Effects of Eccentric Training in the Rehabilitation of Patients Undergoing Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Trial

NCT06905691 | Recruiting

• 1 other identifier: 77855224.0.0000.5345
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

Brief 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 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

Keywords

Knee; Physiotherapy; Quadriceps; Anterior cruciate ligament reconstruction; Eccentric Exercise; Eccentric

Outcome Measures

Primary Outcomes (1)

• Maximal isometric strength of knee extensors

  Assessed by manual isometric dynamometry

  In the 12th and 25th weeks post-surgery

Secondary Outcomes (6)

• Maximum isometric strength of knee flexors

  In the 12th and 25th weeks post-surgery

• Maximum dynamic strength during leg press exercise

  In the 12th and 25th weeks post-surgery

• Muscle atrophy

  In the 12th and 25th weeks post-surgery

• Self-reported functional impairments

  In the 12th and 25th weeks post-surgery.

• Performance in jump tests

  In the 12th and 25th weeks post-surgery

Study Arms (2)

Conventional Training Group

ACTIVE COMPARATOR

Conventional concentric and eccentric phases

Other: Conventional Training

Eccentric Training Group

EXPERIMENTAL

Focus on the eccentric phase of movement

Other: Eccentric Training

Interventions

Conventional Training OTHER

Patients will execute the concentric and eccentric phases unilaterally, maintaining consistent load levels, with each phase lasting 2 seconds.

Conventional Training Group

Eccentric Training OTHER

The concentric phase will be performed bilaterally in approximately 1 second, followed by the unilateral eccentric phase lasting approximately 3 seconds.

Eccentric Training Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- Individuals of both genders, aged between 18 and 40 years, scheduled for ACL reconstruction surgery during the data collection period.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead

Study Sites (2)

Private Rehabilitation Center

Veranópolis, Rio Grande do Sul, 95330000, Brazil

NOT YET RECRUITING

Private Rehabilitation Center

Veranópolis, Rio Grande do Sul, 95330000, Brazil

RECRUITING

Central Study Contacts

Gabriela Bissani Gasparin

CONTACT

+5554991296689; gabriela.gasparin@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 1, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 24, 2025

Record last verified: 2025-04

Locations

BR (2)