ACL InjuryACL-StrongNCT05374382
A Prehab Strengthening Program Prior to ACL Surgery on Lower Limb Structure and Function
A study testing Strengthening and Conventional in people with ACL Injury, run by Université de Nantes at 1 site in France.
Trial summary
Atrophy and weakness are ubiquitous after a ACL rupture and associated with a worsened long-term recovery of individual capacities, despite surgery and rehabilitation. Preoperative rehabilitation (prehab) is believed to prepare patients for surgery and post-operative rehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- ACL Injury
- What is being tested?
- Strengthening and Conventional
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2022to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age : 18 to 55
- first episode of ACL injury
- having a planed ACL reconstruction
- volunteer to participate
Who cannot join
- age : <18 or >55
- previous episode of ACL injury/reconstruction
- no ACL reconstruction
Trial locations and contacts
1 site in 1 country.
France1 site
Université de Nantes - MIP UR 4334 (Motricity, Movement, Interactions)
Nantes
Guillaume Le Sant, PT, PhD, +251837234, guillaume.le-sant@univ-nantes.fr
Lilian Lacourpaille, PhD
About this study
Official title: The Effects of a Lower Limb Strengthening Training Program During Prehabilitation Prior to ACL Surgery on Lower Limb Structure and Function : a Randomized Clinical Trial
Atrophy and weakness are ubiquitous after a ACL rupture and associated with a worsened long-term recovery of individual capacities, despite surgery and rehabilitation. Preoperative rehabilitation (prehab) is believed to prepare patients for surgery and post-operative rehabilitation. However, prehab programs are highly variable, and do not always aim to develop/maintain neuromuscular parameters.
The purpose of this study is to assess the effects of a lower limb strengthening training program during prehab prior to ACL Surgery on lower limb structure and function.
Read the detailed description
Recruited participants will be randomly allocated to one of the three groups of participants constituted in this study.
The two first groups will receive prehabilitation prior to ACL reconstruction (differing in program type). All participants will receive standardized post-surgery rehabilitation (based on international recommandations).
- Conditions
- ACL Injury
- Being tested
- Strengthening, Conventional
- Keywords
- rehabilitation, strengthening, physiotherapy, atrophy
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StrengtheningBehavioural
3x/w, 9 wks supervised strengthening program, during prehabilitation to ACL surgery
ConventionalBehavioural
Participants received a 9-weeks conventional prehabilitation program (targeting pain knee mobility) before ACL reconstruction, followed by a standardized post-operative rehabilitation program
| Study group | Role | What they receive |
|---|---|---|
| Strengthening | Experimental | Participants received a 9-weeks strengthening-based prehabilitation program before ACL reconstruction, followed by a standardized post-operative rehabilitation program Receives: Behavioral: Strengthening |
| Conventional | Active comparator | Participants received a 9-weeks conventional prehabilitation program (targeting pain knee mobility) before ACL reconstruction, followed by a standardized post-operative rehabilitation program Receives: Behavioral: Conventional |
| Control | No intervention | No prehabilitation program Participants received only a standardized post-operative rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in muscle strength of the knee muscles
Maximal muscle strength of knee flexors/extensors will be assessed using isokinetic dynamometer, and extension and flexion torques during a maximum voluntary contraction (MVC).
Unit : Newton meter (Nm)
Measured: week 0 (baseline); week 9 (post-intervention, short term) ; 6 months after the surgery (post-intervention, mid-term) and 12 months after the surgery (post-intervention, long-term)
Change in muscle volume of the knee muscles
Muscle volume of the knee muscles (hamstring and quadriceps) will be assessed using 3D ultrasound imaging, at rest in a prone (hamstring) or supined (quadriceps) position.
Unit : millimeters (mL)
Measured: week 0 (baseline); week 9 (post-intervention, short term) ; 6 months after the surgery (post-intervention, mid-term) and 12 months after the surgery (post-intervention, long-term)
Change in the stiffness of knee muscles
An index of muscle stiffness will be assessed via the shear modulus using ultrasound shear wave elastography, at rest in a prone (hamstring) or supined (quadriceps) position.
