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

Primary Purpose

Anterior Cruciate Ligament Injury

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Isokinetic eccentric exercises
Isotonic eccentric exercises
Sponsored by
Federal University of Health Science of Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Injury

Eligibility Criteria

18 Years - 40 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Universidade Federal de Ciências da Saúde de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1.

Group 2.

Arm Description

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 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.

Outcomes

Primary Outcome Measures

The femoral quadriceps muscle mass through nuclear magnetic resonance imaging

Secondary Outcome Measures

Performance of knee extensors through computerized dynamometry
Functionality of the individuals through Lysholm score
Functionality of the individuals through single and triple hop test

Full Information

First Posted
November 9, 2016
Last Updated
February 7, 2018
Sponsor
Federal University of Health Science of Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT02961543
Brief Title
Effect of Rehabilitation Programs Based on Eccentric Exercise of Knee Extensor Muscles in Isotonic and Isokinetic Conditions After Anterior Cruciate Ligament Reconstruction
Official Title
Effect of Rehabilitation Programs Based on Eccentric Exercise of Knee Extensor Muscles in Isotonic and Isokinetic Conditions After Anterior Cruciate Ligament Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Health Science of Porto Alegre

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1.
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2.
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Isokinetic eccentric exercises
Intervention Description
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
Intervention Name(s)
Isotonic eccentric exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
The femoral quadriceps muscle mass through nuclear magnetic resonance imaging
Time Frame
Change from baseline and six weeks after intervention protocol
Secondary Outcome Measure Information:
Title
Performance of knee extensors through computerized dynamometry
Time Frame
Change from baseline and six weeks after intervention protocol
Title
Functionality of the individuals through Lysholm score
Time Frame
Change from baseline and six weeks after intervention protocol
Title
Functionality of the individuals through single and triple hop test
Time Frame
Change from baseline and six weeks after intervention protocol

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marlon F Vidmar, MSc
Organizational Affiliation
Federal University of Health Science of Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal de Ciências da Saúde de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90050170
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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