UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048833
Receipt number R000055645
Scientific Title Research on the occurrence and prevention of injuries in athletes
Date of disclosure of the study information 2022/09/02
Last modified on 2023/03/07 16:15:41

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Basic information

Public title

Research on the occurrence and prevention of injuries in athletes (focusing on nutrition, anemia, sleep, and locomotor function)

Acronym

Research on the occurrence and prevention of injuries in athletes

Scientific Title

Research on the occurrence and prevention of injuries in athletes

Scientific Title:Acronym

Research on the occurrence and prevention of injuries in athletes

Region

Japan


Condition

Condition

anemia, injuries

Classification by specialty

Medicine in general Surgery in general

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim is to investigate athletes' eating habits, sleep conditions, bone density, anemia, locomotory function, and injuries, and to propose improvement measures to improve performance.

Basic objectives2

Others

Basic objectives -Others

The aim was to investigate the eating habits, sleep conditions, bone density, anemia, locomotor function, and injury occurrence of Albirex Niigata male and female athletes and Niigata University of Health and Welfare designated club athletes, and to propose improvement measures to improve performance. do.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Dietary habits, sleep quality, anemia-related items

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

Eating habits, sleep, disability occurrence status, anemia-related index, and motor function evaluation are carried out once a year.

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

15 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

We asked people who have been doing high-intensity exercise for a long time to cooperate, and only those who agreed to cooperate with the survey were included.

Key exclusion criteria

Exclude those who have difficulty collecting blood.

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name Hiromi
Middle name
Last name Inaba

Organization

Niigata University of Health and Welfare

Division name

Faculty of Health Sciences,

Zip code

950-3198

Address

1398 Shimami-cho, Kita-ku, Niigata, Japan

TEL

0252574413

Email

inaba@nuhw.ac.jp


Public contact

Name of contact person

1st name Hiromi
Middle name
Last name Inaba

Organization

Niigata University of Health and Welfare

Division name

Faculty of Health Sciences

Zip code

950-3198

Address

1398 Shimami-cho, Kita-ku, Niigata, Japan

TEL

0252574413

Homepage URL


Email

inaba@nuhw.ac.jp


Sponsor or person

Institute

Faculty of Health Sciences, Niigata University of Health and Welfare

Institute

Department

Personal name



Funding Source

Organization

Japan Sports Agency, Ministry of education

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Niigata University of Health and Welfare

Address

1398 Shimami-cho, Kita-ku, Niigata, Japan

Tel

0252574413

Email

rinri@nuhw.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

2022 Year 09 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

Preinitiation

Date of protocol fixation

2022 Year 05 Month 25 Day

Date of IRB


Anticipated trial start date

2022 Year 09 Month 15 Day

Last follow-up date

2026 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

2022 Year 09 Month 02 Day

Last modified on

2023 Year 03 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055645


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name