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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05374382
Acronym
ACL-Strong
Enrollment
75
Registered
2022-05-16
Start date
2022-09-30
Completion date
2024-09-30
Last updated
2022-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ACL Injury

Keywords

rehabilitation, strengthening, physiotherapy, atrophy

Brief summary

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

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).

Interventions

BEHAVIORALConventional

Participants received a 9-weeks conventional prehabilitation program (targeting pain knee mobility) before ACL reconstruction, followed by a standardized post-operative rehabilitation program

BEHAVIORALStrengthening

3x/w, 9 wks supervised strengthening program, during prehabilitation to ACL surgery

Sponsors

Université de Nantes
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in muscle volume of the knee musclesweek 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)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)
Change in lower limb functionweek 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)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)
Changes in muscle strength of the knee musclesweek 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)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)
Change in patient's opinion to return to sportweek 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)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)
Change in the stiffness of knee musclesweek 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)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)
Change in patient's opinion about the knee and associated problemsweek 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)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)

Secondary

MeasureTime frameDescription
Health consumptionweek 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)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

Countries

France

Contacts

Primary ContactGuillaume Le Sant, PhD, PT
guillaume.le-sant@univ-nantes.fr+251837234
Backup ContactAntoine Nordez, PhD
antoine.nordez@univ-nantes.fr+251837208

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026