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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name