UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057602 |
|---|---|
| Receipt number | R000065759 |
| Scientific Title | The effect of providing exercise spaces in the workplace on the physical activity levels of working women: Randomized,open-label, parallel-group comparison trial |
| Date of disclosure of the study information | 2025/04/15 |
| Last modified on | 2026/05/07 14:36:10 |
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Basic information
Public title
The effect of providing exercise spaces in the workplace on the physical activity levels of working women
Acronym
The effect of providing exercise spaces in the workplace on the physical activity levels of working women
Scientific Title
The effect of providing exercise spaces in the workplace on the physical activity levels of working women: Randomized,open-label, parallel-group comparison trial
Scientific Title:Acronym
The effect of providing exercise spaces in the workplace on the physical activity levels of working women: Randomized,open-label, parallel-group comparison trial
Region
| Japan |
Condition
Condition
Women aged 18 to 64 years engaged in desk work, capable of normal walking
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of providing exercise spaces in the workplace on physical activity of working women aged 18-64 years old who are engaged in desk work.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in number of steps over 3 METs during work hours from baseline to 4 weeks after providing exercise spaces in the workplace.
Key secondary outcomes
The evaluation of the following items 1 to 12 will be based on data from the baseline and 4 weeks after providing the exercise space.
1. Percentage change in the number of steps with at least 3 METs during working hours.
2. Change in the total number of steps and percentage change in total steps during working hours.
3. Change in sedentary time(minutes).
4. Percentage improvement in exercise habits.
5. Percentage improvement in awareness regarding exercise.
6. Change in body composition values(muscle mass, regional muscle mass, body fat mass, body fat percentage, and skeletal muscle index)
7. Total score and the change in the total score of the short-form DRSP.
8. Total score and change in the total score of the Simplified Menopausal Index.
9. Total score and change in the total score of the Pittsburgh Sleep Quality Index.
10.Percentage improvement in dietary habits(frequency of balanced meals with staple foods, main dishes, and side dishes; consumption of sugary drinks and snacks).
11.Percentage of participants selecting specific types of footwear during work.
12.Most used exercise equipment.
The evaluation of items 13 and 14 will be based on data from the baseline and 2 weeks after providing the exercise space.
13.Change in the number of steps with at least 3 METs during working hours and percentage change.
14.Change in total steps during working hours and percentage change.
The following item will be evaluated from the step count survey to 4 weeks after providing the exercise space.
15.Adverse events.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
Providing exercise space in the workplace for 4 weeks and encourage its use
Interventions/Control_2
Living a normal lifestyle for 4 weeks
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
| 64 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Participants employed at facilities that provided consent to participate in this study.
2.Participants whose daily working hours are at least 6 hours and who perform office tasksusing information devices(e.g., desktop computers, laptop computers, tablets, smartphones)for at least 4 hours.
3.Participants who are able to walk and exercise at intensity of at least 3 METs.
4.Participants who are able to wear a physical activity monitor (pedometer) while working.
5.Participants who wore a physical activity monitor for at least 6 hours during working hours in the baseline survey, and were able to accumulate step count data for at least 3 days.
6.Participants who have provided written informed consent to participate in this study, after receiving sufficient explanation regarding the study.
Key exclusion criteria
1.Participants who are currently receiving outpatient treatment for a disease and have been explicitly prohibited from exercising by a physician.
2.Participants whose blood pressure or blood glucose levels meet the following criteria based on the results of a health check conducted in the past year.
.Participants whose systolic blood pressure is 180mmHg or higher and/or diastolic blood pressure is 110mmHg or higher.
.Participants whose fasting blood glucose level is 250mg/dl or higher.
3.Participants who are pregnant, may be pregnant, or intend to become pregnant during the study, or those who are breastfeeding.
4.Participants who have an implantable medical device such as a cardiac pacemaker.
5.Participants who have a systolic blood pressure of 180mmHg or higher and/or a diastolic blood pressure of 110mmHg or higher at the time of obtaining consent.
6.Participants who have participated in other clinical trials(including clinical trials of investigational drugs)and have received a test drug within 4 weeks prior to the start of the study.
7.Participants who are judged unsuitable for this study by the principal investigator or subinvestigators.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shotaro |
| Middle name | |
| Last name | Taniguchi |
Organization
Miyazaki Prefectural Health Foundation
Division name
Health Promotion Department
Zip code
880-0032
Address
1-1-2 Kirishima, Miyazaki-shi, Miyazaki
TEL
0985-27-2684
suisin-center_21@miyakenkou.or.jp
Public contact
Name of contact person
| 1st name | Wakako |
| Middle name | |
| Last name | Taguchi |
Organization
Miyazaki Prefectural Health Foundation
Division name
Health Promotion Department
Zip code
880-0032
Address
1-1-2 Kirishima, Miyazaki-shi, Miyazaki
TEL
0985-27-2684
Homepage URL
suisin-center_21@miyakenkou.or.jp
Sponsor or person
Institute
Miyazaki Prefectural Health Foundation
Institute
Department
Personal name
Funding Source
Organization
Miyazaki Prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Health Care Research, Organization for Promotion of Research and Industry-Academic Regional Collaboration, University of Miyazaki (Kiyotake Branch)
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of University of Miyazaki
Address
Kihara 5200, Kiyotake, Miyazaki 889-1692, Japan
Tel
0985-85-9010
igakubu_kenkyu@med.miyazaki-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 | 04 | Month | 15 | 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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 02 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 30 | 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
| 2025 | Year | 04 | Month | 14 | Day |
Last modified on
| 2026 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065759
