Anterior Cruciate Ligament InjuryNCT02674282
Maximum Oxygen Uptake in ACL-injured Professional Soccer Players
A study testing ACL reconstruction in people with Anterior Cruciate Ligament Injury, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Injury
- What is being tested?
- ACL reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- ACL injury
- professional soccer player
- adult
- male
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Ortopedia e Traumatologia - HCFMUSP
São Paulo, São Paulo, 05403-010
About this study
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.
Read the 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.
- Conditions
- Anterior Cruciate Ligament Injury
- Being tested
- ACL reconstruction
- Keywords
- anterior cruciate ligament reconstruction, anterior cruciate ligament, sports medicine, soccer, maximum oxygen uptake, return to play
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACL reconstructionProcedure or surgery
ACL reconstruction with hamstrings autograft.
| Study group | Role | What they receive |
|---|---|---|
| ACL-injured | Experimental | ACL injured professional soccer players submitted to ACL reconstruction. Receives: Procedure: ACL reconstruction |
| Control | No intervention | Healthy professional soccer players |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum oxygen uptake
Ergospirometric evaluation of maximum oxygen uptake running on a treadmill
Measured: 6 months
Secondary outcomes (4)
Running economy
Running economy evaluated on a treadmill
Measured: 6 months
Body composition
Evaluation of body composition with bioimpedance
Measured: 6 months
Isokinetic strength
Quadriceps and hamstrings isokinetic strength evaluation
Measured: 6 months
Knee function
Knee function Lysholm and International Knee Documentation Committee questionnaires
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study startJan 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuryStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adriano Marques de Almeida, University of Sao Paulo
- Investigators
- Arnaldo J Hernandez, MD, PhD, Study director, Department of Orthopedics and Traumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02674282
- Sponsor's protocol ID
- IOT983
- Status last verified
- Oct 2016
- First submitted
- 1 Feb 2016
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25157180Helgerud 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.
PubMed 11689745Stolen 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.
PubMed 15974635
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximum Oxygen Uptake in ACL-injured Professional Soccer Players
- ClinicalTrials.gov ID
- NCT02674282
- Acronym / sponsor ID
- IOT983
- Conditions
- Anterior Cruciate Ligament Injury
- Keywords
- anterior cruciate ligament reconstruction, anterior cruciate ligament, sports medicine, soccer, maximum oxygen uptake, return to play
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 4 Feb 2016 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACL-injured | Experimental | Procedure: ACL reconstructionACL injured professional soccer players submitted to ACL reconstruction. |
| Control | No intervention | –Healthy professional soccer players |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ACL injury
- professional soccer player
- adult
- male
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| ACL reconstructionACL reconstruction with hamstrings autograft. | Procedure or surgery | ACL-injured |
Primary outcome
Maximum oxygen uptake
Time frame: 6 months
Ergospirometric evaluation of maximum oxygen uptake running on a treadmill
4 secondary outcomes
Running economy
Time frame: 6 months
Body composition
Time frame: 6 months
Isokinetic strength
Time frame: 6 months
Knee function
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
- Background: PubMed 25157180Ardern 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.
- Background: PubMed 11689745Helgerud 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.
- Background: PubMed 15974635Stolen 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.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Arnaldo J Hernandez, MD, PhD study director
Department of Orthopedics and Traumatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACL reconstruction in people with Anterior Cruciate Ligament Injury, run by University of Sao Paulo at 1 site 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 31 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum oxygen uptake (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02674282, which also lists 3 linked publications.
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 31 Oct 2016.