Effect of Rehabilitation Programs Based on Eccentric Exercise of Knee Extensor Muscles in Isotonic and Isokinetic Conditions After Anterior Cruciate Ligament Reconstruction
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 9, 2016
CompletedFirst Posted
Study publicly available on registry
November 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedFebruary 9, 2018
February 1, 2018
1.4 years
November 9, 2016
February 7, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
The femoral quadriceps muscle mass through nuclear magnetic resonance imaging
Change from baseline and six weeks after intervention protocol
Secondary Outcomes (3)
Performance of knee extensors through computerized dynamometry
Change from baseline and six weeks after intervention protocol
Functionality of the individuals through Lysholm score
Change from baseline and six weeks after intervention protocol
Functionality of the individuals through single and triple hop test
Change from baseline and six weeks after intervention protocol
Study Arms (2)
Group 1.
EXPERIMENTALThe 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.
Group 2.
ACTIVE COMPARATORThe 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidade Federal de Ciências da Saúde de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050170, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marlon F Vidmar, MSc
Federal University of Health Science of Porto Alegre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 9, 2016
First Posted
November 11, 2016
Study Start
July 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
February 9, 2018
Record last verified: 2018-02