UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059856 |
|---|---|
| Receipt number | R000068448 |
| Scientific Title | Development of the index to predict the onset of frailty using accelerometers |
| Date of disclosure of the study information | 2025/11/23 |
| Last modified on | 2025/11/22 13:48:09 |
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Basic information
Public title
Development of a Triaxial Accelerometer Based Index for Predicting the Onset of Physical Frailty
Acronym
TAFI Study (Triaxial Accelerometer Frailty Index Study)
Scientific Title
Development of the index to predict the onset of frailty using accelerometers
Scientific Title:Acronym
TAFI Study (Triaxial Accelerometer Frailty Index Study)
Region
| Japan |
Condition
Condition
Community-dwelling older adults and older patients without physical activity limitations
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will evaluate 24-hour movement behaviors (physical activity, sedentary behavior, and sleep) in community-dwelling older adults and older patients without limitations in physical activity, and examine their association with physical frailty (sarcopenia).
Basic objectives2
Others
Basic objectives -Others
To develop and validate a triaxial accelerometer based index using 24 hour movement behavior data for predicting the onset of physical frailty (sarcopenia) in community dwelling older adults and older patients without limitations in physical activity.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome will be physical frailty (sarcopenia), and the primary exposure variable will be movement data assessed using a wrist-worn triaxial accelerometer. Secondary outcomes will include components of physical frailty (sarcopenia): appendicular skeletal muscle mass, handgrip strength, gait speed, five times sit to stand time, and lower limb muscle strength: as well as health-related quality of life and related measures.
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
| 60 | years-old | <= |
Age-upper limit
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Individuals who are fully independent in all activities of daily living, as indicated by a full score on the Barthel Index.
2. Individuals who, after receiving sufficient explanation about this study and adequately understanding its content, provide consent to participate of their own free will.
Key exclusion criteria
The following individuals will be excluded from this study:
1. Individuals who have disorders of the locomotor system or impaired motor function and are attending a medical facility for this reason.
2. Individuals with an implanted cardiac pacemaker.
In addition, for patients attending an outpatient clinic for internal medicine conditions such as hypertension or dyslipidemia, the following criteria (3 and 4) will also be applied in addition to the above criteria 1 and 2:
3. Individuals whose physical activity is restricted by their attending physician.
4. Individuals whom the principal investigator judges to be otherwise inappropriate for inclusion in this study.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Takuo |
| Middle name | |
| Last name | Nomura |
Organization
Kansai Medical University
Division name
Faculty of Rehabilitation
Zip code
573-1136
Address
18-89, Higasi-machi, Uyama, Hirakata city, Osaka
TEL
072-856-2115
tnomura@ymail.ne.jp
Public contact
Name of contact person
| 1st name | Takuo |
| Middle name | |
| Last name | Nomura |
Organization
Kansai Medical University
Division name
Faculty of Rehabilitation
Zip code
573-1136
Address
18-89, Higasi-machi, Uyama, Hirakata city, Osaka
TEL
072-856-2115
Homepage URL
tnomura@ymail.ne.jp
Sponsor or person
Institute
Kansai Medical University, Faculty of Rehabilitation
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology; Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Review Board of Kansai Medical University
Address
2-5-1, Shin-machi, Hirakata city, Osaka
Tel
072-804-2440
rinriirb@hirakata.kmu.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 | 23 | 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
| 2022 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Collaborating institutions: Tokyo Metropolitan Institute for Geriatrics and Gerontology (Tokyo, Japan), Juntendo University (Tokyo, Japan), Okayama Healthcare Professional University (Okayama, Japan), KKR Takamatsu Hospital (Kagawa, Japan), Misaki Internal Medicine Clinic (Chiba, Japan), and Kansai University of Welfare Sciences (Osaka, Japan).
Management information
Registered date
| 2025 | Year | 11 | Month | 22 | Day |
Last modified on
| 2025 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068448
