UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061639 |
|---|---|
| Receipt number | R000070528 |
| Scientific Title | An observational study using measurement data from the continuous exercise support program "Marianna Muscle Strengthening Program" for health promotion among community-dwelling older adults |
| Date of disclosure of the study information | 2026/05/20 |
| Last modified on | 2026/05/20 13:59:54 |
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Basic information
Public title
An observational study of health and physical function using measurement data from the "Marianna Muscle Strengthening Program" for community-dwelling older adults
Acronym
Marianna Muscle Strengthening Program Observational Study
Scientific Title
An observational study using measurement data from the continuous exercise support program "Marianna Muscle Strengthening Program" for health promotion among community-dwelling older adults
Scientific Title:Acronym
MMSP Observational Study
Region
| Japan |
Condition
Condition
Health promotion and physical function maintenance in community-dwelling older adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the distribution, longitudinal changes, and associations among physical function, body composition, and questionnaire variables routinely collected in the "Marianna Muscle Strengthening Program" for community-dwelling older adults, and to generate fundamental evidence for the implementation and evaluation of exercise support programs.
Basic objectives2
Others
Basic objectives -Others
Exploratory observational analysis of the distribution, longitudinal changes, and associations among physical function, body composition, and questionnaire-based measures in community-dwelling older adults.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes and associations in body composition and physical function indicators, including body weight, body fat percentage, muscle mass, skeletal muscle index (SMI), 30-second chair stand test, one-leg standing test, sit-and-reach test, grip strength, and gait speed.
Key secondary outcomes
Participant characteristics, exercise participation records, questionnaire-based indices, and environmental measurements, including age, sex, height, training frequency, Locomo25 score, locomotive syndrome category, sarcopenia category, frailty category, room temperature, humidity, and wet-bulb globe temperature (WBGT).
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
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adults aged 65 years or older living or working in Kawasaki City who participate in the "Marianna Muscle Strengthening Program," have routine program measurement data available, are eligible for research use according to protocol-defined consent procedures (opt-out or written informed consent), and have no missing data in analysis variables.
Key exclusion criteria
Individuals not eligible for research use according to protocol-defined consent procedures (opt-out or written informed consent), or those with missing data in analysis variables.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Hiroto |
| Middle name | |
| Last name | Fujiya |
Organization
St.Marianna University School of Medicine
Division name
Department of Sports Medicine
Zip code
2168511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa, Japan
TEL
044-977-8111
fujiya-1487@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Fumiko |
| Middle name | |
| Last name | Terawaki |
Organization
St.Marianna University School of Medicine
Division name
Department of Sports Medicine
Zip code
2168511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa, Japan
TEL
08019085572
Homepage URL
f.terra@marianna-u.ac.jp
Sponsor or person
Institute
St.Marianna University School of Medicine
Institute
Department
Personal name
FUMIKO TERAWAKI
Funding Source
Organization
St.Marianna University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St.Marianna University School of Medicine, Graduate School and Research Promotion Division
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa, Japan
Tel
044-977-8111
k-shienbu.mail@marianna-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 | 05 | Month | 20 | 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 | 05 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2035 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a mixed observational study including retrospective data analysis and prospective data collection. Recruitment and data collection for the prospective component will begin after ethics approval.
Management information
Registered date
| 2026 | Year | 05 | Month | 20 | Day |
Last modified on
| 2026 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070528
