Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07411625

Preoperative Rehabilitation for Patient With an ACL Injury

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Nantes, 44000, France

Location status: Recruiting

Location contact

Antoine FROUIN

CONTACT

[email protected]

+33 02 53 48 28 35

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

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).

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.

Primary outcomes

  1. Maximal torque for knee extension in isometric condition

    Time frame: In the week following the 9 weeks of preoperative rehabilitation

    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.

Secondary outcomes

  1. Knee extension and flexion torque

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

    The maximal torque, between-leg symmetry index (injured side/contralateral side), for Knee Extension and Knee Flexion will be calculated at the different endpoints, for each condition (80° and 30°)

  2. Voluntary activation

    Time frame: 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 will be measured by interpolated twitch technique on knee extensor muscles.

  3. Change in muscle volume

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

    Muscle volume will be assessed by 3D ultrasound on quadriceps and hamstring muscles

  4. KOOS questionnaire

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

    Patient reported outcomes will be measured by the KOOS questionnaire

  5. SANE scale.

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

    Patient reported outcomes will be measured by the SANE scale.

  6. HAD scale

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

    Patient reported outcomes will be measured by the HAD scale

Study contacts

Contact information is provided by the study sponsor or research team.

Antoine FROUIN

CONTACT

[email protected]

+33 02 53 48 28 35

Guillaume LE SANT

CONTACT

[email protected]

+33 02 53 48 28 35

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Comparison of Two Programs Delivered During Rehabilitation Before an Anteriror Cruciate Ligament Reconstruction : a Randomised Controlled Trial K-POP

Acronym: K-POP

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 17, 2026
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.