UMIN-CTR Clinical Trial

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

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
URL(English)	https://upload.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

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