Unit : kiloPascals (kPa)
Measured: week 0 (baseline); week 9 (post-intervention, short term) ; 6 months after the surgery (post-intervention, mid-term) and 12 months after the surgery (post-intervention, long-term)
Change in lower limb function
Single leg hop test. Participants will be instructed to jump as far as possible on a single leg, without losing balance and landing firmly. The distance is measured from the start line to the heel of the landing leg.
Unit : centimeters (cm)
Measured: week 0 (baseline); week 9 (post-intervention, short term) ; 6 months after the surgery (post-intervention, mid-term) and 12 months after the surgery (post-intervention, long-term)
Change in patient's opinion about the knee and associated problems
Patient's self-related opinion about symptoms and activity will be assessed using the International Knee Documentation Committee Subjective Knee Form (IKDC).The IKDC is consisted of 10 questions.
Unit : score, scaled between 0 (=bad) and 100 (= good function)
Measured: week 0 (baseline); week 9 (post-intervention, short term) ; 6 months after the surgery (post-intervention, mid-term) and 12 months after the surgery (post-intervention, long-term)
Change in patient's opinion to return to sport
Patient's self-related opinion out the impact of returning to sport will be assessed using the Anterior Cruciate Ligament - Return to Sport after Injury (ACL-RSI) questionnaire.
The ACL-RSI consists of 12 questions. Unit : score, scaled between 0 (=bad) and 100 (= more psychologically ready to return to sport)
Measured: week 0 (baseline); week 9 (post-intervention, short term) ; 6 months after the surgery (post-intervention, mid-term) and 12 months after the surgery (post-intervention, long-term)
Secondary outcomes (1)
Health consumption
Drugs intakes, dates of physiotherapy/medical consultations, date of return to work will be assessed through a diary
Unit : self-reported date, in a paper diary
Measured: week 0 (baseline); week 9 (post-intervention, short term) ; 6 months after the surgery (post-intervention, mid-term) and 12 months after the surgery (post-intervention, long-term)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study startSep 2022 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL InjuryStudies of the same condition, open and under way.
- 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
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Nantes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillaume Le Sant, Université de Nantes
- Investigators
- Guillaume Le Sant, PhD, PT, Principal investigator, Université de Nantes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374382
- Sponsor's protocol ID
- ACL-Strong
- Acronym
- ACL-Strong
- Status last verified
- May 2022
- First submitted
- 2 May 2022
- Last updated
- 16 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Lower Limb Strengthening Training Program During Prehabilitation Prior to ACL Surgery on Lower Limb Structure and Function : a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05374382
- Acronym / sponsor ID
- ACL-Strong / ACL-Strong
- Conditions
- ACL Injury
- Keywords
- rehabilitation, strengthening, physiotherapy, atrophy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Université de NantesUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 16 May 2022 (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.
Atrophy and weakness are ubiquitous after a ACL rupture and associated with a worsened long-term recovery of individual capacities, despite surgery and rehabilitation. Preoperative rehabilitation (prehab) is believed to prepare patients for surgery and post-operative rehabilitation. However, prehab programs are highly variable, and do not always aim to develop/maintain neuromuscular parameters.
The purpose of this study is to assess the effects of a lower limb strengthening training program during prehab prior to ACL Surgery on lower limb structure and function.
Detailed description
Recruited participants will be randomly allocated to one of the three groups of participants constituted in this study.
