Preoperative Rehabilitation for Patient With an ACL Injury

NCT07411625 | Recruiting

• 1 other identifier: RC25_0050
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Muscle qualities are critical for the recovery after an anterior cruciate ligament (ACL) injury. Before ACL reconstruction (ALCR), resistance training aims to maintain patient strength and volume in order to optimize recovery. Unanswered questions remain on the modalities of resistance training before ACLR. This protocol details a pragmatic clinical trial that primary aims to increase the maximal strength of knee extensors and flexors and to induce hypertrophy before ACLR. Participants awaiting ACLR will be recruited from outpatient rehabilitation clinics and will be randomly allocated to one group to attend a 9-weeks rehabilitation program before ACLR. Participants of 'resistance training' group will perform a training program built on the principles of strength training to increase knee muscles strength and volume. Three blocks of 3 weeks will induce a progressive increase in training load, with exercises performed close to failure. Participants of 'usual group' will perform traditional exercises including: balance/proprioceptive exercises, weight-balances exercises, and body-weight resistance training exercises. Groups will be compared on muscle strength (primary outcome), clinical outcomes (muscle volume, stiffness, knee mobility, effusion) and self-reported outcomes (quality of life, perception of knee function, pain, anxiety and depression, exertion, health consumption, participations in activities) before and after ACLR. Outcomes will be collected by a blinded assessor before and after the resistance training program (before ACLR); 4 and 9 months after the ACLR.

Conditions

Anterior Cruciate Ligament (ACL)

Keywords

Rehabilitation; Preoperative resistance training; Strength; Voluntary activation; Muscle Volume

Outcome Measures

Primary Outcomes (1)

• Maximal torque for knee extension in isometric condition

  The maximal torque for KE strength, measured in MVC isometric condition, will be used to evaluate the between-group differences, at the end of prehabilitation (W9). We will use an ANCOVA (Analysis of covariance) model between strength and group, adjusted to the force measured at baseline to underline the TIME\*GROUP effect.

  In the week following the 9 weeks of preoperative rehabilitation

Secondary Outcomes (6)

• Knee extension and flexion torque

  First visit, (T0), visit at 9 weeks of preoperative rehabilitation (T1), visit 4 months after surgery (T2), visit 9 months after surgery (T3)

• Voluntary activation

  First visit, (T0), visit at 9 weeks of preoperative rehabilitation (T1), visit 4 months after surgery (T2), visit 9 months after surgery (T3)

• Change in muscle volume

  First visit, (T0), visit at 9 weeks of preoperative rehabilitation (T1), visit 4 months after surgery (T2), visit 9 months after surgery (T3)

• KOOS questionnaire

  First visit, (T0), visit at 9 weeks of preoperative rehabilitation (T1), visit 4 months after surgery (T2), visit 9 months after surgery (T3)

• SANE scale.

  First visit, (T0), visit at 9 weeks of preoperative rehabilitation (T1), visit 4 months after surgery (T2), visit 9 months after surgery (T3)

Study Arms (2)

Resistance training group

EXPERIMENTAL

Participants of 'resistance training' group will perform a training program built on the principles of strength training to increase knee muscles strength and volume.

Other: Resistance training

Usual group

ACTIVE COMPARATOR

Participants of 'usual group' will perform traditional exercises including: balance/proprioceptive exercises, weight-balances exercises, and body-weight resistance training exercises.

Other: Traditional exercises

Interventions

Resistance training OTHER

Participants of 'resistance training' group will perform a training program built on the principles of strength training to increase knee muscles strength and volume. Three blocks of 3 weeks will induce a progressive increase in training load, with exercises performed close to failure. The exercising part for participants of 'RT group' will be composed by a progressive increase in load over the 9 weeks. For that purpose, the intensity of load will be increased each 3 weeks (i.e. on the session 1, 10, and 19), using a low-load of 25RM (W1 to W3), mid-load of 10 RM (W4 to W6), and a high-load of 8 RM (W7 to W9) at the end of the program. During each session, the exercise will be performed at an intensity of RPE 9-10 (i.e. near to failure). Based on the literature this progressivity and intensity in loads will target gains in strength and volume among strengthened muscle groups. (Schoenfeld et al., 2021).

Resistance training group

Traditional exercises OTHER

Participants of 'usual group' will perform traditional exercises including: balance/proprioceptive exercises, weight-balances exercises, and body-weight resistance training exercises. The exercising part for participants of 'usual training group' will comport traditional exercises used in prehabilitation, including: balance/proprioceptive exercises, weight-balances exercises, and body-weight resistance training exercises. Again, the 9 weeks will be sub-divided into 3 blocks of 3 weeks for inducing a progressive increase in training load. During w1 to w3, priority will be given to gait, weight balance and knee ROM exercises. From w4 to w7, proprioceptive and jumping exercises will be introduced. During the last 3 weeks, participants will perform 2 sets of 10 repetitions of body-weight exercises.

Usual group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being over 18 years
• A first episode of an ACL injury
• An ACLR scheduled at least 10 weeks later, with a surgical technique using hamstring, gracilis, or quadriceps/patellar tendon autograft
• A minimum passive range of motion of the knee between 10° of extension deficit, and 80° of flexion
• A medical prescription for prehabilitation
• Possibility to attend prehabilitation program and post-ACLR rehabilitation in one of the 15 clinics

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

University Hospital - Laboratoire "Motricité, Interactions, Performance" (UR 4334)

Nantes, 44000, France

RECRUITING

MeSH Terms

Interventions

Resistance Training

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

Central Study Contacts

Antoine FROUIN

CONTACT

+33 02 53 48 28 35; Antoine.Frouin1@univ-nantes.fr

Guillaume LE SANT

CONTACT

+33 02 53 48 28 35; Guillaume.LE-SANT@ifm3r.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator will be blinded of the group allocation and will also blinded of the measurement time when processing datas.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 17, 2026
• Study Start: March 17, 2026
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): August 15, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

FR (1)