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?
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Primary Purpose: Treatment
- Masking: Single (Outcomes Assessor)
- Study Primary Completion Date: February 10, 2021
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 three months. DEXA will be used to assess bone mineral density before and after the treatment program.
- Device: Acupuncture needles
- Standard acupuncture needle which is 3 cm long with diameter o.3 mm
- Dietary Supplement: Soy phytoestrogens
- 100 millilitre of soy milk every day or 100 gram of cooked soy beans per day.
Arms, Groups and Cohorts
- Experimental: Acupuncture Group
- This group will receive acupuncture therapy for 30 minutes, three times per week for three months using the internationally recognized standard acupuncture needle which is 3 cm long with diameter o.3 mm, pushing it with twisting movement to the required depth until the De Qi sensation will be obtained.
- Experimental: Soy Group
- This group will receive soy products for three months which including: Soy milk: 100 millilitre of soy milk every day, every bottle of original soy milk contains 300 millilitre or Soy beans: 100 gram of cooked soy beans per day.
- Experimental: Acupuncture and Soy Group
- Every patient in this group will receive acupuncture therapy sessions in abdominal acu-points as in group (A) for 30 minutes, three times per week for three months in addition to administration of soy products in the form of soy milk or soy beans daily in breakfast for three months as in group (B).
Clinical Trial Outcome Measures
- Bone Mineral Density
- Time Frame: Three months
- DEXA(Dual-energy X-ray absorptiometry)
Participating in This Clinical Trial
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 Exclusion Criteria:
- Marriage – Pregnancy – Taking any hormonal treatment – Receiving any other form of traditional physical therapy modalities
Gender Eligibility: Female
Minimum Age: 14 Years
Maximum Age: 18 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Hend Reda Sakr
- Provider of Information About this Clinical Study
- Sponsor-Investigator: Hend Reda Sakr, Principal investigator and Lecturer at Department of Physical Therapy for Woman’s Health – Badr University
- Overall Official(s)
- Hend Reda, PhD, Study Director, Badr University in Cairo
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