- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02961543
Effect of Rehabilitation Programs Based on Eccentric Exercise of Knee Extensor Muscles in Isotonic and Isokinetic Conditions After Anterior Cruciate Ligament Reconstruction
A randomized clinical trial involving 30 individuals submitted to ACL reconstruction 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 45 days after ACL reconstruction. 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 ACL injury;
- Presence of total or partial rupture of unilateral ACL 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:
- Recidivism in ligament injuries;
- Associated ligament and / or meniscal lesions;
- 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. 45 days after ACL reconstruction, 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. 45 days after ACL reconstruction, 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
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUHSPortoAlegre_III
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.
Clinical Trials on Anterior Cruciate Ligament Injury
-
Alexander Rofner-MorettiRecruitingAnterior Cruciate Ligament Rupture | Anterior Cruciate Ligament Reconstruction | Anterior Cruciate Ligament InjuryAustria
-
eMKa MED Medical CenterWroclaw Medical UniversityRecruitingAnterior Cruciate Ligament Injuries | Anterior Cruciate Ligament Rupture | Anterior Cruciate Ligament Tear | Knee Injuries | Knee Ligament InjuryPoland
-
Haute Ecole ARC SanteCompletedAnterior Cruciate Ligament Injury | Anterior Cruciate Ligament Reconstruction RehabilitationSwitzerland
-
eMKa MED Medical CenterWroclaw Medical UniversityRecruitingAnterior Cruciate Ligament Injuries | Anterior Cruciate Ligament Rupture | Anterior Cruciate Ligament Tear | Knee Injuries | Knee Ligament InjuryPoland
-
University of California, San FranciscoArthritis FoundationCompletedAcute Injury of Anterior Cruciate LigamentUnited States
-
University of WashingtonCompletedAnterior Cruciate Ligament Injury | ACL Injury | ACL - Anterior Cruciate Ligament RuptureUnited States
-
Medical University of GrazCompletedAnterior Cruciate Ligament Rupture | Anterior Cruciate Ligament Injury | Knee Instability | Anterior Cruciate Ligament Graft FailureAustria
-
Dr. Lutfi Kirdar Kartal Training and Research HospitalNot yet recruitingAnterior Cruciate Ligament (ACL) Reconstruction | Anterior Cruciate Ligament (ACL) Injury | Anterior Cruciate Ligament (ACL) RuptureTurkey (Türkiye)
-
Universidad de GranadaRecruitingAnterior Cruciate Ligament Injury | Anterior Cruciate Ligament (ACL) ReconstructionSpain
-
Lynn Snyder-MacklerCompletedAcute Injury of Anterior Cruciate LigamentUnited States
Clinical Trials on Isokinetic eccentric exercises
-
Federal University of Health Science of Porto AlegreCompleted
-
King Saud UniversityCompletedMuscle StrengthSaudi Arabia
-
Federal University of Rio Grande do SulCompletedAchilles Tendon RuptureBrazil
-
National and Kapodistrian University of AthensCompletedMuscle Damage | Eccentric ExerciseGreece
-
Universidade Federal de Sao CarlosCoordenaçao de Aperfeiçoamento de Pessoal de Nível SuperiorCompletedShoulder Impingement SyndromeBrazil
-
University Rovira i VirgiliHospital Universitari Sant Joan de ReusUnknownRehabilitation Post-meniscectomySpain
-
Hacettepe UniversityCompleted
-
National and Kapodistrian University of AthensCompletedMenstrual Cycle | Exercise Performance ImpairmentGreece
-
Carrick Institute for Graduate StudiesWithdrawnTherapy, ExerciseUnited States
-
Riphah International UniversityRecruitingKnee Pain Chronic | Patellofemoral Pain | Patello Femoral SyndromePakistan