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

NCT05374382 | Unknown

• 1 other identifier: ACL-Strong
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

ACL Injury

Keywords

rehabilitation; strengthening; physiotherapy; atrophy

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Health consumption

  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)

Study Arms (3)

Strengthening

EXPERIMENTAL

Participants received a 9-weeks strengthening-based prehabilitation program before ACL reconstruction, followed by a standardized post-operative rehabilitation program

Behavioral: Strengthening

Conventional

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

No prehabilitation program Participants received only a standardized post-operative rehabilitation program

Interventions

Strengthening BEHAVIORAL

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

Strengthening

Conventional BEHAVIORAL

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

Conventional

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• age : 18 to 55
• first episode of ACL injury
• having a planed ACL reconstruction
• volunteer to participate

You may not qualify if:

• age : \<18 or \>55
• previous episode of ACL injury/reconstruction
• no ACL reconstruction

Sponsors & Collaborators

• Université de Nantes: lead

Study Sites (1)

Université de Nantes - MIP UR 4334 (Motricity, Movement, Interactions)

Nantes, France

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Atrophy

Interventions

Resistance Training; Congresses as Topic

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Organizations; Health Care Economics and Organizations

Study Officials

• Guillaume Le Sant, PhD, PT

  Université de Nantes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillaume Le Sant, PhD, PT

CONTACT

+251837234; guillaume.le-sant@univ-nantes.fr

Antoine Nordez, PhD

CONTACT

+251837208; antoine.nordez@univ-nantes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Guillaume Le Sant, PhD,PT. Physiotherapist and Researcher

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 16, 2022
• Study Start: September 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2024
• Last Updated: May 16, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)