Maximum Oxygen Uptake in ACL-injured Professional Soccer... | NCT02674282

Studies
Maximum Oxygen Uptake in ACL-injured Professional Soccer Players

NCT02674282

Sponsor

University of Sao Paulo

Status

Unknown status

Last Update Posted

Oct 31, 2016Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Anterior Cruciate Ligament Injury

Interventions

ACL reconstruction

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Dec 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Feb 1, 2016

First Submission Date that Met QC Criteria

Feb 1, 2016

First Posted Date

Feb 4, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 27, 2016

Last Update Posted Date

Oct 31, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Adriano Marques de Almeida, Medical Doctor, University of Sao PauloPrincipal Investigator

Lead Sponsor

University of Sao PauloOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ACL-injured	Experimental	ACL injured professional soccer players submitted to ACL reconstruction.	Procedure: ACL reconstruction
Control	No Intervention	Healthy professional soccer players

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ACL reconstruction	Procedure	ACL reconstruction with hamstrings autograft.	ACL-injured

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Running economy	Running economy evaluated on a treadmill	6 months
Body composition	Evaluation of body composition with bioimpedance

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arnaldo J Hernandez, MD, PhD	Department of Orthopedics and Traumatology	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto de Ortopedia e Traumatologia - HCFMUSP		São Paulo	São Paulo	05403-010	Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25157180	Background	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.
11689745

Type	Date	Date Unknown
Release	May 16, 2018
Reset	Dec 7, 2018
Release	Dec 7, 2018
Reset	Mar 15, 2019

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
May 16, 2018			Dec 7, 2018
Dec 7, 2018

ID	Term
D007718	Knee Injuries
D007869	Leg Injuries
D014947	Wounds and Injuries