UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055859 |
|---|---|
| Receipt number | R000060890 |
| Scientific Title | The impact of an occupational dysfunction-focused care prevention program on the prevention of frailty |
| Date of disclosure of the study information | 2024/10/17 |
| Last modified on | 2025/08/18 10:49:52 |
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Basic information
Public title
Effectiveness of a care prevention programme focused on occupational dysfunction in preventing frailty.
Acronym
Effectiveness of a care prevention programme focused on occupational dysfunction in preventing frailty.
Scientific Title
The impact of an occupational dysfunction-focused care prevention program on the prevention of frailty
Scientific Title:Acronym
The impact of an occupational dysfunction-focused care prevention program on the prevention of frailty
Region
| Japan |
Condition
Condition
Older adults living in the community
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the preventive effect on frailty of a care-prevention programme that adds a care-prevention programme focusing on occupational dysfunction (e.g. reflecting on one's lifestyle and rhythm of life, setting goals for life, etc.) to the conventional exercise-based care-prevention programme.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The revised Japanese version of the Cardiovascular Health Study criteria, Kihon Checklist, UCLA Loneliness Scale, Lubben Social Network Scale-6.
The above evaluations are conducted before and after the program, as well as three months, six months, one year, and two years after the program ends.
Key secondary outcomes
age, sex, Height, weight, body mass index, medical history, smoking status, household composition, educational status, economic status, skeletal muscle mass, SF-12, geriatric depression scale, classification and assessment of occupational dysfunction, self-completed occupational performance index, satisfaction with daily activities, health literacy scale-14, grip strength, five-times sit-to-stand Test, timed up & go, gait speed
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Intervention group: Care prevention program combining resistance exercise with a lecture on health focused on occupational dysfunction.
This program will be carried out once a week for a period of three months.
Interventions/Control_2
Control group: Care prevention program combining resistance exercise with lectures on general medical knowledge.
This program will be carried out once a week for a period of three 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) 65 years or older
2) Those who live at home
3) Independent in activities of daily living
4) Those who have agreed to participate in the study.
Key exclusion criteria
1) Those who have been advised by a physician not to exercise
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Fujii |
Organization
Suzuka University of Medical Science
Division name
Faculty of Health Science
Zip code
510-0293
Address
1001-1 Kishioka, Suzuka, Mie
TEL
+81(0)59-383-8991
fujii@suzuka-u.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Fujii |
Organization
Suzuka University of Medical Science
Division name
Faculty of Health Science
Zip code
510-0293
Address
1001-1 Kishioka, Suzuka, Mie
TEL
+81(0)59-383-8991
Homepage URL
fujii@suzuka-u.ac.jp
Sponsor or person
Institute
Suzuka University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
The research ethics committee of Suzuka University of Medical Science
Address
1001-1 Kishioka, Suzuka, Mie
Tel
+81(0)59-383-8991
fujii@suzuka-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
| 2024 | Year | 10 | Month | 17 | 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
46
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2026 | Year | 09 | Month | 30 | Day |
Other
Other related information
Progressing as of August 2025
Management information
Registered date
| 2024 | Year | 10 | Month | 17 | Day |
Last modified on
| 2025 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060890
