Promotion and Protection of the Well Being of Women Athletes Through the Female Athlete Triad Screening
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 主要终点
- Quality of life through a validated in Italian (SF-12) and a screening questionnaire recommended by the Female Athlete Triad Expert Panel.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •age between 14 and 40 years;
- •absence of malignancies;
- •informed consent obtained from the patient;
- •no previous surgical, chemotherapic and/or radiotherapic treatments.
排除标准
- •recent traumas;
- •recent surgeries;
- •oncologic history;
- •uncontrolled systemic illnesses;
- •severe or uncontrolled infection;
- •mental illness;
结局指标
主要结局
Quality of life through a validated in Italian (SF-12) and a screening questionnaire recommended by the Female Athlete Triad Expert Panel.
时间窗: 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.
次要结局
- correlation between altered screening questionnaire and a clinical dysfunction(day 1 and through completion of work-up, average 1 month.)
- Incidence and prevalence of gynecological disorders in female athletes(day 1 and through completion of work-up, average 1 month.)
研究者
Roberto Angioli
Professor
Campus Bio-Medico University