UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the effects of online-based workplace exercise program for remote workers
Acronym	Evaluation of the effects of online-based workplace exercise program
Scientific Title	Effects of online-based workplace exercise program on work-related indicators for remote workers: A cluster non-randomized controlled trial
Scientific Title:Acronym	Effects of online-based workplace exercise program on work-related indicators
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to clarify the effects of online-based workplace exercise program on work-related indicators among remote workers.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Work engagement before and after the exercise program
Key secondary outcomes	Collective efficacy, body pain, social support, recovery experience, organizational commitment, job satisfaction, loneliness, working memory, perception for workplace exercise (before and after the exercise program) Physical activity, sedentary behavior, communication, work performance, sleepiness during working time (during the exercise program)

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	The exercise program will be conducted on an online system three times per week for three weeks. Each session will be conducted for 30 min by experienced exercise instructor. The main exercises of the program will be yoga, stretching exercise, and recreational activities.
Interventions/Control_2	The control group will receive no treatment during the exercise program period.
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	20 years-old <=
Age-upper limit	50 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Workers who are working from home. 2) Those who do not have any exercise restrictions from a doctor. 3) Those who do not have any concerns regarding safety for participating the workplace exercise program based on the Physical Activity Readiness Questionnaire (PAR-Q).
Key exclusion criteria	In the case that the participant is expected to be difficult to continue to participate the program due to human resource reasons such as resignation.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Yuko Middle name Last name Kai
Organization	Meiji Yasuda Life Foundation of Health and Welfare
Division name	Physical Fitness Research Institute
Zip code	192-0001
Address	Tobuki 150, Hachioji, Tokyo 192-0001, Japan
TEL	042-691-1163
Email	y-kai@my-zaidan.or.jp

Public contact
Name of contact person	1st name Takashi Middle name Last name Jindo
Organization	Meiji Yasuda Life Foundation of Health and Welfare
Division name	Physical Fitness Research Institute
Zip code	192-0001
Address	Tobuki 150, Hachioji, Tokyo 192-0001, Japan
TEL	042-691-1163
Homepage URL
Email	ta-jindo@my-zaidan.or.jp

Sponsor
Institute	Information Services International-Dentsu, LTD
Institute
Department

Funding Source
Organization	Self-funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Information Services International-Dentsu, LTD
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Meiji Yasuda Life Foundation of Health and Welfare
Address	Tobuki 150, Hachioji, Tokyo 192-0001, Japan
Tel	042-691-1163
Email	yoshida@my-zaidan.or.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	株式会社電通国際情報サービス Information Services International-Dentsu, LTD

Other administrative information
Date of disclosure of the study information	2020 Year 09 Month 09 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	Completed
Date of protocol fixation	2020 Year 08 Month 11 Day
Date of IRB	2020 Year 09 Month 07 Day
Anticipated trial start date	2020 Year 09 Month 16 Day
Last follow-up date	2020 Year 10 Month 31 Day
Date of closure to data entry	2020 Year 12 Month 01 Day
Date trial data considered complete	2020 Year 12 Month 28 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 09 Month 09 Day
Last modified on	2021 Year 03 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047640