UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052499 |
|---|---|
| Receipt number | R000059909 |
| Scientific Title | Study of the Effects of an Online Resistance Training Program in the Workplace on ME-BYO Index, Cognitive Function, and Work Engagement, and Research Toward Social Implementation of the Program |
| Date of disclosure of the study information | 2023/10/16 |
| Last modified on | 2024/06/11 16:57:40 |
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Basic information
Public title
Study of the Effects of an Online Resistance Training Program in the Workplace on ME-BYO Index, Cognitive Function, and Work Engagement, and Research Toward Social Implementation of the Program
Acronym
Research to verify the effectiveness of an online Resistance training program in the workplace and its social implementation
Scientific Title
Study of the Effects of an Online Resistance Training Program in the Workplace on ME-BYO Index, Cognitive Function, and Work Engagement, and Research Toward Social Implementation of the Program
Scientific Title:Acronym
Research to verify the effectiveness of an online Resistance training program in the workplace and its social implementation
Region
| Japan |
Condition
Condition
ME-BYO index
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the impact of an online group resistance training program on the feasibility of regular ME-BYO index measurement, ME-BYO index, health outcomes, work engagement, and implementation outcomes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ME-BYO index
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
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
An online group resistance training program will be conducted twice a week for 8 weeks. The ME-BYO index is self-measured before each program implementation.
Interventions/Control_2
The control group will measure the ME-BYO index by themselves twice a week in addition to the usual health guidance.
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
| 40 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Persons who are eligible for motivational support or active support in the specified health checkups
Those who do not have a habit of regular resistance training at least twice a week.
Key exclusion criteria
Persons who cannot obtain informed consent from the person regarding the contents of the consent confirmation document.
The person who has difficulty filling out the questionnaire.
Those who have difficulty communicating in Japanese.
Those who judge that it is inappropriate to implement an intervention program in view of physical and psychological burdens.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshinobu |
| Middle name | |
| Last name | Saito |
Organization
Nippon Sport Science University
Division name
Faculty of Sport Management
Zip code
227-0033
Address
1221-1 Kamoshida-cho, Aoba-ku, Yokohama, Kanagawa
TEL
045-963-7900
ysaito@nittai.ac.jp
Public contact
Name of contact person
| 1st name | Yoshinobu |
| Middle name | |
| Last name | Saito |
Organization
Nippon Sport Science University
Division name
Faculty of Sport Management
Zip code
227-0033
Address
1221-1 Kamoshida-cho, Aoba-ku, Yokohama, Kanagawa
TEL
045-963-7900
Homepage URL
ysaito@nittai.ac.jp
Sponsor or person
Institute
Nippon Sport Science University
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of the Nippon Sport Science University
Address
7-1-1 Fukasawa, Setagaya-ku, Tokyo
Tel
03-5706-0931
souspo@nittai.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
| 2023 | Year | 10 | Month | 16 | 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
19
Results
The study was changed to a single-arm design due to low enrollment of those who met the selection criteria during the recruitment period.
Results date posted
| 2024 | Year | 06 | Month | 11 | Day |
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 | 06 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 10 | Month | 14 | Day |
Last modified on
| 2024 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059909
