- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07806968
Effect of Postural Correction Exercises on Pelvic Floor Dysfunction in Postmenopausal Osteoporotic Women
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Osteoporosis is a progressive musculoskeletal disease that significantly affects postmenopausal women, leading not only to reduced bone density but also to altered spinal and pelvic alignment, which negatively impacts functional capacity and quality of life. These postural deviations are associated with changes in pelvic biomechanics and increased prevalence of pelvic floor muscle (PFM) dysfunction.
Pelvic floor dysfunction in postmenopausal women is a major health concern, manifesting as urinary incontinence, pelvic discomfort, and reduced core stability. Recent evidence suggests a strong relationship between pelvic tilt, lumbar lordosis, and pelvic floor muscle function, indicating that abnormal posture may compromise pelvic floor support and contribute to dysfunction and symptomatic severity. This highlights the biomechanical interdependence between posture and pelvic floor activity.
Emerging evidence suggests a potential association between osteoporosis and pelvic floor dysfunction (PFD). Studies have demonstrated that reduced bone strength and low bone mineral density are associated with a higher prevalence of pelvic floor symptoms among postmenopausal women.
Pelvic floor muscle training (PFMT) is widely recognized as a first-line conservative treatment for pelvic floor dysfunction (PFD) However, emerging evidence suggests that PFMT alone may not be sufficient to fully address symptoms in all individuals, especially when underlying biomechanical and postural factors are present. Recent studies have highlighted the importance of lumbopelvic alignment and postural control in optimizing pelvic floor muscle function, as alterations in spinal curvature and pelvic tilt can influence muscle activation and intra-abdominal pressure distribution.
Interventions that target postural correction may therefore play a crucial role in optimizing pelvic floor function. A clinical study demonstrated that posture correction therapy, including postural alignment and behavioral modifications, significantly influenced pelvic floor muscle activity as measured by electromyography in women suggesting that addressing postural deviations may enhance pelvic floor rehabilitation outcomes.
Furthermore, postural and stabilization exercises focusing on spinal alignment have been shown to improve pelvic floor muscle strength, core stability, urinary symptoms, and quality of life in women with functional pelvic disorders such as overactive bladder.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Mahitab M Yosri, PHD
- Numero di telefono: 01222606996
- Email: mahitab.yosri@pt.cu.edu.eg
Backup dei contatti dello studio
- Nome: Alaa M Ebrahim, Master
- Numero di telefono: 01090988989
- Email: Alaanegm95@icloud.com
Luoghi di studio
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Giza, Egitto
- Cairo University
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Contatto:
- Alaa M Ebrahim, Master
- Numero di telefono: 01090988989
- Email: Alaanegm95@icloud.com
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Postmenopausal women with ages between 55 and 65 years.
- Their body mass index will not exceed 35 Kg/m2.
- All women have mild to moderate pelvic floor muscle dysfunction.
- All women were diagnosed with osteoporosis confirmed by Dual-energy X-ray Absorptiometry (DEXA) (T-score ≤ -2.5).
Exclusion Criteria:
- Women will be excluded if they have one or more of the following:
- Previous pelvic or abdominal surgery affecting pelvic floor function.
- Severe pelvic organ prolapse (Grade III or IV).
- Neurological disorders affecting pelvic floor or lower limb function.
- Severe musculoskeletal disorders limiting exercise participation.
- Current participation in pelvic floor rehabilitation programs during the last 6 months.
- Severe cardiovascular or respiratory conditions contraindicating exercise.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore attivo: Estrogen replacement therapy and general advice group
The participants will receive estrogen replacement therapy and general advice for 3 months
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The participants will receive estrogen replacement therapy for 3 months to enhance postmenopausal symptoms and their quality of life
Postmenopausal women will be instructed to maintain a neutral spinal alignment during sitting, standing, and daily activities, avoid prolonged slouched sitting, and use supportive seating to encourage correct posture.
