UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044706 |
|---|---|
| Receipt number | R000051062 |
| Scientific Title | A prospective, randomized, open-blinded, multi-center, pilot study assessing the effectiveness of the frailty prevention program for older workers |
| Date of disclosure of the study information | 2021/06/30 |
| Last modified on | 2023/02/28 11:12:32 |
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Basic information
Public title
Effect of the frailty prevention program on occupational safety for older workers: a pilot study
Acronym
A pilot study of the frailty prevention programs for occupational safety
Scientific Title
A prospective, randomized, open-blinded, multi-center, pilot study assessing the effectiveness of the frailty prevention program for older workers
Scientific Title:Acronym
A pilot effectiveness trial of the frailty prevention program for occupational safety
Region
| Japan |
Condition
Condition
fall risks
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Preliminarily examine the effectiveness of the frailty prevention program on occupational safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
The sit-to-stand test with five repetitions
Key secondary outcomes
1. Motor function
Near tandem stand test, alternate step test
2. Cognitive function
Brief TMT-B, 3D cube copy
3. Questionnaires
home-based exercise self-efficacy, dietary variety score, GDS15, LSNS-6, and Kaigo yobou checklist)
4. Safety
The number of all adverse events that occur during the intervention period.
5. Adherence
Withdrawal/dropout rate.
Exercise participation rate on diary information.
Dietary variety score on diary information.
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
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
A comprehensive program consisting of exercise, nutrition, and social programs once a week, 60 min/time, for 8 weeks.
Interventions/Control_2
No treatment
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. older workers registered at employment dispatch centers
2. who have worked 4 days/month or more
3. who are able to provide informed consent.
Key exclusion criteria
1. who are restricted exercise by family doctors.
2. who have experienced angina or myocardial infarction, heart surgery within the last 3 months.
3. who have participated in the other observation survey
4. who have participated in the 10 times course frailty prevention class in the past
5. who are judged to be ineligible as a participant by a principal investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Osuka |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research Team for Promoting Independence and Mental Health
Zip code
173-0015
Address
35-2, Sakae-cho, Itabashi-ku, Tokyo
TEL
03-3964-3241
osuka@tmig.or.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Osuka |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research Team for Promoting Independence and Mental Health
Zip code
173-0015
Address
35-2, Sakae-cho, Itabashi-ku, Tokyo
TEL
03-3964-3241
Homepage URL
osuka@tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute of Gerontology
Institute
Department
Personal name
Funding Source
Organization
Japan Health Promotion & Fitness Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Tokyo Metropolitan Institute of Gerontology
Address
35-2, Sakae-cho, Itabashi-ku, Tokyo
Tel
03-3964-1141
rinsyoushiken@tmghig.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
| 2021 | Year | 06 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1002/1348-9585.12374
Number of participants that the trial has enrolled
69
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
Completed
Date of protocol fixation
| 2021 | Year | 06 | Month | 29 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2022 | 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
| 2021 | Year | 06 | Month | 29 | Day |
Last modified on
| 2023 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051062
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
