UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061362 |
|---|---|
| Receipt number | R000070207 |
| Scientific Title | A single-group pre-post intervention study examining the effects of sustained practice of the Square-Stepping Exercise program on stress perception, mental health status, and health behaviors among participants in a Public Health Lecture for Citizens |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/04/23 15:44:41 |
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Basic information
Public title
Changes in Stress Perception and Health Behaviors through Continued Practice of Square-Stepping Exercise in a Public Health Lecture for Citizens
Acronym
Square Step Public Lecture Study
Scientific Title
A single-group pre-post intervention study examining the effects of sustained practice of the Square-Stepping Exercise program on stress perception, mental health status, and health behaviors among participants in a Public Health Lecture for Citizens
Scientific Title:Acronym
SSE Pre-Post Study
Region
| Japan |
Condition
Condition
Not applicable (health promotion for community-dwelling adults)
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine pre-post changes in stress perception, mental well-being, and health behaviors among participants through approximately three months of continued square-stepping exercise practice after a public health lecture. It also aims to assess adherence to home-based practice and to obtain basic data on the usefulness of a community-based health promotion program.
Basic objectives2
Others
Basic objectives -Others
Evaluation of the feasibility and usefulness of a citizen-oriented health promotion program combining health education and exercise practice
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Participant Overview: (1) Gender, (2) Age, (3) Employment Status, (4) Presence of Co-residing Family Members, (5) Current Medical History, (6) Presence of Physical Limitations
2. Changes in Customized Items Regarding Stress Perception
3. Psychological Distress: Changes in K6 Japanese Version Scores
4. Mental Health Status: Changes in WHO-5 Japanese Version Scores
5. Changes in Items Related to Physical Activity and Health Behaviors
6. Confidence in Continuing the Square-Stepping Exercise program and Intentions to Incorporate It into Daily Life
Key secondary outcomes
1. Changes in perceived health
2. Course satisfaction
3. Open-ended comments regarding course participation and continued practice
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants will attend the first session of a public health lecture, which includes a lecture on mental and physical health and practical instruction in square-stepping exercise. They will then be encouraged to continue square-stepping exercise at home within a safe and manageable range for approximately three months. At the second session, adherence will be assessed, additional education will be provided, the exercise will be reviewed, and follow-up questionnaires will be administered.
Interventions/Control_2
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
1.Individuals who have participated in the Mental and Physical Wellness Seminar, a public lecture series held at Shimonoseki City University
2.Individuals aged 18 or older
3.Individuals who have understood the study explanation and provided written consent
Key exclusion criteria
1.Individuals who have difficulty understanding the study or giving informed consent even after receiving an explanation
2. Individuals deemed unable to participate in the course due to illness or other health issues
3. Individuals deemed unable to perform the Square Step for safety reasons
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yukiko |
| Middle name | |
| Last name | Matsumura |
Organization
Shimonoseki City University
Division name
Faculty of Nursing
Zip code
7510831
Address
2-3-17, Daigakucho, Shimonoseki-shi, Yamaguchi, Japan
TEL
083-252-0288
matsumura-yu@shimonoseki-cu.ac.jp
Public contact
Name of contact person
| 1st name | Yukiko |
| Middle name | |
| Last name | Matsumura |
Organization
Shimonoseki City University
Division name
Faculty of Nursing
Zip code
7510831
Address
2-3-17, Daigakucho, Shimonoseki-shi, Yamaguchi, Japan
TEL
0832520288
Homepage URL
matsumura-yu@shimonoseki-cu.ac.jp
Sponsor or person
Institute
Shimonoseki City University
Institute
Department
Personal name
Funding Source
Organization
Shimonoseki City University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shimonoseki City University Research Ethics Review Committee
Address
2-1-1, Daigakucho, Shimonoseki-shi, Yamaguchi, Japan
Tel
083-252-0288
kenkyurinri@shimonoseki-cu.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 | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 21 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2028 | 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 | 04 | Month | 23 | Day |
Last modified on
| 2026 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070207
