- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02961530
Effect of Rehabilitation Programs Based on Eccentric Exercise of Knee Extensor Muscles in Isotonic and Isokinetic Conditions After Partial Menisectomy
A randomized clinical trial involving 32 individuals submitted to partial menisectomy will be conducted.
Participants will be randomized into: Group I, submitted to a muscular rehabilitation program based on eccentric isokinetic exercise; and Group II, submitted to a muscular rehabilitation program based on eccentric isotonic exercise. Concomitantly with the muscular rehabilitation protocols, individuals will undergo the same physiotherapeutic protocol with analgesia, edema reduction, range of motion, proprioception and functionality goals. Muscle rehabilitation programs based on eccentric isotonic and isokinetic exercise will begin 15 days after partial menisectomy. The programs will last six weeks, with training frequency of two sessions per week, separated by a minimum interval of 72 hours.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
RS
-
Porto Alegre, RS, Brazil, 90050170
- Universidade Federal de Ciências da Saúde de Porto Alegre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Young adults aged between 18 and 40 years;
- Recreational athletes;
- Unilateral partial meniscal tear;
- Partial meniscectomy by video-arthroscopy within 90 days after injury;
- Male subjects;
- Classification of body mass index up to pre-obese (25.0 - 29.9 kg / m2);
- Not undergoing any strength training program for the lower limbs in the six months prior to the study;
- Acceptance of individuals in participating in the procedures proposed by the research.
Exclusion Criteria:
Repeated meniscal tear; Associated ligament injuries; Previous history (<6 months) of musculoskeletal lesions in the thigh; Patellar tendinopathy; Patellofemoral pain syndrome; Respiratory or cardiovascular conditions that limit the performance of exercises; Users of dietary supplements or anabolic steroids
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1.
The participants randomly allocated to this arm will undergo a muscular rehabilitation program based on the isokinetic eccentric exercise for the extensor muscles of the operated knee. The contralateral non-operated lower limb will be used as control, so it will not undergo any muscular rehabilitation program. |
The individuals of both groups will be submitted to the same physiotherapeutic protocol with objectives of analgesia, reduction of edema, recovery of range of motion, proprioception and functionality. 15 days after partial menisectomy, subjects randomly allocated to this arm will be submitted to a muscle rehabilitation program based on isokinetic eccentric exercise lasting six weeks, with training frequency of two sessions per week, separated by a minimum interval of 72 hours. |
|
Active Comparator: Group 2.
The participants randomly allocated to this arm will undergo a muscular rehabilitation program based on the isotonic eccentric exercise for the extensor muscles of the operated knee. The contralateral non-operated lower limb will be used as control, so it will not undergo any muscular rehabilitation program. |
The individuals of both groups will be submitted to the same physiotherapeutic protocol with objectives of analgesia, reduction of edema, recovery of range of motion, proprioception and functionality. 15 days after partial menisectomy, subjects randomly allocated to this arm will be submitted to a muscle rehabilitation program based on isotonic eccentric exercise lasting six weeks, with training frequency of two sessions per week, separated by a minimum interval of 72 hours. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The femoral quadriceps muscle mass through nuclear magnetic resonance imaging
Time Frame: Change from baseline and six weeks after intervention protocol
|
Change from baseline and six weeks after intervention protocol
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Performance of knee extensors through computerized dynamometry
Time Frame: Change from baseline and six weeks after intervention protocol
|
Change from baseline and six weeks after intervention protocol
|
|
Functionality of the individuals through Lysholm score
Time Frame: Change from baseline and six weeks after intervention protocol
|
Change from baseline and six weeks after intervention protocol
|
|
Functionality of the individuals through single and triple hop test
Time Frame: Change from baseline and six weeks after intervention protocol
|
Change from baseline and six weeks after intervention protocol
|
Collaborators and Investigators
Investigators
- Principal Investigator: Marlon F Vidmar, MSc, Federal University of Health Science of Porto Alegre
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FUHSPortoAlegre_IV
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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