UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058803 |
|---|---|
| Receipt number | R000067215 |
| Scientific Title | Characteristics and Factors Linked to Diminished Manual Dexterity in Frail, Community-Dwelling Older Women |
| Date of disclosure of the study information | 2025/08/14 |
| Last modified on | 2025/08/14 17:30:04 |
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Basic information
Public title
Characteristics and Factors Linked to Diminished Manual Dexterity in Frail, Community-Dwelling Older Women
Acronym
Characteristics and Factors Linked to Diminished Manual Dexterity in Frail, Community-Dwelling Older Women
Scientific Title
Characteristics and Factors Linked to Diminished Manual Dexterity in Frail, Community-Dwelling Older Women
Scientific Title:Acronym
Characteristics and Factors Linked to Diminished Manual Dexterity in Frail, Community-Dwelling Older Women
Region
| Japan |
Condition
Condition
Community-dwelling older women
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to elucidate the relationship between manual dexterity and frailty among community-dwelling older women. We compare manual dexterity between frail and robust older women and examined the effect of frailty on manual dexterity under conditions that controlled for age and cognitive function.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Finger dexterity, Grip strength, Upper limb muscle mass, Mini-Mental State Examination, Trail Making Test Part A, Kihon checklist
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Female
Key inclusion criteria
Community-dwelling older women
Key exclusion criteria
(i) participants under 65 years of age, (ii) participants with impaired finger dexterity due to musculoskeletal or central nervous system disorders, (iii) left-handed individuals, (iv) participants with missing measurement data, (v) participants who did not consent to participate in this study, and (vi) participants determined to be prefrail based on the Kihon Checklist (KCL)
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Nakano |
Organization
Kyoto Tachibana University
Division name
Faculty of Health Sciences
Zip code
607-8175
Address
34 Yamada-cho, Oyake, Yamashina-ku, Kyoto-shi, Kyoto
TEL
075-671-1111
nakano-h@tachibana-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Nakano |
Organization
Kyoto Tachibana University
Division name
Faculty of Health Sciences
Zip code
607-8175
Address
34 Yamada-cho, Oyake, Yamashina-ku, Kyoto-shi, Kyoto
TEL
075-571-1111
Homepage URL
nakano-h@tachibana-u.ac.jp
Sponsor or person
Institute
Kyoto Tachibana University
Institute
Department
Personal name
Funding Source
Organization
Kyoto Tachibana 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
Kyoto Tachibana University
Address
34 Yamada-cho, Oyake, Yamashina-ku, Kyoto
Tel
075-571-1111
nakano-h@tachibana-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 | 08 | Month | 14 | 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
191
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 | 03 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cohort study
Management information
Registered date
| 2025 | Year | 08 | Month | 14 | Day |
Last modified on
| 2025 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067215
