UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040925 |
|---|---|
| Receipt number | R000046471 |
| Scientific Title | Effects of online exercise programs during self-restraint on physical condition and mood: A practical study in students, faculty and staff |
| Date of disclosure of the study information | 2020/07/01 |
| Last modified on | 2021/01/07 14:23:34 |
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Basic information
Public title
STAY ACTIVE PROJECT
Acronym
STAY ACTIVE PROJECT
Scientific Title
Effects of online exercise programs during self-restraint on physical condition and mood: A practical study in students, faculty and staff
Scientific Title:Acronym
Effects of online exercise programs during self-restraint on physical condition and mood
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to elucidate the effects of online exercise programs during self-restraint on physical condition and mood.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
physical condition and mood (for students)
work ability in addition to physical condition and mood (for faculty and staff)
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
online exercise programs
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
students, faculty and staff in the university
Key exclusion criteria
NA
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Mayumi |
| Middle name | |
| Last name | Nagano |
Organization
Fukuoka Women's University
Division name
International College of Arts and Sciences
Zip code
813-8529
Address
1-1-1 Kasumigaoka, Higashi-ku, Fukuoka city
TEL
092-661-2411
m-nagano@fwu.ac.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Ohta |
Organization
Fukuoka Women's University
Division name
International College of Arts and Sciences
Zip code
813-8529
Address
1-1-1 Kasumigaoka, Higashi-ku, Fukuoka city
TEL
092-661-2411
Homepage URL
m-ohta@fwu.ac.jp
Sponsor or person
Institute
Fukuoka Women's University
Institute
Department
Personal name
Funding Source
Organization
Fukuoka Women's 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
Business Management Center
Address
1-1-1 Kasumigaoka, Higashi-ku, Fukuoka City
Tel
092-661-2411
soumu@fwu.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
| 2020 | Year | 07 | 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
244
Results
(1) Sedentary time among the students was 10 hours/day in average.
(2) The students with more indefinite complaints had less favorable lifestyle, longer sedentary time, and less ability to cope with stress.
(3) The longer the students took part in the video sessions, the greater the improvement in indefinite complaints.
Results date posted
| 2021 | Year | 01 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Students in one university
Participant flow
Voluntary participation
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 05 | Day |
Date of closure to data entry
| 2020 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 28 | Day |
Last modified on
| 2021 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046471
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
