified on
| 2026 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072269
