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UMIN-CTR Clinical Trial |
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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 | 2021/01/03 |
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 |
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Condition | ||
Condition | Healthy athletes | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
alex.macznik@gmail.com |
Public contact | |||||||
Name of contact person |
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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/ | ||||||
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 |
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 |
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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 |
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Results Delayed | |||||||
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |