- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06905691
Effects of Eccentric Training in the Rehabilitation of Patients Undergoing Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Trial
April 22, 2025 updated by: Bruno Manfredini Baroni, Federal University of Health Science of Porto Alegre
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 Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gabriela Bissani Gasparin
- Phone Number: +5554991296689
- Email: gabriela.gasparin@hotmail.com
Study Locations
-
-
RS
-
Veranópolis, RS, Brazil, 95330000
- Not yet recruiting
- Private Rehabilitation Center
-
Principal Investigator:
- Gabriela Bissani Gasparin
-
Contact:
- Gabariela Bissani Gasparin
- Phone Number: +5554991296689
- Email: gabriela.gasparin@hotmail.com
-
Veranópolis, RS, Brazil, 95330000
- Recruiting
- Private Rehabilitation Center
-
Contact:
- Gabariela Bissani Gasparin
- Phone Number: 54991296689
- Email: gabriela.gasparin@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Individuals of both genders, aged between 18 and 40 years, scheduled for ACL reconstruction surgery during the data collection period.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Conventional Training Group
Conventional concentric and eccentric phases
|
Patients will execute the concentric and eccentric phases unilaterally, maintaining consistent load levels, with each phase lasting 2 seconds.
|
|
Experimental: Eccentric Training Group
Focus on the eccentric phase of movement
|
The concentric phase will be performed bilaterally in approximately 1 second, followed by the unilateral eccentric phase lasting approximately 3 seconds.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximal isometric strength of knee extensors
Time Frame: In the 12th and 25th weeks post-surgery
|
Assessed by manual isometric dynamometry
|
In the 12th and 25th weeks post-surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximum isometric strength of knee flexors
Time Frame: In the 12th and 25th weeks post-surgery
|
Assessed by manual isometric dynamometry
|
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
|
Assessed through the 1 maximum repetition test (1RM)
|
In the 12th and 25th weeks post-surgery
|
|
Muscle atrophy
Time Frame: In the 12th and 25th weeks post-surgery
|
The evaluation of muscle atrophy will be performed by measuring the circumference of the thigh (cm)
|
In the 12th and 25th weeks post-surgery
|
|
Self-reported functional impairments
Time Frame: In the 12th and 25th weeks post-surgery.
|
Self-reported functional impairments will be assessed using the International Knee Documentation Committee (IKDC)
|
In the 12th and 25th weeks post-surgery.
|
|
Performance in jump tests
Time Frame: In the 12th and 25th weeks post-surgery
|
Measured through the Single and Triple Hop Tests
|
In the 12th and 25th weeks post-surgery
|
|
Psychological readiness to return to sport
Time Frame: In the 12th and 25th weeks post-surgery.
|
Assessed by Return to Sport after Anterior Cruciate Ligament Reconstruction Surgery (RSI-ACL)
|
In the 12th and 25th weeks post-surgery.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2025
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
April 3, 2024
First Submitted That Met QC Criteria
March 31, 2025
First Posted (Actual)
April 1, 2025
Study Record Updates
Last Update Posted (Actual)
April 24, 2025
Last Update Submitted That Met QC Criteria
April 22, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 77855224.0.0000.5345
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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