NCT02674282

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

October 31, 2016

Status Verified

October 1, 2016

Enrollment Period

2.9 years

First QC Date

February 1, 2016

Last Update Submit

October 27, 2016

Conditions

Anterior Cruciate Ligament Injury

Keywords

anterior cruciate ligament reconstructionanterior cruciate ligamentsports medicinesoccermaximum oxygen uptakereturn to play

Outcome Measures

Primary Outcomes (1)

  • Maximum oxygen uptake

    Ergospirometric evaluation of maximum oxygen uptake running on a treadmill

    6 months

Secondary Outcomes (4)

  • Running economy

    6 months

  • Body composition

    6 months

  • Isokinetic strength

    6 months

  • Knee function

    6 months

Study Arms (2)

ACL-injured

EXPERIMENTAL

ACL injured professional soccer players submitted to ACL reconstruction.

Procedure: ACL reconstruction

Control

NO INTERVENTION

Healthy professional soccer players

Interventions

ACL reconstructionPROCEDURE

ACL reconstruction with hamstrings autograft.

ACL-injured

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ACL injury
  • professional soccer player
  • adult
  • male

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Ortopedia e Traumatologia - HCFMUSP

São Paulo, São Paulo, 05403-010, Brazil

Location

Related 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. Epub 2014 Aug 25.

    PMID: 25157180BACKGROUND

  • 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.

    PMID: 11689745BACKGROUND

  • 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.

    PMID: 15974635BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Arnaldo J Hernandez, MD, PhD

    Department of Orthopedics and Traumatology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

February 1, 2016

First Posted

February 4, 2016

Study Start

January 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

October 31, 2016

Record last verified: 2016-10

Locations

BR(1)