Anterior Cruciate Ligament (ACL)K-POPNCT07411625
Preoperative Rehabilitation for Patient With an ACL Injury
A study testing Resistance training and Traditional exercises in people with Anterior Cruciate Ligament (ACL), run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Cruciate Ligament (ACL)
- What is being tested?
- Resistance training and Traditional exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- 17 Mar 2026to 15 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital - Laboratoire "Motricité, Interactions, Performance" (UR 4334)
Nantes, 44000
Antoine FROUIN, +33 02 53 48 28 35, Antoine.Frouin1@univ-nantes.fr
About this study
Official title: Comparison of Two Programs Delivered During Rehabilitation Before an Anteriror Cruciate Ligament Reconstruction : a Randomised Controlled Trial K-POP
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)
- Being tested
- Resistance training, Traditional exercises
- Keywords
- Rehabilitation, Preoperative resistance training, Strength, Voluntary activation, Muscle Volume
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance trainingOther
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 exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Traditional exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: In the week following the 9 weeks of preoperative rehabilitation
Secondary outcomes (6)
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°)
Measured: 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
Voluntary activation will be measured by interpolated twitch technique on knee extensor muscles.
Measured: 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
Muscle volume will be assessed by 3D ultrasound on quadriceps and hamstring muscles
Measured: 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
Patient reported outcomes will be measured by the KOOS questionnaire
Measured: 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.
Patient reported outcomes will be measured by the SANE scale.
Measured: First visit, (T0), visit at 9 weeks of preoperative rehabilitation (T1), visit 4 months after surgery (T2), visit 9 months after surgery (T3)
HAD scale
Patient reported outcomes will be measured by the HAD scale
Measured: First visit, (T0), visit at 9 weeks of preoperative rehabilitation (T1), visit 4 months after surgery (T2), visit 9 months after surgery (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start17 Mar 2026
- Primary completion15 Aug 2027 (estimated)
- Study completion15 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament (ACL)Studies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411625
- Sponsor's protocol ID
- RC25_0050
- Acronym
- K-POP
- Status last verified
- Mar 2026
- First submitted
- 30 Jan 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Programs Delivered During Rehabilitation Before an Anteriror Cruciate Ligament Reconstruction : a Randomised Controlled Trial K-POP
- ClinicalTrials.gov ID
- NCT07411625
- Acronym / sponsor ID
- K-POP / RC25_0050
- Conditions
- Anterior Cruciate Ligament (ACL)
- Keywords
- Rehabilitation, Preoperative resistance training, Strength, Voluntary activation, Muscle Volume
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 17 Mar 2026 (actual)
- Primary completion
- 15 Aug 2027 (estimated)
- Study completion
- 15 Aug 2027 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance training group | Experimental | Other: Resistance trainingParticipants of 'resistance training' group will perform a training program built on the principles of strength training to increase knee muscles strength and volume. |
| Usual group | Active comparator | Other: Traditional exercisesParticipants of 'usual group' will perform traditional exercises including: balance/proprioceptive exercises, weight-balances exercises, and body-weight resistance training exercises. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance trainingParticipants 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). | Other | Resistance training group |
| Traditional exercisesParticipants 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. | Other | Usual group |
Primary outcome
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.
6 secondary outcomes
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)
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)
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)
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training and Traditional exercises in people with Anterior Cruciate Ligament (ACL), run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antoine FROUIN (+33 02 53 48 28 35, Antoine.Frouin1@univ-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal torque for knee extension in isometric condition (time frame: In the week following the 9 weeks of preoperative rehabilitation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.