Effect of PEFLOW on PFM Function Recovery of Postpartum Women
6 de julio de 2022 actualizado por: Sun Xiuli, Peking University People's Hospital
Effect of Pelvic Floor Workout on Pelvic Floor Muscle Function Recovery of Postpartum Women
The purpose of this study is to explore the correlation between women's pelvic floor function with their overall state of bodily functions, including body composition, physical activity levels, trunk muscle endurance, body posture, vaginal and gut microbes.
The main intervention of this study is a set of global training which Includes the strength, endurance, flexibility, stability and flexibility training on the diaphragm, abdominal, lower back, as well as pelvic floor muscles, on the basis Kegel training.
The primary destination of global training is to shorten the cycle of postpartum pelvic floor functional recovery, improve the effect of maternal training, and convenient in clinical promotion.
Descripción general del estudio
Estado
Estado
Reclutamiento
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
Training for 2 times a week, for 12 weeks leading by a specific physiotherapist.The training intensity was evaluated by RPE self-induced fatigue scale.
Tipo de estudio
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
Inscripción
260
Fase
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
Estudio Contacto
- Nombre: Xiuli Sun, PHD
- Número de teléfono: 010-88324354
- Correo electrónico: sunxiuli03351@126.com
Ubicaciones de estudio
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Beijing
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Beijing, Beijing, Porcelana, 100044
- Reclutamiento
- The Peking University People's Hospital
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Contacto:
- Hongmei ZHU, doctor
- Número de teléfono: 010-88324354
- Correo electrónico: 1209304228@qq.com
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 50 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
Inclusion Criteria:
- Newly born women within 42 days to 3 months after delivery, after the end of puerperium, initial postpartum review and pelvic floor professional outpatient screening, found that pelvic floor muscle strength decreased (Oxford Oxford muscle strength ≤ grade 3);
- Healthy before pregnancy without pregnancy complications;
- Convenient transportation, familiar with the Internet;
- Be in good condition and be able to complete the exercise program;
- Complete clinical baseline data;
- Agreed to conduct the study and signed the informed consent.
Exclusion Criteria:
- Patients with stage Ⅲ and Ⅳ pelvic organ prolapse;
- Severe urinary incontinence;
- lochia, vaginal bleeding and pregnancy;
- Serious medical diseases, such as cardiac dysfunction who wear pacemakers, neurological diseases, cognitive impairment and other pathological conditions;
- Cannot complete the intervention program;
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
2
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Comparador activo: Routine education group
Routine education, including postpartum lifestyle, Kegel exercise and Knack method.
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Behavior guidance on pelvic floor muscle function training , including Knack method education , and Kegel exercise and other pelvic floor muscle training methods were taught to postpartum women.
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Experimental: Global training group
Global training was added on the basis of routine education.
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Behavior guidance on pelvic floor muscle function training , including Knack method education , and Kegel exercise and other pelvic floor muscle training methods were taught to postpartum women.
Global training was added on the basis of control group.
The 30min-training plan is divided into 9 sections, of which, groups 1 to 8, each group takes about 3 minutes, the ninth group is cool down section, including stretching for 5 minutes and foam axis stretching for 1 minute.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from Baseline pelvic floor muscle strength at 6 months or after 12 weeks training
Periodo de tiempo: Baseline; After 12 week training or 6th month postpartum
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The participants were instructed to contract the pelvic floor muscle correctly and allowed for one practice.
Three times of maximum contraction holding for five seconds with an interval resting of five seconds were performed, and the maximum value among three was recorded as the muscle strength of maximal voluntary contraction.
The result was recorded using the modified Oxford Grading scale, ranging from 0 to 5, which 0 represents no discernible pelvic floor muscle contraction and 5 represents a strong pelvic floor muscle contracion.
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Baseline; After 12 week training or 6th month postpartum
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Change from Baseline pelvic floor electrophysiology at 6 months or after 12 weeks training
Periodo de tiempo: Baseline; After 12 week training or 6th month postpartum
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We use Urostym to measure pelvic floor muscle strength which can identity the strength between Type I muscle fibers and Type II muscle fibers.
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Baseline; After 12 week training or 6th month postpartum
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Change from Baseline pelvic floor muscle strength at 1 year postpartum
Periodo de tiempo: Baseline; 1 year postpartum
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The participants were instructed to contract the pelvic floor muscle correctly and allowed for one practice.
Three times of maximum contraction holding for five seconds with an interval resting of five seconds were performed, and the maximum value among three was recorded as the muscle strength of maximal voluntary contraction.
The result was recorded using the modified Oxford Grading scale, ranging from 0 to 5, which 0 represents no discernible pelvic floor muscle contraction and 5 represents a strong pelvic floor muscle contracion.
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Baseline; 1 year postpartum
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Change from Baseline pelvic floor electrophysiology at 1 year postpartum
Periodo de tiempo: Baseline; 1 year postpartum
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We use Urostym to measure pelvic floor muscle strength which can identity the strength between Type I muscle fibers and Type II muscle fibers.
