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临床试验/NCT04748250
NCT04748250已完成不适用

Effect of Soy Phytoestrogens and Acupuncture on Bone Mineral Density in Female Athlete Triad at Adolescence Age

Hend Reda Sakr2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年7月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Bone Mineral Density

研究概览

简要总结

The aim of this study to determine the effect of soy phytoestrogens and acupuncture on osteoporosis in female athlete triad at adolescence age. It is hypothesized that:

  • There will be no statistical significant difference between the effects of soy phytoestrogens and acupuncture on osteoporosis in female athlete triad at adolescence age. RESEARCH QUESTION: Do soy phytoestrogens and acupuncture have an effect on bone mineral density in female athlete triad at adolescence age?

详细描述

Many female athletes don't depend only on physical training and exercising to obtain the ideal slim and thin body. So that they follow harmful unhealthy diet to achieve the ideal body shape they are seeking. These types of diet can lead to malnutrition, menstrual disturbances, and bone loss, and these three components form a triad called female athlete triad. A limited number of studies have examined the effect of acupuncture and soy products on irregularities related to female athletes so the aim of this study is to investigate the effect of both acupuncture in line with diet modification using soy products on osteopenia in female athlete triad. Study Design: A prospective, randomized, single-blind, pre-post-test, controlled trial.

Sixty female athletes with ages ranged from 14 to 18 years, playing gymnastics and all diagnosed and referred with female athlete triad resulting in decreased bone mineral density and osteoporosis. All participants will be treated with soy products and acupuncture and will be closely followed for six months. DEXA will be used to assess bone mineral density before and after the treatment program.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
14 Years 至 18 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • All girls diagnosed with female athlete triad resulting in osteopenia
  • Their age between 14-18 years old
  • Their body mass index is less than 5 percent according to the gross motor chart
  • All participants are gymnastics players
  • All are medically stable
  • They will be able to follow instructions

排除标准

  • Pregnancy
  • Taking any hormonal treatment
  • Receiving any other form of traditional physical therapy modalities

结局指标

主要结局

Bone Mineral Density

时间窗: Six months

DEXA(Dual-energy X-ray absorptiometry)

次要结局

未报告次要终点

研究者

发起方
Hend Reda Sakr
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hend Reda Sakr

Principal investigator and Lecturer at Department of Physical Therapy for Woman's Health

Badr University

研究点 (2)

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