NCT03171285

Brief Summary

Although the mortality rate among soccer players is low, it causes much impact on the entire community and is a fascinating conundrum. The aim of this study was to evaluate the cardiovascular risk of soccer referees, to describe the frequency of cardiovascular risk considering age groups younger and older than 35 years old and to relate the Framingham and PROCAM indices for the comparison of cardiovascular risk in soccer referees. 50 referees of Paulista Soccer Federation were subjected to clinical and laboratory based evaluations at the Center for Sports Health at the Faculty of Medicine of ABC, and divided into two groups: lower and higher than 35 years of age.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2009

Completed
7.5 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 31, 2017

Completed
Last Updated

June 2, 2017

Status Verified

May 1, 2017

Enrollment Period

7 months

First QC Date

May 27, 2017

Last Update Submit

May 31, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Higher risk for coronary artery disease in referees aged over 35 years old.

    Higher risk for coronary artery disease in referees aged over 35 years old assessed by clinical and laboratory evaluations.

    7 months

Study Arms (2)

Less than 35 years old

Clinical and laboratory evaluations

Other: Less than 35 years old

Greater than or equal to 35 years

Clinical and laboratory evaluations

Other: Greater than or equal to 35 years

Interventions

Clinical and laboratory evaluations

Less than 35 years old

Clinical and laboratory evaluations

Greater than or equal to 35 years

Eligibility Criteria

Age25 Years - 44 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

50 high performance field soccer referees of the Paulista Soccer Federation (PFF), during a pre-season training period of the 2009 Brazilian soccer championship.

You may qualify if:

  • elite referees of the gold series of the Paulista Soccer Federation;
  • registered for participation in the São Paulo professional soccer championship in 2009;
  • eligible for pre-participative evaluation and have completed the entire series of tests considered indispensable for the present study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escola de Artes,Ciencias e Humanidades da Universidade d Sao Paulo

São Paulo, 03828-000, Brazil

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Carlos BM Monteiro, Ph.D.

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 27, 2017

First Posted

May 31, 2017

Study Start

May 2, 2009

Primary Completion

December 12, 2009

Study Completion

December 12, 2009

Last Updated

June 2, 2017

Record last verified: 2017-05

Locations