Effect of PEFLOW on PFM Function Recovery of Postpartum Women
6 de julho de 2022 atualizado 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.
Visão geral do estudo
Status
Recrutamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Antecipado)
260
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Xiuli Sun, PHD
- Número de telefone: 010-88324354
- E-mail: sunxiuli03351@126.com
Locais de estudo
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Beijing
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Beijing, Beijing, China, 100044
- Recrutamento
- The Peking University People's Hospital
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Contato:
- Hongmei ZHU, doctor
- Número de telefone: 010-88324354
- E-mail: 1209304228@qq.com
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 50 anos (Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
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;
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from Baseline pelvic floor muscle strength at 6 months or after 12 weeks training
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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The occurrence of SUI
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
2 de novembro de 2021
Conclusão Primária (Antecipado)
30 de junho de 2023
Conclusão do estudo (Antecipado)
30 de junho de 2023
Datas de inscrição no estudo
Enviado pela primeira vez
1 de dezembro de 2021
Enviado pela primeira vez que atendeu aos critérios de CQ
29 de janeiro de 2022
Primeira postagem (Real)
1 de fevereiro de 2022
Atualizações de registro de estudo
Última Atualização Postada (Real)
11 de julho de 2022
Última atualização enviada que atendeu aos critérios de controle de qualidade
6 de julho de 2022
Última verificação
1 de julho de 2022
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- PKUPH6
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Sim
Descrição do plano 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.
Prazo de Compartilhamento de IPD
2 years
Critérios de acesso de compartilhamento IPD
contact the researchers
Tipo de informação de suporte de compartilhamento de IPD
- Protocolo de estudo
- Relatório de Estudo Clínico (CSR)
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