UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040672 |
|---|---|
| Receipt number | R000046408 |
| Scientific Title | Effects of activity restriction associated with COVID-19 on the physical and mental health of college athletes |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2021/12/24 10:14:24 |
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Basic information
Public title
Effects of activity restriction associated with COVID-19 on the physical and mental health of college athletes
Acronym
Effects of activity restriction associated with COVID-19 on the physical and mental health of college athletes
Scientific Title
Effects of activity restriction associated with COVID-19 on the physical and mental health of college athletes
Scientific Title:Acronym
Effects of activity restriction associated with COVID-19 on the physical and mental health of college athletes
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study aimed to investigate whether the physical and mental health could be affected by the activity restriction associated with COVID -19 in college football players.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
depression
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 25 | years-old | > |
Gender
Male
Key inclusion criteria
Players on the college football team
Players taking part in the training
Key exclusion criteria
Athletes who are expected to be out of competition for more than one year
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Masaaki |
| Middle name | Waki |
| Last name | Koido |
Organization
University of Tsukuba
Division name
Faculty of Health and Sports Science
Zip code
305-8574
Address
1-1-1 tennoudai, tsukuba-shi, ibaraki
TEL
029-853-2664
koido.masaaki.gu@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Waki |
Organization
University of Teikyoheise Faculty of Health Care
Division name
Department of acupuncture and Moxibustion.
Zip code
170-8445
Address
2-51-4 Higashi-ikebukuro, Toshima-ku, Tokyo, Japan.
TEL
03-5843-3111
Homepage URL
h.waki@thu.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Teikyo Heisei 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
Teikyo Heisei University
Address
2-51-4 Higashi-ikebukuro, Toshima-ku, Tokyo, Japan.
Tel
03-5843-3111
rec@thu.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
| 2021 | Year | 04 | 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
160
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
Completed
Date of protocol fixation
| 2019 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation period: from March 2020 to June 2020
Management information
Registered date
| 2020 | Year | 06 | Month | 06 | Day |
Last modified on
| 2021 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046408
