UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060211 |
|---|---|
| Receipt number | R000068840 |
| Scientific Title | The effect of a physical activity program on loneliness among workers: a randomized controlled trial |
| Date of disclosure of the study information | 2025/12/26 |
| Last modified on | 2025/12/26 11:40:21 |
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Basic information
Public title
The effect of a physical activity program on loneliness among workers
Acronym
The effect of a physical activity program on loneliness among workers
Scientific Title
The effect of a physical activity program on loneliness among workers: a randomized controlled trial
Scientific Title:Acronym
The effect of a physical activity program on loneliness among workers: a randomized controlled trial
Region
| Japan |
Condition
Condition
Loneliness
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of the physical activity program on improving loneliness among workers by a randomized controlled trial design.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Loneliness (UCLA Loneliness Scale)(Immediately after intervention, one month after intervention)
Key secondary outcomes
Psychological distress(K6)
Physical complaint(BJSQ)
Workplace social capital(Workplace social capital scale)
Social support (BJSQ)
Work engagement(UWES)
Work performance and Absenteeism(WHO-HPQ)
Exercise self-efficacy(Exercise self-efficacy scale)
Exercise habit
Loneliness at work (Scale for loneliness at work)
Loneliness (The three-item loneliness scale)
(Only intervention group)
Implementation outcome
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
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
A physical activity program consisting of approximately eight 30-minute sessions will be offered to workers over one month.
Interventions/Control_2
Waitlist
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Workers
Key exclusion criteria
Those with persistent dizziness.
Those who have been advised by a physician to restrict physical activity.
Target sample size
128
Research contact person
Name of lead principal investigator
| 1st name | Asuka |
| Middle name | |
| Last name | Sakuraya |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Digital Mental Health
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5800-9621
asuka@m.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Asuka |
| Middle name | |
| Last name | Sakuraya |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Digital Mental Health
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5800-9621
Homepage URL
asuka@m.u-tokyo.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, The University of Tokyo
Institute
Department
Personal name
Asuka Sakuraya
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research ethics committee, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-0033, JAPAN
Tel
03-5841-0818
ethics@m.u-tokyo.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 | 12 | Month | 26 | 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 | 11 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2025 | Year | 12 | Month | 26 | Day |
Last modified on
| 2025 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068840
