UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060202 |
|---|---|
| Receipt number | R000068855 |
| Scientific Title | Effectiveness of Feedback Using a Physical Activity Visualization Tool in Older Adults Participating in a Long-Term Care Prevention Program: A Pilot Quasi-Experimental Study |
| Date of disclosure of the study information | 2025/12/30 |
| Last modified on | 2025/12/26 11:07:12 |
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Basic information
Public title
Effectiveness of Feedback Using a Physical Activity Visualization Tool in Older Adults Participating in a Long-Term Care Prevention Program: A Pilot Quasi-Experimental Study
Acronym
PA-Vis Feedback Pilot
Scientific Title
Effectiveness of Feedback Using a Physical Activity Visualization Tool in Older Adults Participating in a Long-Term Care Prevention Program: A Pilot Quasi-Experimental Study
Scientific Title:Acronym
PA-VisFB-QE Pilot
Region
| Japan |
Condition
Condition
Participants in Day Service Type C under the Long-Term Care Prevention and Daily Life Support Service Program
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effect of feedback augmented with a physical activity visualization tool, compared with conventional numeric-only feedback, in older adults using a long-term care prevention program (Day Service Type C).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of daily physical activity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
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
Intervention: action planning with visual feedback
Interventions/Control_2
Control: action planning with numeric-only feedback
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
Users of the Long-Term Care Prevention and Daily Life Support Service Program (Day Service Type C)
Aged 65 years or older
Individuals whose stage in Prochaska's Transtheoretical Model of Behavior Change is at least the contemplation stage (i.e., intending to take action toward behavior change within the next 6 months)
Individuals certified as requiring support level 1 or 2 (Yo-shien 1 or 2), or those who meet at least one criterion on the Basic Checklist (Kihon Checklist)
Key exclusion criteria
Individuals who have previously participated in a long-term care prevention program or have received physical activity feedback from healthcare professionals
Individuals with a Dementia Independence Degree for Daily Living of II or higher
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Kimura |
Organization
Toyo University
Division name
Faculty of Life Sciences, Department of Biomedical Engineering
Zip code
351-8510
Address
48-1 Oka, Asaka-shi, Saitama, Japan
TEL
048-468-6311
kimura008@toyo.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Kimura |
Organization
Toyo University
Division name
Faculty of Life Sciences, Department of Biomedical Engineering
Zip code
351-8510
Address
48-1 Oka, Asaka-shi, Saitama, Japan
TEL
048-468-6311
Homepage URL
kimura008@toyo.jp
Sponsor or person
Institute
Toyo University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Hatsudai Rehabilitation Hospital
Address
3-53-3 Honmachi, Shibuya-ku, Tokyo, Japan
Tel
03-5365-8500
yy930302@gmail.com
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
| 2025 | Year | 12 | 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
| 2025 | Year | 11 | Month | 14 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 25 | Day |
Last modified on
| 2025 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068855
