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Trial registered on ANZCTR
Registration number
ACTRN12607000590460
Ethics application status
Approved
Date submitted
14/11/2007
Date registered
16/11/2007
Date last updated
29/06/2012
Type of registration
Retrospectively registered
Titles & IDs
Public title
Peak torque and knee kinematics during gait after eccentric isokinetic training of quadriceps in healthy subjects
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Scientific title
Peak torque and knee kinematics during gait after eccentric isokinetic training of quadriceps in healthy subjects
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Knee Kinematics and Torque
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Condition category
Condition code
Musculoskeletal
2646
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0
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Normal musculoskeletal and cartilage development and function
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The bilateral isokinetic eccentric training (30º/s) of the knee extensors was: 3 set of 10 maximal contraction; 2 times a week for 6 weeks
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Intervention code [1]
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Prevention
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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The knee extensor torque in the nondominat limb was measured by isokinetic dynamometer before and after protocol training
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Assessment method [1]
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Timepoint [1]
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18 months
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Primary outcome [2]
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The flexion/extension and varus/valgus knee movements before and after training measured by electrogoniometer
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Assessment method [2]
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Timepoint [2]
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18 months
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Secondary outcome [1]
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The hamstrings/quadriceps (H:Q) ratio was calculed (hamstrings peak torque/quadriceps peak torque X 100) before and after protocol training
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Assessment method [1]
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Timepoint [1]
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18 months
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Eligibility
Key inclusion criteria
Healthy and active male subjects without any musculoskeletal injuries or symptoms or equilibrium disorders
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Minimum age
18
Years
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Maximum age
25
Years
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Sex
Males
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
No involved in other training program to improve the muscle force or knee pain
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
28/12/2004
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
25
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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Brazil
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State/province [1]
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Sao Carlos, SP
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Fundacao de Amparo a Pesquisa do Estado de Sao Paulo
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Address [1]
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Rua Pio XI, 1500 - Alto da Lapa, Sao Paulo, SP. CEP. 05468-901
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Country [1]
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Brazil
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Primary sponsor type
Individual
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Name
Heleodório Honorato dos Santos
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Address
Rua Alvarenga Peixoto, 331 apto 42 - Cidade Jardim - Sao Carlos, SP CEP. 13566-582
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Country
Brazil
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Secondary sponsor category [1]
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Individual
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Name [1]
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Tania de Fatima Salvini
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Address [1]
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Departamento de Fisioterapia
Rod. Washington Lu?s, km 235, Monjolinho, Sao Carlos, SP CEP. 13565-905
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Country [1]
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Brazil
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Comite de Etica em Pesquisas em Seres Humanos da Universidade Federal de Sao Carlos
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Ethics committee address [1]
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Pro-Reitoria de Pos-Graduacao da UFSCar Rod. Washington Lu?s, km 235, Monjolinho, Sao Carlos, SP CEP. 13560-970
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Ethics committee country [1]
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Brazil
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Date submitted for ethics approval [1]
4710
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Approval date [1]
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28/12/2004
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Ethics approval number [1]
4710
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144/04
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Summary
Brief summary
Changes in the gait pattern may occur as a consequence of joint tissue derangement, knee joint swelling, weakness of the quadriceps femoris muscle, or muscle inhibition due to pain. In a recent study11, where we applied eccentric isokinetic training of the quadriceps muscles in subjects submitted to anterior cruciate ligament (ACL) reconstruction, the knee extensor torque and flexion/extension range of motion during gait increased significantly after training. However, an unexpectedly increased valgus, most pronounced during the swing phase, as well as an increased valgus/varus range of motion, which may imply adverse effects on the knee, were also observed in the ACL reconstructed knee when compared with the healthy untrained knee. Hence, the mechanisms involved in the increased valgus, as well as its functional and clinical implications, needs clarification before eccentric training can be generally recommended for rehabilitation and sports activities. Thus, this study had the objective of evaluating the effects of eccentric isokinetic training on the strength of the extensor and flexor muscles of the knee, and the sagittal and coronal knee movements during gait, in healthy male subjects
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Trial website
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Trial related presentations / publications
SANTOS, HH; ÁVILA, MA; HANASHIRO, DN; CAMARGO, PR; SALVINI, TF. Efeitos do treino isocinético excêntrico dos extensores do joelho sobre a razão I/Q. XII Congresso Brasileiro de Biomecânica, Sao Pedro, SP, 2007.
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Prof. Dr. Tania de Fatima Salvini
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Address
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Departamento de Fisioterapia
Rod. Washington Luís, km 235, Monjolinho, Sao Carlos, SP CEP. 13565-905
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Country
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Brazil
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Phone
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+55 16 3351-8345
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Fax
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+55 16 3361-2081
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Email
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[email protected]
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Contact person for scientific queries
Name
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Prof. Dr. Tania de Fatima Salvini
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Address
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Departamento de Fisioterapia
Rod. Washington Luís, km 235, Monjolinho, Sao Carlos, SP CEP. 13565-905
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Country
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Brazil
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Phone
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+55 16 3351-8345
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Fax
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+55 16 3361-2081
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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