UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033273
Receipt number R000037821
Scientific Title The effect of an "injury risk reduction and performance enhancement" exercise program on biomechanics in female athletes - a cluster randomized controlled trial
Date of disclosure of the study information 2018/09/05
Last modified on 2021/01/03 20:22:19

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Basic information

Public title

The effect of an "injury risk reduction and performance enhancement" exercise program on biomechanics in female athletes - a cluster randomized controlled trial

Acronym

The effect of exercise program on biomechanics in female athletes

Scientific Title

The effect of an "injury risk reduction and performance enhancement" exercise program on biomechanics in female athletes - a cluster randomized controlled trial

Scientific Title:Acronym

The effect of exercise program on biomechanics in female athletes

Region

Japan


Condition

Condition

Healthy athletes

Classification by specialty

Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the effectiveness of exercise program in optimizing biomechanics in female athletes

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Lower limb kinetics and kinematics measured before and after the intervention

Key secondary outcomes

Lower limb strength


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

YES

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

12-weeks of exercises; at least 3 times per week, 15-30 minutes per session

Interventions/Control_2

No treatment, the athletes carry on with their usual training routine

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

12 years-old <

Age-upper limit

18 years-old >

Gender

Female

Key inclusion criteria

Healthy female athletes from Tokyo area
Participating in sports with prevalent pivoting and cutting tasks
Aged between 12 and 18 years (included)
Training at least 3 times per week

Key exclusion criteria

Not meet age or gender criteria
Train less than 3 times per week
Have an injury at the time of recruitment
Had a lower limb or back injury which required cessation of the physical activity for two weeks or longer within the previous six month
Have any condition or disease which would prevent them from participating in a high intensity (or maximal effort) physical activity
Had any surgery to lower limb or back
Had suffered an ACL injury before

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Aleksandra
Middle name Katarzyna
Last name Macznik

Organization

Keio University

Division name

Institute for Integrated Sports Medicine, School of Medicine

Zip code

160-8582

Address

Shinanomachi 35, Shinjuku-ku, Tokyo, JAPAN

TEL

0081333531211

Email

alex.macznik@gmail.com


Public contact

Name of contact person

1st name Aleksandra
Middle name Katarzyna
Last name Macznik

Organization

Keio University, School of Medicine

Division name

Institute for Integrated Sports Medicine, School of Medicine

Zip code

160-8582

Address

Shinanomachi 35, Shinjuku-ku, Tokyo, JAPAN

TEL

0081333531211

Homepage URL

https://alexmacznik.com/

Email

alex.macznik@gmail.com


Sponsor or person

Institute

Institute for Integrated Sports Medicine, School of Medicine, Keio University

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japanese


Other related organizations

Co-sponsor

Institute for Integrated Sports Medicine, School of Medicine, Keio University

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institute for Integrated Sports Medicine, School of Medicine, Keio University

Address

Shinanomachi 35, Shinjuku-ku, Tokyo, JAPAN

Tel

0081333531211

Email

alex.macznik@gmail.com


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

Keio University biomechanical laboratory (Tokyo)


Other administrative information

Date of disclosure of the study information

2018 Year 09 Month 05 Day


Related information

URL releasing protocol

https://www.sciencedirect.com/science/article/abs/pii/S1440244019310163?via%3Dihub

Publication of results

Unpublished


Result

URL related to results and publications

unpublished

Number of participants that the trial has enrolled

81

Results

unpublished

Results date posted

2021 Year 01 Month 03 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

unpublished

Participant flow

All participants finished the study.

Adverse events

No adverse events were noted.

Outcome measures

Unpublished

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2018 Year 06 Month 30 Day

Date of IRB

2018 Year 09 Month 04 Day

Anticipated trial start date

2018 Year 11 Month 01 Day

Last follow-up date

2019 Year 11 Month 26 Day

Date of closure to data entry

2020 Year 03 Month 01 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 07 Month 04 Day

Last modified on

2021 Year 01 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037821


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name