Menstrual Cycle AbnormalWBV for triadNCT07587346
The Impact of Whole-Body Vibration and Relaxation Techniques on Adolescent Athlete Girls With Triad Syndrome"
A study testing whole body vibration device and relaxation training in people with Menstrual Cycle Abnormal, run by MTI University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 16 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Cycle Abnormal
- What is being tested?
- whole body vibration device and relaxation training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Nov 2025to 22 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 16 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Low energy availability (with or without disordered eating)
- Menstrual dysfunction (oligomenorrhea)
- Low bone mineral density or a history of stress fractures
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Mti
Cairo
shaimaa MH elmarakby, 01008585299, shaimaa.mohamed@pt.mti.edu.eg
About this study
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.
Read the detailed description
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.
- Conditions
- Menstrual Cycle Abnormal
- Being tested
- whole body vibration device, relaxation training
- Keywords
- Athelte traid , whole body vibration , relaxation technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole body vibration deviceDevice
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.
relaxation trainingOther
for both groups (A\&B) will receive relaxation Techniques Training
The program may include:
- Diaphragmatic (Deep) Breathing Focus on slow, controlled breathing from the diaphragm Typically: 4-6 breaths per minute
- Progressive Muscle Relaxation (PMR) Tensing and relaxing different muscle groups Increases body awareness and reduces physical tension
- Autogenic Training Uses visualizations and self-suggestions to induce relaxation (e.g., "My arms feel heavy and warm") Enhances self-regulation and calmness
- Mindfulness Meditation Focuses on present-moment awareness Helps reduce intrusive thoughts, improve attention and emotional regulation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: whole body vibration device; Other: 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. Receives: Other: relaxation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 2 months
Secondary outcomes (1)
psychological well-being
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start2 Nov 2025
- Primary completion2 Jan 2026
- Study completion22 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual Cycle AbnormalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MTI University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, shaimaa Mohamed hamed, MTI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07587346
- Sponsor's protocol ID
- REC/2111/MTI.PT/2511401
- Acronym
- WBV for triad
- Status last verified
- May 2026
- First submitted
- 1 May 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Whole-Body Vibration and Relaxation Techniques on Adolescent Athlete Girls With Triad Syndrome"
- ClinicalTrials.gov ID
- NCT07587346
- Acronym / sponsor ID
- WBV for triad / REC/2111/MTI.PT/2511401
- Conditions
- Menstrual Cycle Abnormal
- Keywords
- Athelte traid , whole body vibration , relaxation technique
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- MTI UniversityUniversity, hospital or other
- Study start
- 2 Nov 2025 (actual)
- Primary completion
- 2 Jan 2026 (actual)
- Study completion
- 22 May 2026 (estimated)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Whole body vibration | Experimental | Device: whole body vibration device, Other: relaxation traininggroup 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. |
| Relaxation training | Experimental | Other: relaxation traininggroup 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. |
Who may qualify
- Ages
- 14 to 16 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Low energy availability (with or without disordered eating)
- Menstrual dysfunction (oligomenorrhea)
- Low bone mineral density or a history of stress fractures
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| whole body vibration deviceParticipants 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. | Device | Whole body vibration |
| relaxation trainingfor 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 | Other | Relaxation training, Whole body vibration |
Primary outcome
hormonal regularity
Time frame: 2 months
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.
bone mineral density
Time frame: 2 months
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).
1 secondary outcome
psychological well-being
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whole body vibration device and relaxation training in people with Menstrual Cycle Abnormal, run by MTI University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact shaimaa MH elmarakby (01008585299, shaimaa.mohamed@pt.mti.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hormonal regularity (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.