UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062419 |
|---|---|
| Receipt number | R000071433 |
| Scientific Title | Efficacy of Exercise Interventions by Certified Health Exercise Professionals in Health and Productivity Management: A Quasi-Randomized Parallel-Group Comparative Trial |
| Date of disclosure of the study information | 2026/07/31 |
| Last modified on | 2026/07/31 13:02:43 |
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Basic information
Public title
Evaluation of Exercise Programs Provided by Certified Exercise Professionals in Health and Productivity Management
Acronym
Health and Productivity Management - Exercise
Scientific Title
Efficacy of Exercise Interventions by Certified Health Exercise Professionals in Health and Productivity Management: A Quasi-Randomized Parallel-Group Comparative Trial
Scientific Title:Acronym
Health and Productivity Management - Exercise Trainer Trial
Region
| Japan |
Condition
Condition
Healthy working adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to epidemiologically evaluate the efficacy of exercise interventions provided by certified health exercise professionals compared to information provision alone (control group) on improving quality of life (QOL) and physical function among employees in occupational health settings. This study aims to provide foundational evidence for establishing a sustainable intervention model and clarifying the role of exercise professionals in Health and Productivity Management.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary Outcome:
Health-Related Quality of Life (SF-36v2 Japanese version)
Outcome Details / Measurement Method:
Health-related quality of life measured by the SF-36v2 Japanese version. The outcome includes eight subscales (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health) and three summary scores (Physical Component Summary [PCS], Mental Component Summary [MCS], and Role Component Summary [RCS]).
Time Point(s):
Baseline and 4 months post-baseline (at the end of the intervention period)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Face-to-face physical activity and exercise instruction provided by certified health exercise professionals
Interventions/Control_2
Provision of health and exercise information only, without face-to-face instruction
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Full-time or part-time employees aged 18 years or older working at the participating companies
2. Individuals who understand the purpose of the study and provide written informed consent
3. Individuals who are able to attend regular exercise sessions during intervention period
Key exclusion criteria
1. Individuals with medical contraindications to exercise as determined by a physician
2. Individuals instructed to restrict physical activity by a primary physician or occupational physician
3. Individuals anticipated to have difficulty completing the 4-month program due to job requirements, injury, or illness
4. Individuals unable to properly complete self-administered questionnaires (e.g., SF-36) due to cognitive impairment or other reasons
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Akihiko |
| Middle name | |
| Last name | Katayama |
Organization
Shikoku Gakuin University
Division name
Faculty of Sociology
Zip code
765-8505
Address
3-2-1, Bunkyocho, Zentsuji-shi, Kagawa, Japan
TEL
0877-62-2111
kata@sg-u.ac.jp
Public contact
Name of contact person
| 1st name | Akihiko |
| Middle name | |
| Last name | Katayama |
Organization
Shikoku Gakuin University
Division name
Faculty of Sociology
Zip code
765-8505
Address
3-2-1, Bunkyocho, Zentsuji-shi, Kagawa, Japan
TEL
0877-62-2111
Homepage URL
kata@sg-u.ac.jp
Sponsor or person
Institute
Shikoku Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Japan Health Promotion & Fitness Foundation
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shikoku Gakuin University
Address
3-2-1, Bunkyocho, Zentsuji-shi, Kagawa, Japan
Tel
0877-62-2111
kata@sg-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
| 2026 | Year | 07 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 07 | Month | 31 | Day |
Last modified on
| 2026 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071433
