UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061379 |
|---|---|
| Receipt number | R000070230 |
| Scientific Title | An interventional study examining the effects and correlates of exercise and health support programs, including the BONE program, on physical function, immune function, cognitive function, posture, blood flow, quality of life, and related comprehensive health indicators in adult men |
| Date of disclosure of the study information | 2026/04/30 |
| Last modified on | 2026/04/26 15:45:07 |
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Basic information
Public title
Effects and associations of exercise and health support programs on physical function, immune function, cognitive function, posture, blood flow, quality of life, and comprehensive health-related indicators in adult men
Acronym
Men's Health Support Study
Scientific Title
An interventional study examining the effects and correlates of exercise and health support programs, including the BONE program, on physical function, immune function, cognitive function, posture, blood flow, quality of life, and related comprehensive health indicators in adult men
Scientific Title:Acronym
An interventional study examining the effects and correlates of exercise and health support programs, including the BONE program, on physical function, immune function, cognitive function, posture, blood flow, quality of life, and related comprehensive health indicators in adult men
Region
| Japan |
Condition
Condition
Adult men who are eligible for assessment of health-related indicators, including health status, physical function, bone density, immune function, cognitive function, posture, blood flow or circulatory function, quality of life, lifestyle, and psychological and behavioral indicators
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine multidimensional changes in and associations among health-related indicators, including bone density, physical function, muscle strength, gait function, cognitive function, posture, quality of life, lifestyle, psychological and behavioral indicators, and blood flow or circulatory function, through exercise and health support programs including the BONE program and related assessments for adult men. The study also aims to exploratorily clarify the effectiveness, safety, feasibility, and applicability of the programs or assessment methods. The target population includes a broad range of adult men, from healthy young adults to middle-aged and older adults. The delivery format is not limited to on-demand delivery and may include face-to-face, remote, home-based, facility-based, or combined formats.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcomes are changes in physical function, bone density, posture, blood flow or circulatory function, quality of life, and comprehensive health-related indicators before and after the intervention or between assessment time points. Specifically, these outcomes may include muscle strength, toe-grip strength, gait function, balance, flexibility, body composition, bone density indices assessed by quantitative ultrasound, posture assessment, indicators related to blood flow or circulatory function, quality of life, and subjective health status.
Key secondary outcomes
Secondary outcomes include immune function, cognitive function, physical activity, exercise adherence, lifestyle, sleep, fatigue, dietary habits, psychological indicators, behavioral indicators, program satisfaction, feasibility, continuation, safety, free-text responses, and other health-related indicators deemed necessary in light of the study objectives.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants in the intervention group will participate in exercise and health support programs, including the BONE program, after providing informed consent and according to the study protocol. The programs may include exercise and health support components aimed at improving trunk function, lower-limb function, posture, flexibility, muscle strength, balance, and physical activity. The delivery format is not limited to on-demand delivery and may include face-to-face, remote, home-based, facility-based, or combined formats. The frequency, duration, session length, and delivery method will be determined according to the study protocol. Assessments of physical function, bone density, cognitive function, posture, blood flow or circulatory function, quality of life, lifestyle, and subjective health status may be conducted before and after the intervention or between assessment time points.
Interventions/Control_2
Participants in the control group will continue their usual lifestyle or usual activities during the study period. Similar to the intervention group, assessments of physical function, bone density, cognitive function, posture, blood flow or circulatory function, quality of life, lifestyle, and subjective health status may be conducted before and after the observation period or between assessment time points according to the study protocol.
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
| 18 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male
Key inclusion criteria
Eligible participants are individuals who meet the following criteria:
Adult men.
Individuals ranging from healthy young adult men to middle-aged and older adult men who are able to participate in the assessments or interventions specified in the study protocol.
Individuals who provide informed consent to participate in the study.
Individuals who are able to participate in exercise and health support programs including the BONE program, physical function assessments, bone density measurements, cognitive function assessments, posture assessments, blood flow or circulatory function assessments, quality-of-life assessments, lifestyle surveys, and subjective assessments.
Individuals who are able to participate in assessments or interventions delivered at facilities, at home, face-to-face, remotely, on demand, or through combined methods specified in the study protocol.
Key exclusion criteria
Individuals who meet any of the following criteria will be excluded:
Individuals who are judged to have difficulty participating in the intervention or assessments.
Individuals who have been restricted from exercising by a physician or other healthcare professional.
Individuals with serious disease, pain, injury, neuromuscular disorders, cardiovascular disease, or other medical conditions that may interfere with participation.
Individuals who cannot provide informed consent to participate in the study.
Individuals who are judged by the principal investigator or co-investigators to be inappropriate for participation in this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shiho |
| Middle name | |
| Last name | Kurosaka |
Organization
Hiroshima University
Division name
Graduate School of Humanities and Social Sciences
Zip code
739-8524
Address
1-1-1 Kagamiyama, Higashihiroshima- ,sih Hiroshima, Japan
TEL
082-424-6844
shihok@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Shiho |
| Middle name | |
| Last name | Kurosaka |
Organization
Hiroshima University
Division name
Graduate School of Humanities and Social Sciences
Zip code
739-8524
Address
1-1-1 Kagamiyama, Higashihiroshima- ,sih Hiroshima, Japan
TEL
082-424-6844
Homepage URL
shihok@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima 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
Hiroshima University
Address
1-1-1 Kagamiyama, Higashihiroshima- ,sih Hiroshima, Japan
Tel
082-424-6844
shihok@hiroshima-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 | 04 | Month | 30 | 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 | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 30 | 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 | 04 | Month | 26 | Day |
Last modified on
| 2026 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070230
