- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: shaimaa MH elmarakby
- Numero di telefono: 01008585299
- Email: shaimaa.mohamed@pt.mti.edu.eg
Luoghi di studio
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Cairo, Egitto
- Reclutamento
- Mti
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Contatto:
- shaimaa MH elmarakby
- Numero di telefono: 01008585299
- Email: shaimaa.mohamed@pt.mti.edu.eg
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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hormonal regularity
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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psychological well-being
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- REC/2111/MTI.PT/2511401
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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