Maximum Oxygen Uptake in ACL-injured Professional Soccer Players

Anterior Cruciate Ligament Injury Clinical Trial

Official title:

Maximum Oxygen Uptake in ACL-injured Professional Soccer Players

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02674282
• Other study ID #: IOT983
• Status: Active, not recruiting
• Phase: N/A
• First received: February 1, 2016
• Last updated: October 27, 2016
• Start date: January 2014
• Est. completion date: December 2016

Study information

• Verified date: October 2016
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injury

Intervention

Procedure:
• ACL reconstruction
ACL reconstruction with hamstrings autograft.

Locations

Country	Name	City	State
Brazil	Instituto de Ortopedia e Traumatologia - HCFMUSP	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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. Review. — View 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. — View Citation

Stølen T, Chamari K, Castagna C, Wisløff U. Physiology of soccer: an update. Sports Med. 2005;35(6):501-36. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum oxygen uptake	Ergospirometric evaluation of maximum oxygen uptake running on a treadmill	6 months	No
Secondary	Running economy	Running economy evaluated on a treadmill	6 months	No
Secondary	Body composition	Evaluation of body composition with bioimpedance	6 months	No
Secondary	Isokinetic strength	Quadriceps and hamstrings isokinetic strength evaluation	6 months	No
Secondary	Knee function	Knee function Lysholm and International Knee Documentation Committee questionnaires	6 months	No