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

Primary Purpose

Anterior Cruciate Ligament Injuries

Status
Recruiting
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Neuromuscular exercise program
Institutional exercise program
Sponsored by
National Institute of Rehabilitation, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Injuries

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Institute of RehabilitationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Neuromuscular exercise program

Institutional exercise program

Arm Description

Participants on a neuromuscular exercise program

Participants on an institutional exercise program

Outcomes

Primary Outcome Measures

Knee flexors muscle strength asymmetry
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
Knee extensors muscle strength asymmetry
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
Hop distance asymmetry
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
Agility T-test time
The time will be determined with data obtained from T-test; the fastest time will be recorded.

Secondary Outcome Measures

Leg muscle quality index (MQIleg)
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)
Lysholm knee score
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.

Full Information

First Posted
March 30, 2023
Last Updated
April 12, 2023
Sponsor
National Institute of Rehabilitation, Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT05814445
Brief Title
Muscle Strengthening and Return-to-exercise Criteria After Anterior Cruciate Ligament Reconstruction (ACLR)
Acronym
ACLR
Official Title
Comparison of Two Muscle Strengthening Programs on the Return-to-exercise Criteria in Patients With Anterior Cruciate Ligament Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 20, 2021 (Actual)
Primary Completion Date
December 20, 2023 (Anticipated)
Study Completion Date
March 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute of Rehabilitation, Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neuromuscular exercise program
Arm Type
Experimental
Arm Description
Participants on a neuromuscular exercise program
Arm Title
Institutional exercise program
Arm Type
Active Comparator
Arm Description
Participants on an institutional exercise program
Intervention Type
Other
Intervention Name(s)
Neuromuscular exercise program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Institutional exercise program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Knee flexors muscle strength asymmetry
Description
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
Time Frame
22 weeks
Title
Knee extensors muscle strength asymmetry
Description
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
Time Frame
22 weeks
Title
Hop distance asymmetry
Description
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
Time Frame
22 weeks
Title
Agility T-test time
Description
The time will be determined with data obtained from T-test; the fastest time will be recorded.
Time Frame
22 weeks
Secondary Outcome Measure Information:
Title
Leg muscle quality index (MQIleg)
Description
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)
Time Frame
Baseline and 22 weeks
Title
Lysholm knee score
Description
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.
Time Frame
Baseline and 22 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea P Perez, MSc
Phone
525559991000
Ext
15302
Email
apegueros@inr.gob.mx
First Name & Middle Initial & Last Name or Official Title & Degree
Rebeca S Romero, MSc
Phone
525559991000
Ext
15224
Email
rsalas@inr.gob.mx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ariadna d Morales, MD
Organizational Affiliation
National Institute of Rehabilitation
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of Rehabilitation
City
Ciudad de Mexico
ZIP/Postal Code
14389
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea P Perez, MSc
Phone
525559991000
Ext
15302
Email
apegueros@inr.gob.mx
First Name & Middle Initial & Last Name & Degree
Rebeca S Romero, MSc
Phone
525559991000
Ext
15224
Email
rsalas@inr.gob.mx

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Citation
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Links:
URL
https://cdn-kneeacl.pressidium.com/wp-content/uploads/2015/07/NET5359_Netball_Aus_RecreationalProgram_Manual_LR.pdf
Description
The knee program - recreational manual
URL
https://australia.rugby/participate/coach/coaching-resources/world-rugby-activate
Description
Activate adult. World rugby injury prevention exercise programme.

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

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