Anterior Cruciate Ligament Reconstruction RehabilitationNCT06905691
Effects of Eccentric Training in the Rehabilitation of Patients Undergoing Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Trial
A study testing Conventional Training and Eccentric Training in people with Anterior Cruciate Ligament Reconstruction Rehabilitation and Anterior Cruciate Ligament Reconstruction, run by Federal University of Health Science of Porto Alegre at 2 sites in Brazil.
Trial summary
This study aims to investigate the effects of eccentric training on the functional rehabilitation of patients undergoing Anterior Cruciate Ligament Reconstruction (ACL-R). Thirty-four participants undergoing ACL-R will be randomly assigned to two groups: the Conventional Training Group (CTG) and the Eccentric Training… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction Rehabilitation, Anterior Cruciate Ligament Reconstruction
- What is being tested?
- Conventional Training and Eccentric Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Mar 2025to Dec 2026
- 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 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals of both genders, aged between 18 and 40 years, scheduled for ACL reconstruction surgery during the data collection period.
Who cannot join
- Delay of more than 7 days after surgery to initiate the rehabilitation program proposed by the study;
- Presence of injuries related to the rupture of the ACL that hinder partial weight-bearing in the first week after surgery, either due to medical recommendation or the patient inability/disposition.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil2 sites, 2 recruiting
- Not yet recruiting
Private Rehabilitation Center
Veranópolis, Rio Grande do Sul, 95330000
Gabariela Bissani Gasparin, +5554991296689, gabriela.gasparin@hotmail.com
Gabriela Bissani Gasparin
- Recruiting
Private Rehabilitation Center
Veranópolis, Rio Grande do Sul, 95330000
Gabariela Bissani Gasparin, 54991296689, gabriela.gasparin@hotmail.com
About this study
This study aims to investigate the effects of eccentric training on the functional rehabilitation of patients undergoing Anterior Cruciate Ligament Reconstruction (ACL-R). Thirty-four participants undergoing ACL-R will be randomly assigned to two groups: the Conventional Training Group (CTG) and the Eccentric Training Group (ETG). Both groups will adhere to the same post-surgical rehabilitation program, commencing in the first week after ACL-R and continuing until the criteria for sports resumption are achieved. The rehabilitation program will be structured into four phases: immediate post-operative, preparatory, general acquisition, and specific acquisition. The key distinction between the groups lies in their exercise regimen: ETG will prioritize the eccentric phase of movement, whereas CTG will engage in conventional exercises, maintaining uniform load across both movement phases. Assessment procedures will be conducted at three intervals for all participants: immediately post-operative, at 12 weeks post-ACL-R surgery (before the initiation of the training protocol), and at 25 weeks post-ACL-R surgery (upon completion of the training protocol). The primary outcome measure will be the maximum isometric strength of knee extensors. Secondary outcomes will encompass functional status, maximum isometric strength of knee flexors, peak dynamic strength during leg press, quadriceps muscle atrophy, performance in jump tests, and psychological readiness.
- Conditions
- Anterior Cruciate Ligament Reconstruction Rehabilitation, Anterior Cruciate Ligament Reconstruction
- Being tested
- Conventional Training, Eccentric Training
- Keywords
- Knee, Physiotherapy, Quadriceps, Anterior cruciate ligament reconstruction, Eccentric Exercise, Eccentric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional TrainingOther
Patients will execute the concentric and eccentric phases unilaterally, maintaining consistent load levels, with each phase lasting 2 seconds.
Eccentric TrainingOther
The concentric phase will be performed bilaterally in approximately 1 second, followed by the unilateral eccentric phase lasting approximately 3 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Training Group | Active comparator | Conventional concentric and eccentric phases Receives: Other: Conventional Training |
| Eccentric Training Group | Experimental | Focus on the eccentric phase of movement Receives: Other: Eccentric Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal isometric strength of knee extensors
Assessed by manual isometric dynamometry
Measured: In the 12th and 25th weeks post-surgery
Secondary outcomes (6)
Maximum isometric strength of knee flexors
Assessed by manual isometric dynamometry
Measured: In the 12th and 25th weeks post-surgery
Maximum dynamic strength during leg press exercise
Assessed through the 1 maximum repetition test (1RM)
Measured: In the 12th and 25th weeks post-surgery
Muscle atrophy
The evaluation of muscle atrophy will be performed by measuring the circumference of the thigh (cm)
Measured: In the 12th and 25th weeks post-surgery
Self-reported functional impairments
Self-reported functional impairments will be assessed using the International Knee Documentation Committee (IKDC)
Measured: In the 12th and 25th weeks post-surgery.
