- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07806968
Effect of Postural Correction Exercises on Pelvic Floor Dysfunction in Postmenopausal Osteoporotic Women
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Mahitab M Yosri, PHD
- 전화번호: 01222606996
- 이메일: mahitab.yosri@pt.cu.edu.eg
연구 연락처 백업
- 이름: Alaa M Ebrahim, Master
- 전화번호: 01090988989
- 이메일: Alaanegm95@icloud.com
연구 장소
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Giza, 이집트
- Cairo University
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연락하다:
- Alaa M Ebrahim, Master
- 전화번호: 01090988989
- 이메일: Alaanegm95@icloud.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Pelvic Floor Muscle Assessment
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Menopause-specific quality of life questionnaire
기간: 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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공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Hatem M Hasan, As.professor, National Research Center
- 연구 의자: Mohamed A Awad, Professor, Cairo University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- P.T.REC/012/006597
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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