UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063142 |
|---|---|
| Receipt number | R000072272 |
| Scientific Title | Physical fitness survey of community residents living near Shonan University of Medical Sciences |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/10/01 23:25:45 |
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Basic information
Public title
Physical Fitness Survey of Residents in the Area Surrounding Shonan Medical University: A Survey Measuring Muscle Strength, Balance, Walking Speed, and Muscle Mass
Acronym
Community Fitness Survey
Scientific Title
Physical fitness survey of community residents living near Shonan University of Medical Sciences
Scientific Title:Acronym
SUMS Community Fitness Survey
Region
| Japan |
Condition
Condition
To continuously measure physical fitness, including muscle strength, balance, walking ability, and muscle mass, in community residents living near Shonan University of Medical Sciences, and to clarify fitness levels by age group and sex. The accumulated data will also be used to examine longitudinal changes and to build evidence for health promotion among local residents.
Classification by specialty
| Geriatrics | Rehabilitation medicine | Adult |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Measurements will be conducted at an annual university festival and at community fitness assessment events for older adults held in spring and autumn. Measured items are grip strength, isometric knee extension strength, one-leg standing time, functional reach distance, walking speed, and body composition (body weight and appendicular skeletal muscle mass index). Each session takes no more than 30 minutes, and participants may choose which items to undergo.
Basic objectives2
Others
Basic objectives -Others
Description of physical fitness levels in community residents
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Grip strength
Key secondary outcomes
Knee extension strength (normalized to body weight; kgf/kg), one-leg standing time, functional reach distance, 10-m walking time (walking speed), body weight, appendicular skeletal muscle mass index (SMI), history of falls in the past year, and adverse events during measurement
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
| 10 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Community residents living near Shonan University of Medical Sciences (Totsuka Ward, Yokohama) (2) Individuals who wish to participate in the university festival or in community fitness assessment events for older adults (3) Individuals who provided written informed consent (for minors, consent from both the participant and a parent or guardian)
Key exclusion criteria
(1) Resting pulse rate of 40 beats/min or less, or 120 beats/min or more before measurement (2) Resting systolic blood pressure of 80 mmHg or less, or 160 mmHg or more before measurement (3) Individuals judged by the investigators to be unsuitable for measurement because of a current medical condition or their physical condition on the day
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Morio |
Organization
Shonan University of Medical Sciences
Division name
Department of Rehabilitation, Faculty of Medical Sciences
Zip code
244-0806
Address
16-48, Kamishinano, Totsuka-ku, Yokohama-ctiy, Kanagawa, JAPAN
TEL
+81-45-821-0111
yuji.morio@sums.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Morio |
Organization
Shonan University of Medical Sciences
Division name
Department of Rehabilitation, Faculty of Medical Sciences
Zip code
244-0806
Address
16-48, Kamishinano, Totsuka-ku, Yokohama-ctiy, Kanagawa, JAPAN
TEL
+81-45-821-0111
Homepage URL
yuji.morio@sums.ac.jp
Sponsor or person
Institute
Shonan University of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Shonan University of Medical Sciences
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 Committee, Shonan University of Medical Sciences
Address
16-48, Kamishinano, Totsuka-ku, Yokohama-ctiy, Kanagawa, JAPAN
Tel
+81-45-821-0111
kenkyujimu@sums.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
26-029
Org. issuing International ID_1
Research Ethics Committee, Shonan University of Medical Sciences
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
湘南医療大学/ Shonan University of Medical Sciences、シニアホテル東戸塚サウスウイング/ Senior Hotel Higashi-Totsuka South Wing
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 | 08 | Month | 24 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an observational study of community residents who wish to participate in fitness measurements held at an annual university festival and at community fitness assessment events for older adults in spring and autumn. Blood pressure and pulse rate are checked before measurement, and all measurements are supervised by physical therapists with attention to fall prevention. Participants receive a results sheet. Because some individuals participate repeatedly, the target sample size refers to the total number of measurements. This study extends the period of a previous protocol (approval No. 23-015) and adds body composition measurement and a new measurement site.
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=R000072272
