Effect of Rehabilitation Programs Based on Eccentric Exercise of Knee Extensor Muscles in Isotonic and Isokinetic Conditions After Anterior Cruciate Ligament Reconstruction

NCT ID: NCT02961543

Last Updated: 2018-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anterior Cruciate Ligament Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Isokinetic eccentric exercises

Intervention Type OTHER

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.

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.

Group Type ACTIVE_COMPARATOR

Isotonic eccentric exercises

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Isokinetic eccentric exercises

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.

Intervention Type OTHER

Isotonic eccentric exercises

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Federal University of Health Science of Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Marlon Francys Vidmar

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marlon F Vidmar, MSc

Role: PRINCIPAL_INVESTIGATOR

Federal University of Health Science of Porto Alegre

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universidade Federal de Ciências da Saúde de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FUHSPortoAlegre_III

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.