UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062988 |
|---|---|
| Receipt number | R000072112 |
| Scientific Title | Changes in Calcaneal Speed of Sound, Toe Grip Strength, and Salivary Secretory Immunoglobulin A During a 4-Month Home-Based On-Demand Bone-Specific Exercise Program in Adult Women |
| Date of disclosure of the study information | 2026/09/18 |
| Last modified on | 2026/09/18 22:08:34 |
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Basic information
Public title
Changes in Bone Status and Physical Function During a 4-Month Home-Based On-Demand Bone Exercise Program in Adult Women
Acronym
BONE On-Demand Study
Scientific Title
Changes in Calcaneal Speed of Sound, Toe Grip Strength, and Salivary Secretory Immunoglobulin A During a 4-Month Home-Based On-Demand Bone-Specific Exercise Program in Adult Women
Scientific Title:Acronym
BONE On-Demand Study
Region
| Japan |
Condition
Condition
Decline in bone health and physical function in adult women
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine changes in calcaneal speed of sound (SOS) associated with participation in a 4-month home-based, on-demand Building Osteo Neatly Exercise (BONE) program in adult women compared with a no-intervention control group.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Right calcaneal speed of sound (SOS, m/s) assessed by quantitative ultrasound at baseline and after 4 months.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
BONE intervention group. Participants perform the home-based, on-demand Building Osteo Neatly Exercise (BONE) program using prerecorded exercise videos. Each session lasts 30 minutes and is performed twice weekly for 4 months. Participants perform the exercises barefoot while following the demonstrated movement sequence and musical rhythm.
Interventions/Control_2
Control group. Participants do not participate in the BONE program during the 4-month study period and continue their usual daily activities.
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
| Not applicable |
Gender
Female
Key inclusion criteria
1. Adult women.
2. Able to independently complete approximately 30 minutes of exercise.
3. Able to provide written informed consent to participate in the study.
Key exclusion criteria
Individuals with a serious medical condition or a contraindication to exercise.
Target sample size
40
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, Higashi-Hiroshima City, Hiroshima 739-8524, Japan
TEL
082-424-6705
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, Higashi-Hiroshima City, Hiroshima 739-8524, Japan
TEL
082-424-6705
Homepage URL
shihok@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Humanities and Social Sciences, Hiroshima University
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Review Board, Graduate School of Humanities and Social Sciences, Hiroshima University
Address
1-1-1 Kagamiyama, Higashi-Hiroshima City, Hiroshima 739-8524, Japan
Tel
082-424-6705
ed-ken-zai@office.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 | 09 | Month | 18 | 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
40
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
Completed
Date of protocol fixation
| 2026 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 04 | 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 | 09 | Month | 18 | Day |
Last modified on
| 2026 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072112
