UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036875 |
|---|---|
| Receipt number | R000042021 |
| Scientific Title | Effects of exercise intervention at workplace on mental and physical health |
| Date of disclosure of the study information | 2019/05/28 |
| Last modified on | 2023/08/25 10:48:24 |
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Basic information
Public title
Effects of exercise intervention at workplace on mental and physical health
Acronym
Effects of exercise intervention at workplace on mental and physical health
Scientific Title
Effects of exercise intervention at workplace on mental and physical health
Scientific Title:Acronym
Effects of exercise intervention at workplace on mental and physical health
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of exercise intervention at workplace during lunch break or after work from the viewpoint of physical and mental health and work productivity
Basic objectives2
Others
Basic objectives -Others
To find the best way of exercise intervention for workers, especially university staff
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
physical and mental health and work productivity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
exercise
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
| 22 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Faculty staff working at university
Key exclusion criteria
People who are prohibited from exercising by doctor and cannot clear the PAR-Q (Physical Activity Readiness Questionnaire).
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | Ishiguro |
| Last name | Tanaka |
Organization
Nagoya University
Division name
Research Center of Health Physical Fitness and Sports
Zip code
4648601
Address
Furo-cho, Chikusa-ku, Nagoya, Aichi
TEL
0527893948
tanaka-n@htc.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | Ishiguro |
| Last name | Tanaka |
Organization
Nagoya University
Division name
Research Center of Health Physical Fitness and Sports
Zip code
4648601
Address
Furo-cho, Chikusa-ku, Nagoya, Aichi
TEL
0527893948
Homepage URL
tanaka-n@htc.nagoya-u.ac.jp
Sponsor or person
Institute
Research Center of Health Physical Fitness and Sports
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
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
Health and Sports Research Ethics Committee at Nagoya University
Address
Furo-cho, Chikusa-ku, Nagoya, Aichi
Tel
0527893946
hattori.nobuyuki@adm.nagoya-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
30-02
Org. issuing International ID_1
Health and Sports Research Ethics Committee at Nagoya University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 28 | Day |
Related information
URL releasing protocol
UMIN000036875
Publication of results
Published
Result
URL related to results and publications
https://www.htc.nagoya-u.ac.jp/research/%E7%B4%80%E8%A6%81/
Number of participants that the trial has enrolled
36
Results
In comparisons with Pre, irritability and total of work-related stress scores both significantly decreased at Post. Furthermore, changes in total physical activity between Pre and Post negatively correlated with changes in physical complaint scores. At Follow-up, body fat percentage also significantly decreased compared with Pre. The present results suggest that exercise interventions in the workplace relieve work-related stress and decrease body fat percentage.
Results date posted
| 2022 | Year | 05 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Among the faculty members working at national universities, those who have no restrictions on exercise implementation and have registered to participate in the exercise program held at the university.
Participant flow
We were able to obtain consent to participate in this study from 36 people. Of these, 6 dropouts and 10 research interruptions due to the pandemic of COVID-19. Finally, data analysis was conducted for 20 subjects.
Adverse events
None.
Outcome measures
Height, body weight, body fat percentage, waist circumference, and the thicknesses of abdominal skeletal muscle and subcutaneous fat, total physical activity, work-related stress
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 28 | Day |
Last modified on
| 2023 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042021
