Trial Review

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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
Scientific title
Peak torque and knee kinematics during gait after eccentric isokinetic training of quadriceps in healthy subjects
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Kinematics and Torque 2546 0
Condition category
Condition code
Musculoskeletal 2646 2646 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 2278 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3556 0
The knee extensor torque in the nondominat limb was measured by isokinetic dynamometer before and after protocol training
Timepoint [1] 3556 0
18 months
Primary outcome [2] 3557 0
The flexion/extension and varus/valgus knee movements before and after training measured by electrogoniometer
Timepoint [2] 3557 0
18 months
Secondary outcome [1] 5955 0
The hamstrings/quadriceps (H:Q) ratio was calculed (hamstrings peak torque/quadriceps peak torque X 100) before and after protocol training
Timepoint [1] 5955 0
18 months

Eligibility
Key inclusion criteria
Healthy and active male subjects without any musculoskeletal injuries or symptoms or equilibrium disorders
Minimum age
18 Years
Maximum age
25 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
No involved in other training program to improve the muscle force or knee pain

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/12/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment outside Australia
Country [1] 653 0
Brazil
State/province [1] 653 0
Sao Carlos, SP

Funding & Sponsors
Funding source category [1] 2791 0
Government body
Name [1] 2791 0
Fundacao de Amparo a Pesquisa do Estado de Sao Paulo
Country [1] 2791 0
Brazil
Primary sponsor type
Individual
Name
Heleodório Honorato dos Santos
Address
Rua Alvarenga Peixoto, 331 apto 42 - Cidade Jardim - Sao Carlos, SP CEP. 13566-582
Country
Brazil
Secondary sponsor category [1] 2521 0
Individual
Name [1] 2521 0
Tania de Fatima Salvini
Address [1] 2521 0
Departamento de Fisioterapia
Rod. Washington Lu?s, km 235, Monjolinho, Sao Carlos, SP CEP. 13565-905
Country [1] 2521 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4710 0
Comite de Etica em Pesquisas em Seres Humanos da Universidade Federal de Sao Carlos
Ethics committee address [1] 4710 0
Pro-Reitoria de Pos-Graduacao da UFSCar Rod. Washington Lu?s, km 235, Monjolinho, Sao Carlos, SP CEP. 13560-970
Ethics committee country [1] 4710 0
Brazil
Date submitted for ethics approval [1] 4710 0
Approval date [1] 4710 0
28/12/2004
Ethics approval number [1] 4710 0
144/04

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
Trial website
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.
Public notes

Contacts
Principal investigator
Name 28181 0
Address 28181 0
Country 28181 0
Phone 28181 0
Fax 28181 0
Email 28181 0
Contact person for public queries
Name 11338 0
Prof. Dr. Tania de Fatima Salvini
Address 11338 0
Departamento de Fisioterapia
Rod. Washington Luís, km 235, Monjolinho, Sao Carlos, SP CEP. 13565-905
Country 11338 0
Brazil
Phone 11338 0
+55 16 3351-8345
Fax 11338 0
+55 16 3361-2081
Email 11338 0
[email protected]
Contact person for scientific queries
Name 2266 0
Prof. Dr. Tania de Fatima Salvini
Address 2266 0
Departamento de Fisioterapia
Rod. Washington Luís, km 235, Monjolinho, Sao Carlos, SP CEP. 13565-905
Country 2266 0
Brazil
Phone 2266 0
+55 16 3351-8345
Fax 2266 0
+55 16 3361-2081
Email 2266 0
[email protected]

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
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