NCT07587346

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 14, 2026

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2026

Completed
Last Updated

May 14, 2026

Status Verified

May 1, 2026

Enrollment Period

2 months

First QC Date

May 1, 2026

Last Update Submit

May 8, 2026

Conditions

Keywords

Athelte traid , whole body vibration , relaxation technique

Outcome Measures

Primary Outcomes (2)

  • hormonal regularity

    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.

    2 months

  • bone mineral density

    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).

    2 months

Secondary Outcomes (1)

  • psychological well-being

    2 months

Study Arms (2)

Whole body vibration

EXPERIMENTAL

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.

Device: whole body vibration deviceOther: relaxation training

Relaxation training

EXPERIMENTAL

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.

Other: relaxation training

Interventions

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.

Whole body vibration

for both groups (A\&B) will receive relaxation Techniques Training The program may include: 1. Diaphragmatic (Deep) Breathing Focus on slow, controlled breathing from the diaphragm Typically: 4-6 breaths per minute 2. Progressive Muscle Relaxation (PMR) Tensing and relaxing different muscle groups Increases body awareness and reduces physical tension 3. Autogenic Training Uses visualizations and self-suggestions to induce relaxation (e.g., "My arms feel heavy and warm") Enhances self-regulation and calmness 4. Mindfulness Meditation Focuses on present-moment awareness Helps reduce intrusive thoughts, improve attention and emotional regulation

Relaxation trainingWhole body vibration

Eligibility Criteria

Age14 Years - 16 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly individuals who self-identify as female are eligible to participate. This includes all participants assigned female at birth who currently identify as female. The study focuses on Female Athlete Triad Syndrome, which specifically affects female physiology and hormonal profiles.
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Low energy availability (with or without disordered eating)
  • Menstrual dysfunction (oligomenorrhea)
  • Low bone mineral density or a history of stress fractures

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mti

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Relaxation Therapy

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

shaimaa MH elmarakby

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The outcome assessor will be blinded to group allocation to reduce measurement bias. Participants and intervention providers will not be blinded due to the nature of the exercise interventions.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned into three groups following a parallel design: Group A: Combined WBV and relaxation training Group B: relaxation training only All interventions will be conducted under physiotherapist supervision for 8 weeks. Pre- and post-assessments will be performed to evaluate changes in bone mineral density, menstrual hormonal regulation, and energy psychological state. This model allows for a clear comparison of the effects of WBV, relaxation techniques, and their combination on adolescent female athletes with Triad Syndrome.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of physical therapy for women health faculty of physical therapy MTI,UNI

Study Record Dates

First Submitted

May 1, 2026

First Posted

May 14, 2026

Study Start

November 2, 2025

Primary Completion

January 2, 2026

Study Completion

May 22, 2026

Last Updated

May 14, 2026

Record last verified: 2026-05

Locations