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Baseline; 1 year postpartum
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The occurrence of SUI
Periodo de tiempo: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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SUI is defined by SUI symptoms or a positive result of the stress test.
Before the stress test, participants are suggested to keep fully bladder.
Positive result of the stress test is defined as involuntarily urinary leakage when asked to cough in the lithotomy position.
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Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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Change from Pelvic floor ultrasound indicators
Periodo de tiempo: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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LAM thickness, diameter of the levator hiatus and levator hiatus area
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Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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Change from Pelvic Organ Prolapse Quantitation
Periodo de tiempo: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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Pelvic Organ Prolapse Quantitation is measured by callipers
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Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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Change from Physical activity levels
Periodo de tiempo: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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We use International Physical Activity Questionnaire score to measure the overall physical activity level during postpartum period.
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Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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Change from pelvic sagittal rotation degree
Periodo de tiempo: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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The quantitative measurement of pelvic sagittal rotation degree on X-ray was analyzed which includes the pelvic tilt angle , the sacral slope angle, the difference of sacral slope and pelvic tilt, the ratio of the pelvic tilt angle to the sacral slope angle, the ratio of the pelvic tilt angle to the pelvic incidence angle and sacral-femoral distance.
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Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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Change from body composition
Periodo de tiempo: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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Body composition analysis is measured which mainly includes Body Mass Index（BMI）based on height and weight in kg/m^2.
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Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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Change from body strength
Periodo de tiempo: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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Hand grip strength and trunk endurance are measured to describe body strength.
Hand grip strength was measured by JAMAR Plus+ grip gauge.
The measurement accuracy is 0.1kg.
The participants should not have visible hand defects.
The grip gauge should be adjusted before measurement.
When the paticipants holds the grip gauge, the second knuckle of the index finger should be at 90 degrees.
At the same time, mark the best position of each hand on the grip meter.
Before measurement, the participants should remove wrist jewelry to avoid injury.
And the left and right hand are measured alternately for 3 times.
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Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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Change from Pelvic Floor Distress Inventory（PFDI-20）Questionnaire Score
Periodo de tiempo: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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The Pelvic Floor Distress Inventory Questionnaire-20 (PFDI-20) is the short-form version of the Pelvic Floor Distress Inventory (PFDI).Since it is comprised of the UDI-6, POPDI-6, and the CRADI-8, the PFDI-20 includes 20 questions.The scale scores are found individually by calculating the mean value of their corresponding questions and then multiplying by 25 to obtain a value that ranges from 0 to 100.The sum of the 3 scales are added together to get the PFDI-20 summary score, which ranges from 0 to 300.
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Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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Change from PFIQ-7 Questionnaire Score
Periodo de tiempo: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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The Pelvic Floor Impact Questionnaire-7 (PFIQ-7) is a shortened, less comprehensive version of the Pelvic Floor Impact Questionnaire (PFIQ).To get scale scores, the mean of each of the 3 scales is individually calculated, which ranges from 0-3, this number is then multiplied by 100 and then divided by 3.The scale scores are then added together to get the total PFIQ-7 score, which ranges from 0-300.
A lower score means there is a lesser effect on quality of life.
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Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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Change from FSFI-6 Questionnaire Score
Periodo de tiempo: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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The 6-item Female Sexual Function Index (FSFI) is a short form of the original 19-item FSFI that measures sexual function in women.It comprises six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain.
Desire and satisfaction items are rated on a 5-point Likert scale, ranging from 1 to 5, and the other items are rated on a 6-point Likert scale, ranging from 0 to 5. Total scores range from 2 to 30, with lower scores indicating worse sexual functioning.
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Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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Change from the Pittsburgh Sleep Quality Index (PSQI) Score
Periodo de tiempo: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval.
Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
The sum of scores for these seven components yields one global score.
The 18 items consist of 7 components, and each component is scored according to the grade of 0 ~ 3. The cumulative score of each component is the total score of PSQI, and the total score range is 0~2l.
The higher the score, the worse the sleep quality.
It takes 5 to 10 minutes for the participants to complete the question.
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Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
2 de noviembre de 2021
Finalización primaria (Anticipado)
Finalización primaria
30 de junio de 2023
Finalización del estudio (Anticipado)
Finalización del estudio
30 de junio de 2023
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
1 de diciembre de 2021
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
29 de enero de 2022
Publicado por primera vez (Actual)
Publicado por primera vez
1 de febrero de 2022
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
11 de julio de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
6 de julio de 2022
Última verificación
Última verificación
1 de julio de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- PKUPH6
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Sí
Descripción del plan IPD
(1)Date of disclosure of raw data: December 2023.
Data content: original recorded data and research proposals; (2) Ways or means of sharing IPDs, contact the researchers.
Marco de tiempo para compartir IPD
2 years
Criterios de acceso compartido de IPD
contact the researchers
Tipo de información de apoyo para compartir IPD
- Protocolo de estudio
- Informe de estudio clínico (CSR)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .