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Preoperative Rehabilitation for Patient With an ACL Injury

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07411625
Acronym
K-POP
Enrollment
84
Registered
2026-02-17
Start date
2026-03-17
Completion date
2027-08-15
Last updated
2026-03-20

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

Conditions

Anterior Cruciate Ligament (ACL)

Keywords

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

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.

Interventions

OTHERResistance training

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).

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.

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

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

Masking description

The investigator will be blinded of the group allocation and will also blinded of the measurement time when processing datas.

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
Maximal torque for knee extension in isometric conditionIn the week following the 9 weeks of preoperative rehabilitationThe 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

MeasureTime frameDescription
Knee extension and flexion torqueFirst 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°)
Voluntary activationFirst 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.
Change in muscle volumeFirst 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
KOOS questionnaireFirst 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
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)Patient reported outcomes will be measured by the SANE scale.
HAD scaleFirst 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

Countries

France

Contacts

CONTACTAntoine FROUIN
Antoine.Frouin1@univ-nantes.fr+33 02 53 48 28 35
CONTACTGuillaume LE SANT
Guillaume.LE-SANT@ifm3r.eu+33 02 53 48 28 35

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026