Clinical Trial: Promotion of Wellbeing in Women Athletes

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Promotion and Protection of the Well Being of Women Athletes Through the Female Athlete Triad Screening

Brief Summary:

The Female Athlete Triad is a medical condition often observed in physically active girls and women, and involves 3 components: (1) low energy availability with or without disordered eating, (2) menstrual dysfunction, and (3) low bone mineral density. An early intervention is essential to prevent its progression to serious endpoints including clinical eating disorders, amenorrhea, and osteoporosis that can affect the quality of life of these patients and even compromise the athletic performance.

All patients, aged between 14 and 40 years, who met the inclusion and exclusion criteria, were prospectively enrolled in this observational study and were divided into two groups: Athletes agonists (Experimental Group or Group A) and women who do not perform agonistic sports (Control Group or Group B). In both groups of patients, the investigators administered two types of questionnaires: a standardized quality of Life questionnaire, validated in Italian (SF-12) and a screening questionnaire recommended by the Female Athlete Triad Expert Panel.


Detailed Summary:

From January 2016 to May 2016 the investigators considered eligible all consecutive women, aged between 14 and 40 years, who came to undergo routine physical examination.

The institutional internal review board approved the study. Inclusion criteria were: I) age between 14 and 40 years; II) absence of malignancies; III) informed consent obtained from the patient; IV) no previous surgical, chemotherapic and/or radiotherapic treatments.

the investigators excluded all patients who presented any conditions that could alter quality of life such as: I) recent traumas; II) recent surgeries; III) oncologic history; IV) uncontrolled systemic illnesses; V) severe or uncontrolled infection; VI) mental illness; VII) pregnancy.

All patients who met the inclusion and exclusion criteria were prospectively enrolled in this observational study and were divided into two groups: Athletes agonists (Experimental Group or Group A) and women who do not perform any agonistic sports (Control Group or Group B).

Were considered agonists athletes and enrolled in Group A all the patients who met the definition of competitive sports athletes adopted by the Italian Ministry of Health (Ministerial Decree, D.M. 18/02/1982 - Circular No. 7 of 01/31/1983): "form of sporting activity systematically and/or continually practiced, especially organized by the National Sports Federations, the Sporting Promotion bodies recognized both by CONI and the Ministry of Education with regard to the Youth Games at National level, to the achievement of a certain level of sportive performance". All other women were considered as not athletes and were included in the control group (Group B).

To assess the sample size,
Sponsor: Campus Bio-Medico University

Current Primary Outcome: Quality of life through a validated in Italian (SF-12) and a screening questionnaire recommended by the Female Athlete Triad Expert Panel. [ Time Frame: day 1 at time of the visit. no follow/up ]

SF-12 questionnaire is a reliable measure of perceived health that describes the degree of general physical health status and mental health distress. It consists of 12 items, derived from the physical and mental domains. In our study SF-12 was considered altered if the score was <40, either from the physical or mental functioning point of view, because means of 50 and standard deviations of 10 are usually achieved in the general population.

the athlete triad screening questionnaire was focused on those main risk factors that can lead to a decreased quality of life in women and to an early detection of a medical dysfunction related to the female triad. In our study we evaluated two cut-off to consider the questionnaire altered: 1) alteration of at least two items of the questionnaire; 2) alteration of at least two items of the questionnaire, where question 6,7 and 8 (all related to eating disorders) were considered as one.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • correlation between altered screening questionnaire and a clinical dysfunction [ Time Frame: day 1 and through completion of work-up, average 1 month. ]
    If either one of the two questionnaire resulted altered (SF-12 or screening questionnaire), or would arise any suspicion from the physical evaluation, the patient was sent to a more in-depth assessment in order to verify the presence of a clinical dysfunction.
  • Incidence and prevalence of gynecological disorders in female athletes [ Time Frame: day 1 and through completion of work-up, average 1 month. ]
    We compared our results within the two groups to assess if there were any differences in terms of incidence or prevalence of gynecologic disfunctions


Original Secondary Outcome: Same as current

Information By: Campus Bio-Medico University

Dates:
Date Received: February 19, 2017
Date Started: January 1, 2016
Date Completion:
Last Updated: February 24, 2017
Last Verified: February 2017