UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054845 |
|---|---|
| Receipt number | R000062630 |
| Scientific Title | An effect of exercise support using wearable devices on presenteeism. |
| Date of disclosure of the study information | 2024/07/02 |
| Last modified on | 2024/12/31 22:09:36 |
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Basic information
Public title
An effect of exercise support using wearable devices on presenteeism.
Acronym
An effect of exercise support using wearable devices on presenteeism.
Scientific Title
An effect of exercise support using wearable devices on presenteeism.
Scientific Title:Acronym
An effect of exercise support using wearable devices on presenteeism.
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate whether exercise support using wearable devices is effective in improving presenteeism in workers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in the Japanese version of the WLQ
Key secondary outcomes
1. Prediction estimation model for WLQ improvement
2. Changes before and after intervention (Patient Health Questionnare-9 (PHQ-9), new version of STAI state-trait anxiety test)
3. Changes before and after intervention (Patient Health Questionnare-9 (PHQ-9), new version of STAI state-trait anxiety test, step count, heart rate variability)
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
| Behavior,custom |
Interventions/Control_1
After obtaining consent to participate, participants respond to several questionnaire(WLG,Patient Health Questionnare-9 (PHQ-9), new version of STAI state-trait anxiety test). Participants wear Apple Watch on a daily basis, and exercise daily in a defined exercise regime.
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.People over 18 years old using Apple Watch
2.Employees of Nissin Foods Group in Japan
3.Those who fully understood the purpose of this study and agreed to participate in this study.
Key exclusion criteria
1.Persons judged by the research director or co-investigator to be unsuitable for this study.
2.Persons with comorbidities that prevent exercise training.
3.Persons who have been instructed by a doctor to restrict exercise.
4.Those who have difficulty in daily exercise due to chronic back pain, knee pain, etc.
5.Those who have depression or mental illness and have difficulty getting enough exercise.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Katsumata |
| Middle name | |
| Last name | Yoshinori |
Organization
Keio University
Division name
School of Medicine, Institute for Integrated Sports Medicine
Zip code
160-0016
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 Japan
TEL
03-5269-9054
goodcentury21@keio.jp
Public contact
Name of contact person
| 1st name | Katsumata |
| Middle name | |
| Last name | Yoshinori |
Organization
Keio University
Division name
School of Medicine, Institute for Integrated Sports Medicine
Zip code
160-0016
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 Japan
TEL
03-5269-9054
Homepage URL
goodcentury21@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Nissin Foods Holdings Co., Ltd.
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
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 Japan
Tel
03-5363-3503
med-rinri-jimu@adst.keio.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
| 2024 | Year | 07 | Month | 02 | 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
| 2024 | Year | 06 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | 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
| 2024 | Year | 07 | Month | 02 | Day |
Last modified on
| 2024 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062630
