Promotion of Wellbeing in Women Athletes

NCT03064230 | Completed

• 1 other identifier: 25/15 OSS ComEt CBM
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Quality of Life

Outcome Measures

Primary Outcomes (1)

• Quality of life through a validated in Italian (SF-12) and a screening questionnaire recommended by the Female Athlete Triad Expert Panel.

  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.

  day 1 at time of the visit. no follow/up

Secondary Outcomes (2)

• 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.

Study Arms (2)

Athletes agonists (Experimental Group)

I) age between 14 and 40 years who met the definition of competitive sports athletes adopted by the Italian Ministry of Health II) absence of malignancies; III) informed consent obtained from the patient; IV) no previous surgical, chemotherapic and/or radiotherapic treatments. We 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. QoL questionnaire SF-12 and and a screening questionnaire were requested

Other: QoL questionnaire SF-12 and and a screening questionnaire

women not agonists (Control Group)

I) age between 14 and 40 years who did not met the definition of competitive sports athletes adopted by the Italian Ministry of Health; II) absence of malignancies; III) informed consent obtained from the patient; IV) no previous surgical, chemotherapic and/or radiotherapic treatments. We 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. QoL questionnaire SF-12 and and a screening questionnaire were requested

Other: QoL questionnaire SF-12 and and a screening questionnaire

Interventions

QoL questionnaire SF-12 and and a screening questionnaire OTHER

patient were asked to fill questionnaires

Athletes agonists (Experimental Group); women not agonists (Control Group)

Eligibility Criteria

• Age: 14 Years - 40 Years
• Gender Eligibility Details: evaluation of well being in female athletes and evaluation of gynecologic dysfunctions
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Women aged between 14 and 40 years, who came to undergo routine physical examination.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)and women who do not perform any agonistic sports(Control Group). Were considered agonists athletes all the patients who met the definition of competitive sports athletes adopted by the Italian Ministry of Health:"form of sporting activity systematically and/or continually practiced, especially organized by the National Sports Federations with regard to the Youth Games at National level, to the achievement of a certain level of sportive performance".All other women were included in the control group.

You may qualify if:

• age between 14 and 40 years;
• absence of malignancies;
• informed consent obtained from the patient;
• no previous surgical, chemotherapic and/or radiotherapic treatments.

You may not qualify if:

• recent traumas;
• recent surgeries;
• oncologic history;
• uncontrolled systemic illnesses;
• severe or uncontrolled infection;
• mental illness;
• pregnancy.

Sponsors & Collaborators

• Campus Bio-Medico University: lead
• Federazione medicina sportiva italiana (FMSI): collaborator

Related Publications (1)

• Joy E, De Souza MJ, Nattiv A, Misra M, Williams NI, Mallinson RJ, Gibbs JC, Olmsted M, Goolsby M, Matheson G, Barrack M, Burke L, Drinkwater B, Lebrun C, Loucks AB, Mountjoy M, Nichols J, Borgen JS. 2014 female athlete triad coalition consensus statement on treatment and return to play of the female athlete triad. Curr Sports Med Rep. 2014 Jul-Aug;13(4):219-32. doi: 10.1249/JSR.0000000000000077.

  PMID: 25014387 RESULT

Related Links

• female athlete triad

Study Officials

• Roberto Angioli

  University Campus Bio Medico of Rome

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 19, 2017
• First Posted: February 27, 2017
• Study Start: January 1, 2016
• Primary Completion: May 30, 2016
• Study Completion: May 30, 2016
• Last Updated: February 27, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share