Maximum Oxygen Uptake in ACL-injured Professional Soccer Players
Primary Purpose
Anterior Cruciate Ligament Injury
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
ACL reconstruction
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Cruciate Ligament Injury focused on measuring anterior cruciate ligament reconstruction, anterior cruciate ligament, sports medicine, soccer, maximum oxygen uptake, return to play
Eligibility Criteria
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
Sites / Locations
- Instituto de Ortopedia e Traumatologia - HCFMUSP
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
ACL-injured
Control
Arm Description
ACL injured professional soccer players submitted to ACL reconstruction.
Healthy professional soccer players
Outcomes
Primary Outcome Measures
Maximum oxygen uptake
Ergospirometric evaluation of maximum oxygen uptake running on a treadmill
Secondary Outcome Measures
Running economy
Running economy evaluated on a treadmill
Body composition
Evaluation of body composition with bioimpedance
Isokinetic strength
Quadriceps and hamstrings isokinetic strength evaluation
Knee function
Knee function Lysholm and International Knee Documentation Committee questionnaires
Full Information
NCT ID
NCT02674282
First Posted
February 1, 2016
Last Updated
October 27, 2016
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02674282
Brief Title
Maximum Oxygen Uptake in ACL-injured Professional Soccer Players
Official Title
Maximum Oxygen Uptake in ACL-injured Professional Soccer Players
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injury
Keywords
anterior cruciate ligament reconstruction, anterior cruciate ligament, sports medicine, soccer, maximum oxygen uptake, return to play
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ACL-injured
Arm Type
Experimental
Arm Description
ACL injured professional soccer players submitted to ACL reconstruction.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Healthy professional soccer players
Intervention Type
Procedure
Intervention Name(s)
ACL reconstruction
Intervention Description
ACL reconstruction with hamstrings autograft.
Primary Outcome Measure Information:
Title
Maximum oxygen uptake
Description
Ergospirometric evaluation of maximum oxygen uptake running on a treadmill
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Running economy
Description
Running economy evaluated on a treadmill
Time Frame
6 months
Title
Body composition
Description
Evaluation of body composition with bioimpedance
Time Frame
6 months
Title
Isokinetic strength
Description
Quadriceps and hamstrings isokinetic strength evaluation
Time Frame
6 months
Title
Knee function
Description
Knee function Lysholm and International Knee Documentation Committee questionnaires
Time Frame
6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaldo J Hernandez, MD, PhD
Organizational Affiliation
Department of Orthopedics and Traumatology
Official's Role
Study Director
Facility Information:
Facility Name
Instituto de Ortopedia e Traumatologia - HCFMUSP
City
São Paulo
ZIP/Postal Code
05403-010
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25157180
Citation
Ardern CL, Taylor NF, Feller JA, Webster KE. Fifty-five per cent return to competitive sport following anterior cruciate ligament reconstruction surgery: an updated systematic review and meta-analysis including aspects of physical functioning and contextual factors. Br J Sports Med. 2014 Nov;48(21):1543-52. doi: 10.1136/bjsports-2013-093398. Epub 2014 Aug 25.
Results Reference
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PubMed Identifier
11689745
Citation
Helgerud J, Engen LC, Wisloff U, Hoff J. Aerobic endurance training improves soccer performance. Med Sci Sports Exerc. 2001 Nov;33(11):1925-31. doi: 10.1097/00005768-200111000-00019.
Results Reference
background
PubMed Identifier
15974635
Citation
Stolen T, Chamari K, Castagna C, Wisloff U. Physiology of soccer: an update. Sports Med. 2005;35(6):501-36. doi: 10.2165/00007256-200535060-00004.
Results Reference
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Maximum Oxygen Uptake in ACL-injured Professional Soccer Players
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