UMIN-CTR Clinical Trial

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
Email	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
Email	h.waki@thu.ac.jp

Sponsor
Institute	University of Tsukuba
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046408