Preoperative Rehabilitation for Patient With an ACL Injury
ConditionAnterior Cruciate Ligament (ACL)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNantes University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Resistance training
Other interventionParticipants 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 interventionParticipants 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.
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: Resistance training groupExperimental treatment 1 intervention
Group B: Usual groupActive comparator 1 intervention
Trial outcomes
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.
Time frame
In the week following the 9 weeks of preoperative rehabilitationSecondary outcomes
1
Knee extension and flexion torque
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°)
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)2
Voluntary activation
Voluntary activation will be measured by interpolated twitch technique on knee extensor muscles.
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)3
Change in muscle volume
Muscle volume will be assessed by 3D ultrasound on quadriceps and hamstring muscles
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)4
KOOS questionnaire
Patient reported outcomes will be measured by the 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)Sponsors and contacts
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Source ClinicalTrials.gov