- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07587346
The Impact of Whole-Body Vibration and Relaxation Techniques on Adolescent Athlete Girls With Triad Syndrome" (WBV for triad)
This study aims to explore the effects of Whole-Body Vibration (WBV) exercises and relaxation techniques on adolescent female athletes who are experiencing Female Athlete Triad Syndrome - a condition that may include low bone density, irregular menstrual cycles, and low energy availability.
Participants will take part in a structured program combining vibration training and relaxation sessions over several weeks. The goal is to determine whether this combination can improve bone health, menstrual regularity, physical performance, and overall well-being in young female athletes.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
The Female Athlete Triad is a medical condition commonly observed in adolescent female athletes and is characterized by three interrelated components: low energy availability (with or without an eating disorder), menstrual dysfunction, and decreased bone mineral density. These factors can negatively affect growth, performance, and long-term health.
This randomized controlled study aims to investigate the combined effects of Whole-Body Vibration (WBV) training and relaxation techniques on adolescent athlete girls diagnosed with the Female Athlete Triad Syndrome.
Participants will be divided into two groups : study group will receive WBV and relaxation training and control group will receive relaxation technique only. The intervention will be conducted for 8 weeks under the supervision of a physiotherapist.
Primary outcomes will include changes in bone mineral density and hormonal regulation. Secondary outcomes will assess psychological well-being.
This study seeks to provide evidence on the potential benefits of combining WBV and relaxation techniques to support bone health, hormonal regulation, and physical and mental recovery among adolescent female athletes.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: shaimaa MH elmarakby
- Номер телефона: 01008585299
- Электронная почта: shaimaa.mohamed@pt.mti.edu.eg
Места учебы
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Cairo, Египет
- Рекрутинг
- Mti
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Контакт:
- shaimaa MH elmarakby
- Номер телефона: 01008585299
- Электронная почта: shaimaa.mohamed@pt.mti.edu.eg
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Low energy availability (with or without disordered eating)
- Menstrual dysfunction (oligomenorrhea)
- Low bone mineral density or a history of stress fractures
Exclusion criteria:
- Recent fractures or unhealed stress fractures within the last 6 months.
- Presence of serious medical conditions that contraindicate WBV or exercise participation, such as: Uncontrolled cardiovascular disease, Uncontrolled hypertension, Neurological disorders, Severe vestibular disorders, Active cancer, Bleeding/clotting disorders.
- Severe eating disorder requiring inpatient medical or psychiatric treatment.
- Current use of medications that significantly affect bone or hormonal status
- Participation in another interventional clinical study within the last 3 months.
- Inability or unwillingness to provide assent/consent or comply with study procedures.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Whole body vibration
group A contains 25 Participants in this group will receive Whole-Body Vibration (WBV) combined with Relaxation training three times per week for 8 weeks.
Each session will include static and dynamic exercises performed on a vibration platform under physiotherapist supervision.
The intervention aims to improve bone mineral density and hormonal regulation in adolescent athlete girls with Female Athlete Triad Syndrome.
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Participants in study group will receive a combination of Whole-Body Vibration (WBV) training and relaxation techniques during the same intervention period. Each session will include approximately 15-20 minutes of WBV exercises performed on a vibration platform under physiotherapist supervision, followed by 20-30 minutes of guided relaxation training involving deep breathing, progressive muscle relaxation, and mindfulness-based relaxation. The sessions will be conducted three times per week for 8 weeks. In control group participant will receive relaxation techniques the program will include a combination of guided breathing exercises, progressive muscle relaxation, and mindfulness-based relaxation.Each session will last about 20-30 minutes, conducted three times per week for 8 weeks, supervised by a physiotherapist or psychologist trained in relaxation therapy. for both groups (A&B) will receive relaxation Techniques Training The program may include:
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Экспериментальный: Relaxation training
group B contain 25 Participants will receive guided relaxation training three times per week for 8 weeks.
Each session will include deep breathing exercises, progressive muscle relaxation, and mindfulness-based relaxation, supervised by a physiotherapist.
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for both groups (A&B) will receive relaxation Techniques Training The program may include:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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hormonal regularity
Временное ограничение: 2 months
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hormonal regularity via Estrogen serum analysis It involves measuring the levels of estrogens (primarily estradiol) in the blood to evaluate reproductive health, menstrual cycle function, fertility, menopause status, or hormonal disorders.
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2 months
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bone mineral density
Временное ограничение: 2 months
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bone mineral density via DEXA.
that used to diagnose osteoporosis, assess fracture risk, and monitor changes in bone over time.
The gold standard for assessing BMD is the DEXA scan (also known as DXA, or Dual-Energy X-ray Absorptiometry).
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2 months
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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psychological well-being
Временное ограничение: 2 months
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psychological well-being via Hamilton Anxiety Rating Scale (HAM-A) (Hamilton, 1959) This scale measures the anxiety symptoms severity.
It has 14 items and series of symptoms define every item.
5 point Likert scale is used to rate each item i.e. (1) never, (2) rarely, (3) sometimes, (4) very often, (5) always.
Mild anxiety is indicated by lowest score and the highest scores indicate severe anxiety.
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2 months
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Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- REC/2111/MTI.PT/2511401
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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