UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063190 |
|---|---|
| Receipt number | R000072318 |
| Scientific Title | Changes in Physical Function and Health-Related Outcomes Before and After Participation in a Health Promotion Program Among Community-Dwelling Middle-Aged and Older Adults |
| Date of disclosure of the study information | 2026/10/15 |
| Last modified on | 2026/10/06 14:48:48 |
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Basic information
Public title
Changes in Physical Function and Health-Related Outcomes Before and After Participation in a Health Promotion Program Among Community-Dwelling Middle-Aged and Older Adults
Acronym
Changes in Physical Function and Health-Related Outcomes Before and After Participation in a Health Promotion Program Among Community-Dwelling Middle-Aged and Older Adults
Scientific Title
Changes in Physical Function and Health-Related Outcomes Before and After Participation in a Health Promotion Program Among Community-Dwelling Middle-Aged and Older Adults
Scientific Title:Acronym
Changes in Physical Function and Health-Related Outcomes Before and After Participation in a Health Promotion Program Among Community-Dwelling Middle-Aged and Older Adults
Region
| Japan |
Condition
Condition
community-dwelling middle-aged and older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate changes in physical function and health-related outcomes before and after participation in a health promotion program among community-dwelling middle-aged and older adults.
Basic objectives2
Others
Basic objectives -Others
To exploratively examine changes in body composition, life-space mobility, and health-related quality of life, as well as the associations of postural control, cognitive function, self-perception of physical ability, and obstacle-crossing performance with physical function.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in physical function and ankle joint position sense before and after participation in the health promotion program. Physical function will be assessed using the 30-second Chair Stand Test (CS-30), 10-m walking test at comfortable and maximum speeds, handgrip strength, and the Timed Up and Go test (TUG). Somatosensory function will be assessed using ankle joint position sense.
Key secondary outcomes
Secondary outcomes include toe grip strength, body composition, Life-Space Assessment (LSA), the 8-item Short Form Health Survey (SF-8), the Kihon Checklist (KCL), center of pressure (COP) measures, estimation errors of physical ability assessed using the Functional Reach Test (FRT) and the Two-Step Test, obstacle-crossing performance, and cognitive function assessed using the Japanese version of the Montreal Cognitive Assessment (MoCA-J).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Participants will attend a health promotion program consisting of seven 90-minute sessions over approximately six months. The program will include health education provided by physical therapists, physical function assessments, muscle strengthening exercises, posture and gait training, balance exercises, and education and exercises related to cognitive and physical function. Participants will also be instructed to perform home-based exercises between sessions.
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
| 55 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Community-dwelling middle-aged and older adults aged approximately 50 years or older who reside in Seki City or Kakamigahara City.
2. Participants enrolled in the Chubu Gakuin University City College health promotion program.
3. Individuals who have received sufficient information about the study and provided written informed consent to participate.
4. Individuals who are able to understand the study instructions and safely perform standing, walking, and physical function assessments.
Key exclusion criteria
1. Individuals who do not meet the age criterion for inclusion.
2. Individuals who do not provide written informed consent to participate in the study.
3. Individuals who have difficulty understanding instructions or communicating sufficiently to complete the assessments appropriately.
4. Individuals with acute pain, dizziness, dyspnea, or other physical symptoms on the day of assessment that are considered by the investigators to preclude safe participation.
5. Individuals who are unable to safely perform standing, walking, obstacle-crossing, or other physical assessments.
6. Individuals who are otherwise considered unsuitable for participation by the investigators.
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Suganuma |
Organization
Chubu Gakuin University
Division name
Department of Physical Therapy, Faculty of Nursing and Rehabilitation
Zip code
501-3993
Address
2-1 Kirigaoka, Seki, Gifu 501-3993, Japan
TEL
08052907737
suganuma-junichi@chubu-gu.ac.jp
Public contact
Name of contact person
| 1st name | Junichi |
| Middle name | |
| Last name | Suganuma |
Organization
Chubu Gakuin University
Division name
Department of Physical Therapy, Faculty of Nursing and Rehabilitation
Zip code
501-3993
Address
2-1 Kirigaoka, Seki, Gifu 501-3993, Japan
TEL
08052907737
Homepage URL
suganuma-junichi@chubu-gu.ac.jp
Sponsor or person
Institute
Chubu Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Chubu Gakuin 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
Chubu Gakuin University
Address
2-1 Kirigaoka, Seki, Gifu 501-3993, Japan
Tel
08052907737
suganuma-junichi@chubu-gu.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 | 10 | Month | 15 | 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 | 10 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 25 | 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 | 10 | Month | 06 | Day |
Last modified on
| 2026 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072318