Performance in jump tests
Measured through the Single and Triple Hop Tests
Measured: In the 12th and 25th weeks post-surgery
Psychological readiness to return to sport
Assessed by Return to Sport after Anterior Cruciate Ligament Reconstruction Surgery (RSI-ACL)
Measured: In the 12th and 25th weeks post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start1 Mar 2025
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (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 Reconstruction RehabilitationStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Manfredini Baroni, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06905691
- Sponsor's protocol ID
- 77855224.0.0000.5345
- Status last verified
- Apr 2025
- First submitted
- 3 Apr 2024
- Last updated
- 24 Apr 2025
- 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 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Eccentric Training in the Rehabilitation of Patients Undergoing Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06905691
- Acronym / sponsor ID
- 77855224.0.0000.5345
- Conditions
- Anterior Cruciate Ligament Reconstruction Rehabilitation, Anterior Cruciate Ligament Reconstruction
- Keywords
- Knee, Physiotherapy, Quadriceps, Anterior cruciate ligament reconstruction, Eccentric Exercise, Eccentric
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Apr 2025 (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.
This study aims to investigate the effects of eccentric training on the functional rehabilitation of patients undergoing Anterior Cruciate Ligament Reconstruction (ACL-R). Thirty-four participants undergoing ACL-R will be randomly assigned to two groups: the Conventional Training Group (CTG) and the Eccentric Training Group (ETG). Both groups will adhere to the same post-surgical rehabilitation program, commencing in the first week after ACL-R and continuing until the criteria for sports resumption are achieved. The rehabilitation program will be structured into four phases: immediate post-operative, preparatory, general acquisition, and specific acquisition. The key distinction between the groups lies in their exercise regimen: ETG will prioritize the eccentric phase of movement, whereas CTG will engage in conventional exercises, maintaining uniform load across both movement phases. Assessment procedures will be conducted at three intervals for all participants: immediately post-operative, at 12 weeks post-ACL-R surgery (before the initiation of the training protocol), and at 25 weeks post-ACL-R surgery (upon completion of the training protocol). The primary outcome measure will be the maximum isometric strength of knee extensors. Secondary outcomes will encompass functional status, maximum isometric strength of knee flexors, peak dynamic strength during leg press, quadriceps muscle atrophy, performance in jump tests, and psychological readiness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Training Group | Active comparator | Other: Conventional TrainingConventional concentric and eccentric phases |
| Eccentric Training Group | Experimental | Other: Eccentric TrainingFocus on the eccentric phase of movement |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Individuals of both genders, aged between 18 and 40 years, scheduled for ACL reconstruction surgery during the data collection period.
Key exclusion criteria (2 listed)
- Delay of more than 7 days after surgery to initiate the rehabilitation program proposed by the study;
- Presence of injuries related to the rupture of the ACL that hinder partial weight-bearing in the first week after surgery, either due to medical recommendation or the patient inability/disposition.
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 |
|---|---|---|
| Conventional TrainingPatients will execute the concentric and eccentric phases unilaterally, maintaining consistent load levels, with each phase lasting 2 seconds. | Other | Conventional Training Group |
| Eccentric TrainingThe concentric phase will be performed bilaterally in approximately 1 second, followed by the unilateral eccentric phase lasting approximately 3 seconds. | Other | Eccentric Training Group |
Primary outcome
Maximal isometric strength of knee extensors
Time frame: In the 12th and 25th weeks post-surgery
Assessed by manual isometric dynamometry
6 secondary outcomes
Maximum isometric strength of knee flexors
Time frame: In the 12th and 25th weeks post-surgery
Maximum dynamic strength during leg press exercise
Time frame: In the 12th and 25th weeks post-surgery
Muscle atrophy
Time frame: In the 12th and 25th weeks post-surgery
Self-reported functional impairments
Time frame: In the 12th and 25th weeks post-surgery.
Performance in jump tests
Time frame: In the 12th and 25th weeks post-surgery
Psychological readiness to return to sport
Time frame: In the 12th and 25th weeks post-surgery.
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 24 Apr 2025.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Training and Eccentric Training in people with Anterior Cruciate Ligament Reconstruction Rehabilitation and Anterior Cruciate Ligament Reconstruction, run by Federal University of Health Science of Porto Alegre at 2 sites in Brazil.
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 1 inclusion and 2 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 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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 Gabriela Bissani Gasparin (+5554991296689, gabriela.gasparin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal isometric strength of knee extensors (time frame: In the 12th and 25th weeks post-surgery). 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 24 Apr 2025.