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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004438
Receipt No. R000004986
Scientific Title Evaluation of cardio-respiratory fitness among athletes undergoing surgical repair of anterior crossed ligament
Date of disclosure of the study information 2010/10/25
Last modified on 2015/04/25

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Basic information
Public title Evaluation of cardio-respiratory fitness among athletes undergoing surgical repair of anterior crossed ligament
Acronym Cardio-respiratory fitness evaluation for sport-rehabilitation
Scientific Title Evaluation of cardio-respiratory fitness among athletes undergoing surgical repair of anterior crossed ligament
Scientific Title:Acronym Cardio-respiratory fitness evaluation for sport-rehabilitation
Region
Japan

Condition
Condition Anterior Crossed ligament injury
Classification by specialty
Medicine in general Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate cardio-respiratory fitness in athletes before and after surgical repair of anterior crossed ligament
Basic objectives2 Others
Basic objectives -Others Evaluation
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Maximal oxygen uptake
Key secondary outcomes Body composition
Muscle power

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
15 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria Patients engaging regular sport-activity, who require surgical repair of anterior crossed ligament
Key exclusion criteria Anemic patients
Pregnant women
Target sample size 20

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Koichiro Azuma
Organization School of Medicine, Keio University
Division name Institute for Integrated Sports Medicine
Zip code
Address 35 Shinanomachi, Shinjuku, Tokyo, Japan
TEL
Email

Public contact
1st name of contact person
1st name
Middle name
Last name
Organization School of Medicine, Keio University
Division name Institute for Integrated Sports Medicine
Zip code
Address 35 Shinanomachi, Shinjuku, Tokyo, Japan
TEL
Homepage URL
Email

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

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2010 Year 10 Month 25 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
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
2010 Year 07 Month 26 Day
Date of IRB
Anticipated trial start date
2010 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Evaluation of maximal oxygen uptake and body composition before and about 8weeks after ACL surgical repair

Management information
Registered date
2010 Year 10 Month 25 Day
Last modified on
2015 Year 04 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004986

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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