UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060954 |
|---|---|
| Receipt number | R000069648 |
| Scientific Title | Examining the Effects of an Intervention to Reduce Sedentary Behavior Among Care-Dependent Older Adults |
| Date of disclosure of the study information | 2026/03/20 |
| Last modified on | 2026/03/17 03:43:27 |
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Basic information
Public title
Examining the Effects of an Intervention Aimed at Reducing Sitting Time
Acronym
Examining the Effects of an Intervention Aimed at Reducing Sitting Time
Scientific Title
Examining the Effects of an Intervention to Reduce Sedentary Behavior Among Care-Dependent Older Adults
Scientific Title:Acronym
Examining the Effects of an Intervention to Reduce Sedentary Behavior Among Care-Dependent Older Adults
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify whether a personalized intervention implementable in daily life can reduce sedentary behavior in community-dwelling care-dependent older adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in total sitting time, continuous sitting time (sitting bouts), and the number of breaks in sitting from baseline to 3 months, measured by an accelerometer (HJA-750C).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
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
In addition to usual home-visit or day-care rehabilitation, participants will receive a 3-month intervention including specific behavior setting to reduce sitting time based on a visualized daily activity timetable, daily recording, weekly feedback, and monthly re-evaluation of physical activity.
Interventions/Control_2
Usual home-visit or day-care rehabilitation only for 3 months
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1,Individuals without the need for acute medical treatment or management, and who are not receiving end-of-life care.
2,Individuals or their primary caregivers who can appropriately manage the physical activity monitor.
3,Individuals with no or mild cognitive impairment (an MMSE score of 20 or higher)
4,Individuals capable of basic mobility and indoor walking at baseline (a Motor FIM score of 5 or higher)
Key exclusion criteria
1,Unsettled environmental adjustments such as welfare equipment
2,Currently receiving measurement and feedback/guidance on physical activity
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Kobayashi |
Organization
Graduate School, University of Tsukuba
Division name
Rehabilitation Science Degree Program
Zip code
112-0012
Address
3-29-1 Otsuka, Bunkyo-ku, Tokyo
TEL
03-3942-6918
s2540265@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Kobayashi |
Organization
Graduate School, University of Tsukuba
Division name
Rehabilitation Science Degree Program
Zip code
112-0012
Address
3-29-1 Otsuka, Bunkyo-ku, Tokyo
TEL
03-3942-6918
Homepage URL
s2540265@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of the Faculty of Human Sciences, University of Tsukuba
Address
3-29-1 Otsuka, Bunkyo-ku, Tokyo
Tel
03-3942-6918
hitorinri@un.tsukuba.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
青葉リハ訪問看護ステーション、青葉リハビリセンター
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 20 | 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 | 03 | Month | 16 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2026 | 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
| 2026 | Year | 03 | Month | 17 | Day |
Last modified on
| 2026 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069648
