A Prehab Strengthening Program Prior to ACL Surgery on Lower Limb Structure and Function

Study Overview
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Brief Summary
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Atrophy and weakness are ubiquitous after a ACL rupture and associated with a worsened long-term recovery of individual capacities, despite surgery and rehabilitation. Preoperative rehabilitation (prehab) is believed to prepare patients for surgery and post-operative rehabilitation. However, prehab programs are highly variable, and do not always aim to develop/maintain neuromuscular parameters. The purpose of this study is to assess the effects of a lower limb strengthening training program during prehab prior to ACL Surgery on lower limb structure and function.

Detailed Description
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Recruited participants will be randomly allocated to one of the three groups of participants constituted in this study. The two first groups will receive prehabilitation prior to ACL reconstruction (differing in program type). All participants will receive standardized post-surgery rehabilitation (based on international recommandations).

Official Title
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The Effects of a Lower Limb Strengthening Training Program During Prehabilitation Prior to ACL Surgery on Lower Limb Structure and Function : a Randomized Clinical Trial

Conditions
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ACL Injury

Intervention / Treatment
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* Behavioral: Strengthening
* Behavioral: Conventional


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age : 18 to 55 first episode of ACL injury having a planed ACL reconstruction volunteer to participate Exclusion Criteria: age : <18 or >55 previous episode of ACL injury/reconstruction no ACL reconstruction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Strengthening<br>Participants received a 9-weeks strengthening-based prehabilitation program before ACL reconstruction, followed by a standardized post-operative rehabilitation program | Behavioral: Strengthening<br>* 3x/w, 9 wks supervised strengthening program, during prehabilitation to ACL surgery<br>|
| Active Comparator: Conventional<br>Participants received a 9-weeks conventional prehabilitation program (targeting pain knee mobility) before ACL reconstruction, followed by a standardized post-operative rehabilitation program | Behavioral: Conventional<br>* Participants received a 9-weeks conventional prehabilitation program (targeting pain knee mobility) before ACL reconstruction, followed by a standardized post-operative rehabilitation program<br>|
| No Intervention: Control<br>No prehabilitation program Participants received only a standardized post-operative rehabilitation program | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in muscle strength of the knee muscles | Maximal muscle strength of knee flexors/extensors will be assessed using isokinetic dynamometer, and extension and flexion torques during a maximum voluntary contraction (MVC). Unit : Newton meter (Nm) | week 0 (baseline); week 9 (post-intervention, short term) ; 6 months after the surgery (post-intervention, mid-term) and 12 months after the surgery (post-intervention, long-term) | 
| Change in muscle volume of the knee muscles | Muscle volume of the knee muscles (hamstring and quadriceps) will be assessed using 3D ultrasound imaging, at rest in a prone (hamstring) or supined (quadriceps) position. Unit : millimeters (mL) | week 0 (baseline); week 9 (post-intervention, short term) ; 6 months after the surgery (post-intervention, mid-term) and 12 months after the surgery (post-intervention, long-term) | 
| Change in the stiffness of knee muscles | An index of muscle stiffness will be assessed via the shear modulus using ultrasound shear wave elastography, at rest in a prone (hamstring) or supined (quadriceps) position. Unit : kiloPascals (kPa) | week 0 (baseline); week 9 (post-intervention, short term) ; 6 months after the surgery (post-intervention, mid-term) and 12 months after the surgery (post-intervention, long-term) | 
| Change in lower limb function | Single leg hop test. Participants will be instructed to jump as far as possible on a single leg, without losing balance and landing firmly. The distance is measured from the start line to the heel of the landing leg. Unit : centimeters (cm) | week 0 (baseline); week 9 (post-intervention, short term) ; 6 months after the surgery (post-intervention, mid-term) and 12 months after the surgery (post-intervention, long-term) | 
| Change in patient's opinion about the knee and associated problems | Patient's self-related opinion about symptoms and activity will be assessed using the International Knee Documentation Committee Subjective Knee Form (IKDC).The IKDC is consisted of 10 questions. Unit : score, scaled between 0 (=bad) and 100 (= good function) | week 0 (baseline); week 9 (post-intervention, short term) ; 6 months after the surgery (post-intervention, mid-term) and 12 months after the surgery (post-intervention, long-term) | 
| Change in patient's opinion to return to sport | Patient's self-related opinion out the impact of returning to sport will be assessed using the Anterior Cruciate Ligament - Return to Sport after Injury (ACL-RSI) questionnaire. The ACL-RSI consists of 12 questions. Unit : score, scaled between 0 (=bad) and 100 (= more psychologically ready to return to sport) | week 0 (baseline); week 9 (post-intervention, short term) ; 6 months after the surgery (post-intervention, mid-term) and 12 months after the surgery (post-intervention, long-term) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health consumption | Drugs intakes, dates of physiotherapy/medical consultations, date of return to work will be assessed through a diary Unit : self-reported date, in a paper diary | week 0 (baseline); week 9 (post-intervention, short term) ; 6 months after the surgery (post-intervention, mid-term) and 12 months after the surgery (post-intervention, long-term) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rehabilitation, strengthening, physiotherapy, atrophy