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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044706
Receipt No. 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 2021/06/29

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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
Email 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
Email osuka@tmig.or.jp

Sponsor
Institute Tokyo Metropolitan Institute of Gerontology
Institute
Department

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
Email 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 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
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
2021 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.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
Registered date File name


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