UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061376 |
|---|---|
| Receipt number | R000070229 |
| Scientific Title | An interventional study examining the effects and correlations of exercise and health support programs including the BONE program on physical function, immune function, cognitive function, posture, quality of life, and comprehensive health indicators in middle-aged and older adult women |
| Date of disclosure of the study information | 2026/04/26 |
| Last modified on | 2026/04/26 13:57:22 |
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Basic information
Public title
Effects and associations of exercise and health support programs including the BONE program on physical function, immune function, cognitive function, posture, and comprehensive health-related indicators in middle-aged and older adult women
Acronym
BONE Health Study
Scientific Title
An interventional study examining the effects and correlations of exercise and health support programs including the BONE program on physical function, immune function, cognitive function, posture, quality of life, and comprehensive health indicators in middle-aged and older adult women
Scientific Title:Acronym
BONE Health Support Study
Region
| Japan |
Condition
Condition
Middle-aged and older adult women with concerns regarding aging, physical inactivity, decreased physical activity, reduced bone density, decreased immune function, reduced physical function, cognitive decline, impaired posture-related function, and decreased health-related 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 correlations among bone density, immune function, muscle strength, gait function, cognitive function, posture, quality of life, lifestyle, psychological and behavioral indicators, and subjective health status through the implementation of exercise and health support programs including the BONE program for middle-aged and older adult women, and to exploratorily clarify the effectiveness, safety, feasibility, and applicability of the programs. The programs may be delivered face-to-face, online, on demand, at home, in facilities, or through a combination of these methods. This study may also include other related experiments, measurements, questionnaires, physical function assessments, cognitive function assessments, posture assessments, psychological and behavioral assessments, and feasibility assessments beyond those listed above.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcomes are changes in bone density, immune function, physical function, and comprehensive health-related indicators before and after the intervention. These may include calcaneal indices assessed by quantitative ultrasound, immune indicators such as salivary IgA, lower-limb muscle strength, toe-grip strength, gait speed, posture, cognitive function, and quality of life. Changes in each indicator, between-group differences, and correlations among outcome measures will also be examined.
Key secondary outcomes
Secondary outcomes include physical activity, exercise adherence, lifestyle, subjective health status, psychological indicators, behavioral indicators, cognitive function, posture-related indicators, balance function, flexibility, fall-related risk, free-text responses, satisfaction with the program, sustainability, safety, feasibility, and associations among outcome measures. Other physical, psychological, behavioral, physiological, and social health-related indicators may also be exploratorily collected and analyzed as needed.
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 who provide informed consent will be randomly allocated to the intervention group or the control group. Participants in the intervention group will perform exercise and health support programs including the BONE program for a specified period. The programs may include components designed to maintain or improve bone and muscle function, gait function, postural control, physical activity, cognitive function, quality of life, and comprehensive health-related indicators. The delivery method is not limited to on-demand distribution; the programs may be delivered face-to-face, online, on demand, at home, in facilities, or through a combination of these methods. The frequency, duration, and intervention period will be determined according to the study protocol, participant conditions, safety considerations, and feasibility.
Interventions/Control_2
Participants in the control group will not perform the exercise or health support programs including the BONE program specified in the study during the same period and will continue their usual lifestyle or usual activities. Similar to the intervention group, health checks, physical function assessments, immune function assessments, cognitive function assessments, posture assessments, quality-of-life questionnaires, lifestyle surveys, subjective assessments, and related evaluations may be conducted before and after the study period.
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
Female
Key inclusion criteria
Adult women, including middle-aged and older adults
Individuals who receive an explanation of the study and provide informed consent to participate
Individuals who are able to participate in exercise and health support programs including the BONE program, health checks, physical function assessments, immune function assessments, cognitive function assessments, posture assessments, quality-of-life surveys, lifestyle surveys, subjective assessments, and related evaluations
Individuals who are able to participate in interventions or assessments delivered face-to-face, online, on demand, at home, in facilities, or through a combination of these methods
Individuals who are able to participate in the study while continuing their usual lifestyle or usual activities
Key exclusion criteria
Individuals who have been prohibited from exercising by a physician or other healthcare professional
Individuals who are judged to have difficulty completing the intervention or assessments
Individuals with serious disease, acute symptoms, or orthopedic, neurological, or cardiovascular problems that may interfere with exercise participation
Individuals who do not 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- s,ih 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 -,ishHiroshima, 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 | 26 | 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 | 26 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 26 | 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=R000070229
