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- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: shaimaa MH elmarakby
- Numéro de téléphone: 01008585299
- E-mail: shaimaa.mohamed@pt.mti.edu.eg
Lieux d'étude
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Cairo, Egypte
- Recrutement
- Mti
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Contact:
- shaimaa MH elmarakby
- Numéro de téléphone: 01008585299
- E-mail: shaimaa.mohamed@pt.mti.edu.eg
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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hormonal regularity
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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psychological well-being
Délai: 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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Collaborateurs et enquêteurs
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Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- REC/2111/MTI.PT/2511401
Informations sur les médicaments et les dispositifs, documents d'étude
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