UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059541 |
|---|---|
| Receipt number | R000068091 |
| Scientific Title | Examination of the Effects of an Exercise Programme Utilising Wearable Care Robots on Social Frailty in Community-Dwelling Older Adults |
| Date of disclosure of the study information | 2025/10/26 |
| Last modified on | 2025/10/26 13:14:38 |
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Basic information
Public title
Examination of the Effects of an Exercise Programme Utilising Wearable Care Robots on Social Frailty in Community-Dwelling Older Adults
Acronym
Examination of the Effects of an Exercise Programme Utilising Wearable Care Robots on Social Frailty in Community-Dwelling Older Adults
Scientific Title
Examination of the Effects of an Exercise Programme Utilising Wearable Care Robots on Social Frailty in Community-Dwelling Older Adults
Scientific Title:Acronym
Examination of the Effects of an Exercise Programme Utilising Wearable Care Robots on Social Frailty in Community-Dwelling Older Adults
Region
| Japan |
Condition
Condition
frailty
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the impact of an exercise programme utilising wearable care robots for community-dwelling older adults on social frailty, thereby clarifying its usefulness for care prevention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Makizako's indicators
Key secondary outcomes
Life space assessment, 10m standard walking speed, Timed Up and Go test (TUG), five-time chair stand test, Body Mass Index, surface electromyography during standing movements (erector spinae and rectus femoris), Japanese version of International Physical Activity Questionnaire (IPAQ)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Participants will wear a wearable care robot and undertake an exercise programme lasting approximately 60 minutes per session, twice weekly for five weeks (totalling 10 sessions). The exercise programme will involve seated and standing tasks. The content of the exercise programme will be adjusted in terms of frequency and intensity to suit the physical capabilities of each research subject.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Not certified as requiring support or nursing care
Those meeting the Japanese frailty criteria
Key exclusion criteria
Exercise is prohibited by the doctor.
Unable to walk unaided
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Taki |
Organization
Hiroshima University
Division name
Graduate school of human and social sciences
Zip code
739-8511
Address
1-7-1 Kagamiyama, Higashihiroshima City, Hiroshima
TEL
082-242-6838
staki@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Taki |
Organization
Hiroshima University
Division name
Graduate school of human and social sciences
Zip code
739-8511
Address
1-7-1 Kagamiyama, Higashihiroshima City, Hiroshima
TEL
082-242-6838
Homepage URL
staki@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Public Interest Incorporated Foundation France Bed Home Care Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University
Address
1-7-1 Kagamiyama, Higashihiroshima City, Hiroshima
Tel
082-242-6838
staki@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
| 2025 | Year | 10 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2027 | Year | 03 | 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 | 10 | Month | 26 | Day |
Last modified on
| 2025 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068091