Light to moderate physical activity, such as daily walking, will be encouraged to reduce sedentary behavior and maintain overall physical function.
women will also receive guidance on healthy bowel and bladder habits, including avoiding straining during bowel movements and unnecessary frequent urination, as increased intra-abdominal pressure can worsen pelvic floor dysfunction.
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Sperimentale: Postural correction exercise program group
The participants will receive postural correction exercise program, in addition to estrogen replacement therapy and general advice for 3 months
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The participants will receive estrogen replacement therapy for 3 months to enhance postmenopausal symptoms and their quality of life
Postmenopausal women will be instructed to maintain a neutral spinal alignment during sitting, standing, and daily activities, avoid prolonged slouched sitting, and use supportive seating to encourage correct posture.
Light to moderate physical activity, such as daily walking, will be encouraged to reduce sedentary behavior and maintain overall physical function.
women will also receive guidance on healthy bowel and bladder habits, including avoiding straining during bowel movements and unnecessary frequent urination, as increased intra-abdominal pressure can worsen pelvic floor dysfunction.
The participants will follow a structured postural correction exercise program, 3 times per week for 12 weeks, each session lasting 45-60 minutes.
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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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Pelvic Floor Muscle Assessment
Lasso di tempo: 12 weeks
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Pelvic floor muscle function will be assessed using surface electromyographic (EMG) to measure muscle activation patterns.
For the measurement, women will be placed in a supine position with knees flexed.
A vaginal surface probe electrode will be gently inserted to record pelvic floor muscle (PFM) activity, and a reference electrode will be placed on a bony landmark such as the anterior superior iliac spine to reduce electrical noise.
Participants will be instructed to contract their pelvic floor muscles as if stopping urine flow, holding each contraction for 5 seconds, followed by 10 seconds of relaxation.
Each contraction will be repeated three times, and the highest root mean square RMS amplitude of the three contractions will be used for analysis.
EMG signals will be processed to calculate RMS amplitude and normalized to maximum voluntary contraction for inter-individual comparisons
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12 weeks
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Kyphotic angle
Lasso di tempo: 12 weeks
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Formetric System will be used to evaluate spinal alignment parameters including thoracic kyphosis before and after treatment The system is a non-invasive, radiation-free optical imaging technology that projects a light grid onto the back surface and captures the reflected pattern using a high-resolution digital camera.
Using surface topography, the software reconstructs a three-dimensional model of the back allowing precise calculation of spinal angles.
Thoracic kyphosis angle is measured as the angle between tangent lines at the upper and lower thoracic vertebrae.
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12 weeks
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Lumbar lordotic angle
Lasso di tempo: 12 weeks
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Formetric System will be used to evaluate spinal alignment parameters including lumbar lordosis before and after treatment The system is a non-invasive, radiation-free optical imaging technology that projects a light grid onto the back surface and captures the reflected pattern using a high-resolution digital camera.
Using surface topography, the software reconstructs a three-dimensional model of the back allowing precise calculation of spinal angles.
Lumbar lordosis angle as the angle between tangent lines at the upper lumbar and sacral vertebrae.
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12 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Menopause-specific quality of life questionnaire
Lasso di tempo: 12 Weeks
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The MENQOL is self-administered and consists of a total of 29 items in a Likert-scale format.
Each item assesses the impact of one of four domains of menopausal symptoms, as experienced over the last month: vasomotor (items 1-3), psychosocial (items 4-10), physical (items 11-26), and sexual (items 27-29).
Items pertaining to a specific symptom are rated as present or not present, and if present, how bothersome on a zero (not bothersome) to six (extremely bothersome) scale
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12 Weeks
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Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Hatem M Hasan, As.professor, National Research Center
- Cattedra di studio: Mohamed A Awad, Professor, Cairo University
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Primo Inserito (Effettivo)
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Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- P.T.REC/012/006597
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