Maximum Oxygen Uptake in ACL-injured Professional Soccer Players

October 27, 2016 updated by: Adriano Marques de Almeida, University of Sao Paulo
Our purpose is to evaluate maximum oxygen uptake (VO2max) in ACL-injured professional soccer players and after a six-month period of post-operative rehabilitation, compared to a control group of healthy professional soccer players.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The anterior cruciate ligament (ACL) rupture is considered a major injury and may affect the career of professional soccer players. Surgical ACL reconstruction is often required to treat the resulting knee instability. Although ACL reconstruction is considered a successful procedure in restoring knee stability, literature shows that only 55% of the participants return to competitive sports participation after surgery. Soccer players need technical, tactical and physical skills to succeed, such as good knee function and aerobic capacity. Our purpose is to evaluate maximum oxygen uptake (VO2max) in ACL-injured professional soccer players and after a six-month period of post-operative rehabilitation, compared to a control group of healthy professional soccer players.

Study Type

Interventional

Enrollment (Actual)

20

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 Locations

  • Brazil
      • São Paulo, Brazil, 05403-010
        • Instituto de Ortopedia e Traumatologia - HCFMUSP

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

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • ACL injury
  • professional soccer player
  • adult
  • male

Exclusion Criteria:

  • Multiple ligament injury
  • knee effusion
  • unable to perform the examination on the treadmill
  • ACL reconstruction failure
  • reoperation due to any cause during the follow-up period
  • goalkeeper

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ACL-injured
ACL injured professional soccer players submitted to ACL reconstruction.
Procedure: ACL reconstruction
ACL reconstruction with hamstrings autograft.
No Intervention: Control
Healthy professional soccer players

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum oxygen uptake
Time Frame: 6 months
Ergospirometric evaluation of maximum oxygen uptake running on a treadmill
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Running economy
Time Frame: 6 months
Running economy evaluated on a treadmill
6 months
Body composition
Time Frame: 6 months
Evaluation of body composition with bioimpedance
6 months
Isokinetic strength
Time Frame: 6 months
Quadriceps and hamstrings isokinetic strength evaluation
6 months
Knee function
Time Frame: 6 months
Knee function Lysholm and International Knee Documentation Committee questionnaires
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Study Director: Arnaldo J Hernandez, MD, PhD, Department of Orthopedics and Traumatology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

February 1, 2016

First Submitted That Met QC Criteria

February 1, 2016

First Posted (Estimate)

February 4, 2016

Study Record Updates

Last Update Posted (Estimate)

October 31, 2016

Last Update Submitted That Met QC Criteria

October 27, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IOT983

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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