UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058920 |
|---|---|
| Receipt number | R000067386 |
| Scientific Title | An Exploratory Study on the Effects of Office-Based Exercise Interventions on Workers' Health Behaviors |
| Date of disclosure of the study information | 2025/09/01 |
| Last modified on | 2025/08/28 18:43:01 |
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Basic information
Public title
An Exploratory Study on the Effects of Office-Based Exercise Interventions on Workers' Health Behaviors
Acronym
An Exploratory Study of the Effects of Office Exercise Interventions
Scientific Title
An Exploratory Study on the Effects of Office-Based Exercise Interventions on Workers' Health Behaviors
Scientific Title:Acronym
An Exploratory Study of the Effects of Office Exercise Interventions
Region
| Japan |
Condition
Condition
Physical inactivity
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the effects of an exercise intervention tailored for office workers (office-based exercise intervention) on the behavioral change stages of workers' exercise habits and on health behaviors.
Basic objectives2
Others
Basic objectives -Others
To explore the effects of an exercise intervention tailored for office workers (office-based exercise intervention) on the behavioral change stages of workers' exercise habits and on health behaviors.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Stages of behavioral change in exercise habits at baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention
Key secondary outcomes
Pre-intervention (baseline), at the end of the 3-month intervention, and 3 months after the intervention ended:
-Daily step count
-Mets during work (light, moderate, vigorous, moderate-to-vigorous)
-Mets during daily life (light, moderate, vigorous, moderate-to-vigorous)
-Prolonged sedentary time during work
-Prolonged sedentary time during daily life
Subjective health assessment
-Self-reported symptoms: shoulder stiffness, lower back pain, body stiffness, eye fatigue, headache
-Japanese version of the Somatic Symptom Scale (SSS-8)
Mental health measures
-Non-specific stress indicator: Kessler 6-Item Psychological Distress Scale (K6)
Work engagement
-Japanese version of the Utrecht Work Engagement Scale
-Japanese version of the WHO Work and Work Performance Questionnaire
Qualitative analysis via group interviews
Barriers to health behaviors
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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
ASPO inc. delivers interventions through a comprehensive program composed of its proprietary content. Each intervention session lasts approximately 15 minutes, with participants completing one exercise session per week over 12 weeks.
In-person program (specialized trainers visit corporate offices to provide instruction)
- Refresh exercises within the office
- Light resistance training within the office
- Health behavior awareness activities (workshop format)
- Physical fitness performance assessment
- Personalized guidance
Online Program (supplementary method when in-person sessions are not feasible)
- On-demand exercise content
- Real-time online refresh sessions (trainer-led)
- Online personal guidance
- Online health behavior awareness activities (workshop format)
Interventions/Control_2
The control group will not receive exercise instruction or related information during the intervention 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
For individuals
- Individuals who are adults at the time consent is obtained
- Individuals who have provided consent to participate in the study
For clusters
- Clusters must be able to secure 25 participants within the same company prior to the start of the intervention.
- Intervention group clusters must be able to secure an environment (space, etc.) where office-based exercise can be conducted.
Key exclusion criteria
For individuals
- Individuals for whom exercise is contraindicated (discontinued by physician)
- Individuals unable to complete at least one-third of the exercise intervention due to extended business trips exceeding one month during the intervention period
- Pregnant women or those who may be pregnant
- Individuals unable to continue the exercise for any reason
- Other individuals deemed unsuitable by the principal investigator or co-investigators
For clusters
- Clusters cannot secure 25 participants within the same company prior to intervention commencement.
- Intervention group clusters cannot secure an environment (space, etc.) suitable for implementing office-based exercise programs.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Nakata |
Organization
Graduate School of Medicine, The University of Osaka
Division name
Department of Health and Sport Sciences
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka
TEL
06-6210-8439
ogasawara.issei.med@osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Issei |
| Middle name | |
| Last name | Ogasawara |
Organization
Graduate School of Medicine, The University of Osaka
Division name
Department of Health and Sport Sciences
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka
TEL
06-6210-8439
Homepage URL
ogasawara.issei.med@osaka-u.ac.jp
Sponsor or person
Institute
The University of Osaka
Institute
Department
Personal name
Ken Nakata
Funding Source
Organization
Japan Sports Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Osaka Hospital Ethical Review Board
Address
2-2 Yamadaoka, Suita, Osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-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
| 2025 | Year | 09 | Month | 01 | 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
| 2025 | Year | 08 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2027 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2027 | Year | 12 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 28 | Day |
Last modified on
| 2025 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067386
