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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033273
Receipt No. 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 2020/03/02

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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
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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 81
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 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
2020 Year 03 Month 02 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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