The two first groups will receive prehabilitation prior to ACL reconstruction (differing in program type). All participants will receive standardized post-surgery rehabilitation (based on international recommandations).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Strengthening | Experimental | Behavioral: StrengtheningParticipants received a 9-weeks strengthening-based prehabilitation program before ACL reconstruction, followed by a standardized post-operative rehabilitation program |
| Conventional | Active comparator | Behavioral: ConventionalParticipants received a 9-weeks conventional prehabilitation program (targeting pain knee mobility) before ACL reconstruction, followed by a standardized post-operative rehabilitation program |
| Control | No intervention | –No prehabilitation program Participants received only a standardized post-operative rehabilitation program |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age : 18 to 55
- first episode of ACL injury
- having a planed ACL reconstruction
- volunteer to participate
Key exclusion criteria (3 listed)
- age : <18 or >55
- previous episode of ACL injury/reconstruction
- no ACL reconstruction
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 |
|---|---|---|
| Strengthening3x/w, 9 wks supervised strengthening program, during prehabilitation to ACL surgery | Behavioural | Strengthening |
| ConventionalParticipants received a 9-weeks conventional prehabilitation program (targeting pain knee mobility) before ACL reconstruction, followed by a standardized post-operative rehabilitation program | Behavioural | Conventional |
Primary outcome
Changes in muscle strength of the knee muscles
Time frame: week 0 (baseline); week 9 (post-intervention, short term) ; 6 months after the surgery (post-intervention, mid-term) and 12 months after the surgery (post-intervention, long-term)
Maximal muscle strength of knee flexors/extensors will be assessed using isokinetic dynamometer, and extension and flexion torques during a maximum voluntary contraction (MVC). Unit : Newton meter (Nm)
Change in muscle volume of the knee muscles
Time frame: week 0 (baseline); week 9 (post-intervention, short term) ; 6 months after the surgery (post-intervention, mid-term) and 12 months after the surgery (post-intervention, long-term)
Muscle volume of the knee muscles (hamstring and quadriceps) will be assessed using 3D ultrasound imaging, at rest in a prone (hamstring) or supined (quadriceps) position. Unit : millimeters (mL)
Change in the stiffness of knee muscles
Time frame: week 0 (baseline); week 9 (post-intervention, short term) ; 6 months after the surgery (post-intervention, mid-term) and 12 months after the surgery (post-intervention, long-term)
An index of muscle stiffness will be assessed via the shear modulus using ultrasound shear wave elastography, at rest in a prone (hamstring) or supined (quadriceps) position. Unit : kiloPascals (kPa)
Change in lower limb function
Time frame: week 0 (baseline); week 9 (post-intervention, short term) ; 6 months after the surgery (post-intervention, mid-term) and 12 months after the surgery (post-intervention, long-term)
Single leg hop test. Participants will be instructed to jump as far as possible on a single leg, without losing balance and landing firmly. The distance is measured from the start line to the heel of the landing leg. Unit : centimeters (cm)
Change in patient's opinion about the knee and associated problems
Time frame: week 0 (baseline); week 9 (post-intervention, short term) ; 6 months after the surgery (post-intervention, mid-term) and 12 months after the surgery (post-intervention, long-term)
Patient's self-related opinion about symptoms and activity will be assessed using the International Knee Documentation Committee Subjective Knee Form (IKDC).The IKDC is consisted of 10 questions. Unit : score, scaled between 0 (=bad) and 100 (= good function)
Change in patient's opinion to return to sport
Time frame: week 0 (baseline); week 9 (post-intervention, short term) ; 6 months after the surgery (post-intervention, mid-term) and 12 months after the surgery (post-intervention, long-term)
Patient's self-related opinion out the impact of returning to sport will be assessed using the Anterior Cruciate Ligament - Return to Sport after Injury (ACL-RSI) questionnaire. The ACL-RSI consists of 12 questions. Unit : score, scaled between 0 (=bad) and 100 (= more psychologically ready to return to sport)
1 secondary outcome
Health consumption
Time frame: week 0 (baseline); week 9 (post-intervention, short term) ; 6 months after the surgery (post-intervention, mid-term) and 12 months after the surgery (post-intervention, long-term)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2022.
- Individual participant dataSharing planned: No
Related trials for ACL Injury
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Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction
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Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
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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. This study is not recruiting at the moment.
Guillaume Le Sant, PhD, PT principal investigator
Université de Nantes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strengthening and Conventional in people with ACL Injury, run by Université de Nantes 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 16 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guillaume Le Sant, PhD, PT (+251837234, guillaume.le-sant@univ-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in muscle strength of the knee muscles (time frame: week 0 (baseline); week 9 (post-intervention, short term) ; 6 months after the surgery (post-intervention, mid-term) and 12 months after the surgery (post-intervention, long-term)). The study lists 6 primary outcomes in all. 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 16 May 2022.