UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040671
Receipt number R000046407
Scientific Title The association between dynamic alignment and injury occurrence in college football players
Date of disclosure of the study information 2020/09/23
Last modified on 2021/12/24 10:15:24

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Basic information

Public title

The association between dynamic alignment and injury occurrence in college football players

Acronym

The association between dynamic alignment and injury occurrence in college football players

Scientific Title

The association between dynamic alignment and injury occurrence in college football players

Scientific Title:Acronym

The association between dynamic alignment and injury occurrence in college football players

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 dynamic alignment associates with injury occurrence in college football players.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The incidence of sports injuries

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Collective exercise(1 year)

Interventions/Control_2

Control

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
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 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

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

2020 Year 09 Month 23 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

2021 Year 04 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



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=R000046407


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name