Muscle Strengthening and Return-to-exercise Criteria After Anterior Cruciate Ligament Reconstruction (ACLR) (ACLR)

April 12, 2023 updated by: Ariadna del Villar Morales, National Institute of Rehabilitation, Mexico

Comparison of Two Muscle Strengthening Programs on the Return-to-exercise Criteria in Patients With Anterior Cruciate Ligament Reconstruction

Anterior cruciate ligament injury is very common in recreational and elite athletes. It is considered the second most frequent pathology seeing in Sports Medicine Services. After the injury and ACLR, there is a marked decrease in the strength of the knee extensors/flexors muscles. Strength exercise programs are aimed at recovering strength and functionality, however, a low percentage of patients manage to achieve the optimal return-to-exercise criteria. Therefore, it is relevant to design and evaluate exercise programs that allow early recovery of muscle strength and knee functionality. The main purpose of this study is to investigate a neuromuscular exercise program compared with a standard institutional program in the recovery of the strength and functionality of the knee extensor/flexor muscles after ACLR.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Study design: this is a 22-week, randomized trial. 62 participants will be recruited from the medical services of the National Institute of Rehabilitation (NIR).

Participants: adults between 20-40 years old, with a body mass index <30.0 kg/mˆ2, history of sports practice immediately prior to the injury, post-operated unilaterally for ACL with the hamstring autograft technique (semitendinosus-gracilis tendons), with full ranges of motion and no edema will be recruited. Participants with multi-ligament knee injuries, with more than 12 months from the injury to surgery or more than 8 months after surgery, with uncompensated metabolic diseases or acute illnesses/infections under treatment will not be recruited.

Intervention: participants will be randomized to 1) neuromuscular or 2) institutional exercise program with computer-generated random numbers. Both programs consist of isotonic open and closed kinetic chain exercises for the hip and knee. The neuromuscular program also includes exercises to improve vastus medialis and lateralis strength, hamstrings, hip flexors and extensors, proprioception, and core stability. On the other hand, the institutional program includes concentric and eccentric knee exercises. Both programs will be performed 3 days/week, 3 sets, 18-22 repetitions for each exercise; the intensity will initiate at 65-75% (1RM), and it will be increased to 75-85%; the workload will be increased 5-10% from the fifth week according to perceived exertion. The exercises will be done with both legs; however, the injured leg will be exercised complementary. The last 6 weeks of the programs correspond to functional exercises according the sport. Every training session will consist of 15 minutes of warm-up, 40-60 minutes of resistance training, and 15 minutes of cool-down; all training sessions will take place in the NIR Sports Medicine therapeutic gym.

The knee flexors/extensors muscle strength will be determined by isokinetic dynamometry (at 60°/s). The knee function will be evaluated by hop tests and agility T-test. The patient's perception of daily functional activities after ACL reconstruction will be assessed by the Lysholm knee score.

For each participant, the study length will be 22 weeks with 66 exercise sessions. The beginning of the study corresponds to session 1 of exercise. Initial evaluation will be performed 5 days prior to the start of the intervention, while final evaluations will be conducted at the end of 22 weeks of follow-up (2 days after the last day of the intervention). Data will be recorded by study investigators.

Study Type

Interventional

Enrollment (Anticipated)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Rebeca S Romero, MSc
  • Phone Number: 15224 525559991000
  • Email: rsalas@inr.gob.mx

Study Locations

  • Mexico
      • Ciudad de Mexico, Mexico, 14389
        • Recruiting
        • National Institute of Rehabilitation
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • History of sports practice immediately prior to the injury
  • Post-operated unilaterally for ACL with the hamstring autograft technique (semitendinosus-gracilis tendons),
  • Full ranges of motion and no edema
  • Body mass index < 30.0 kg/mˆ2

Exclusion Criteria:

  • Multi-ligament knee injuries,
  • More than 12 months from the injury to surgery
  • More than 8 months after surgery
  • Uncompensated metabolic diseases
  • Acute illnesses/infections under treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neuromuscular exercise program
Participants on a neuromuscular exercise program
Other: Neuromuscular exercise program
Participants will complete a neuromuscular program during 22 weeks. The program consist of isotonic open and closed kinetic chain exercises for the hip and knee, and training to improve hip and knee muscles strength, proprioception, and core stability.
Active Comparator: Institutional exercise program
Participants on an institutional exercise program
Other: Institutional exercise program
Participants will complete an institutional exercise program during 22 weeks. The program consist of isotonic open and closed kinetic chain exercises for the hip and knee, and concentric and eccentric knee exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee flexors muscle strength asymmetry
Time Frame: 22 weeks

The asymmetry will be calculated as the percentage of the peak knee flexor torque in the involved limb over the peak knee flexor torque in the uninvolved limb, multiplied by 100.

Asymmetry % = (peak flexor torque involved limb/ peak flexor torque uninvolved limb) *100
22 weeks
Knee extensors muscle strength asymmetry
Time Frame: 22 weeks

The asymmetry will be calculated as the percentage of the peak knee extensor torque in the involved limb over the peak knee extensor torque in the uninvolved limb, multiplied by 100.

Asymmetry % = (peak extensor torque involved limb/peak extensor torque uninvolved limb)*100
22 weeks
Hop distance asymmetry
Time Frame: 22 weeks

The asymmetry will be calculated as the percentage of the hop distance (one leg hop, triple hop, or cross-over hop) in the involved limb over the hop distance in the uninvolved limb, multiplied by 100.

Asymmetry % = (hop distance involved limb/hop distance uninvolved limb)*100
22 weeks
Agility T-test time
Time Frame: 22 weeks
The time will be determined with data obtained from T-test; the fastest time will be recorded.
22 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Leg muscle quality index (MQIleg)
Time Frame: Baseline and 22 weeks

The muscle quality index from legs will be calculated with data obtained by isokinetic dynamometry, and lean mass obtained by bioimpedance analysis .

MQIleg = peak torque (Nm) / leg lean mass (kg)
Baseline and 22 weeks
Lysholm knee score
Time Frame: Baseline and 22 weeks
The score consists of eighth questions rated to produce an overall score on a point scale of 0 to 100. An assignment is given as excellent for 95 to 100 points, good for 84 to 94 points, fair for 66 to 83 points, and poor for less than 65 points.
Baseline and 22 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Rehabilitation, Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2021

Primary Completion (Anticipated)

December 20, 2023

Study Completion (Anticipated)

March 20, 2024

Study Registration Dates

First Submitted

March 30, 2023

First Submitted That Met QC Criteria

April 12, 2023

First Posted (Actual)

April 14, 2023

Study Record Updates

Last Update Posted (Actual)

April 14, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27/21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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 Injuries

Clinical Trials on Neuromuscular exercise program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe