Pilates and the Pelvic Floor: A Quasi-experimental Study
15 de junho de 2020 atualizado por: Mª Carmen Feria Ramírez, University of Huelva
The Effects of the Pilates Method on Pelvic Floor Injuries During Pregnancy and Childbirth: A Quasi-experimental Study
In this paper, it is postulates that in pregnant women, the practice of PM led by a qualified professional for a period of four weeks can reduce the incidence of pelvic floor dysfunction (PFD) by decreasing the number of birth injuries.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Descrição detalhada
It is postulated that in pregnang women, the practice of PM can reduce the severity of birth injuries.
Our main objective was to determine the effectiveness of a PM program to reduce the incidence and degree of intrapartum perineal injuries as a way to reduce the incidence of female PFD.
Secondary objectives were:
Assess the role of a MP program on the systolic and diastolic blood pressure. Determine the effect of a MP program on body weight (BMI).
It is a parallel group clinical trial with an allocation ratio of 1:2.
All pregnant women will be informed about the nature of the clinical trial. There will be no differences in the pregnant´s follow-up because it will be performed by two same Pilates monitor with the same formation.
Once the pregnant women is assigned to an arm of the study, those assigned to the intervention group will be sent to the Pilates monitor to explain and initiate the exercise of MP program while the control group will be informed to maintain their usual monitoring of pregnancy.
In the initial visit, the type of physical activity will be evaluated by filling in the international physical activity questionnaire (IPAQ).
Tipo de estudo
Intervencional
Inscrição (Real)
72
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.
Locais de estudo
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Huelva
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Lepe, Huelva, Espanha, 21440
- Carmen Feria Ramírez
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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
Sim
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
Inclusion Criteria:
- To go to the Maternal Education program.
- Give your written consent to participate in the study.
- Singleton pregnancy.
- Low-risk pregnancy.
- No contraindication to physical exercise.
- Age equals or more than 18 years old.
Excusion Criteria:
- Pregnant women with poor pregnancy control.
- Difficulty in speaking or understanding Spanish.
- Required a C-section during delivery.
- Refusal to participate in the study.
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: Prevenção
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: PILATES METHOD
It was intended the Pilates program were low supervision and easily realizable by all patients, which implied flexibility in the schedule. In this sense the sessions of Pilates was adjusted to these assumptions and the Pilates monitor offered several schedules on diferent days of the week. The pregnant women assigned to the intervention group were supervised by the midwifery of reference and trained by a Pilates monitor who explained the training program. The women received eight sessions of Pilates, given with a frequency of two classes per week and one hour of duration during a period of four weeks. The exercises for each session were determined beforehand. In addition, the participants maintained the usual monitoring of pregnancy valued by the reference average, attending the sessions of the maternal education program of their health center. The therapeutic control were carried out by telephone call and clinical history review between the eighth and tenth day postpartum. |
It is intended that the Pilates program have a duration of four weeks and its realization does not suppose an excessive consumption of resources. Therefore, it must have a series of characteristics: low supervision and easily realizable by all patients, which implies flexibility in the schedule. In this sense the sessions of Pilates is adjusted to these assumptions and the Pilates monitor offers several schedules on diferent days of week. The pregnant women assigned to the intervention group will be supervised by the midwifery of reference and trained by a Pilates monitor who will explain the training program and resolve the doubts raised by the women. The therapeutic control will be carried out by telephone call and clinical history review between the eighth and tenth day. |
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Sem intervenção: MATERNAL EDUCATION
The control group maintained the usual monitoring of pregnancy valued by the reference average, attending the sessions of the maternal education program of their health center. Therapeutic control was carried out by phone call and review of the clinical history between the eighth and tenth day postpartum. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Changes in the presence of pelvic floor injuries during childbirth after a Pilates Method program
Prazo: Between the eighth and tenth day after birth
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Decrease in the number of episiotomies and perineal tears
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Between the eighth and tenth day after birth
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Carmen Feria-Ramírez, CNM, University of Huelva
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
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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)
5 de novembro de 2018
Conclusão Primária (Real)
31 de julho de 2019
Conclusão do estudo (Real)
27 de dezembro de 2019
Datas de inscrição no estudo
Enviado pela primeira vez
10 de junho de 2020
Enviado pela primeira vez que atendeu aos critérios de CQ
10 de junho de 2020
Primeira postagem (Real)
16 de junho de 2020
Atualizações de registro de estudo
Última Atualização Postada (Real)
17 de junho de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
15 de junho de 2020
Última verificação
1 de junho de 2020
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CFMP14
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
The individual data will be available after deidenttification (text, tables, figures and appendices) to those researchers who provide a methodologically sound proposal and for meta-analysis.
Prazo de Compartilhamento de IPD
The data will be available after the end of the study until one year the article publication.
Critérios de acesso de compartilhamento IPD
To obtain the data, a proposal must be sent to Carmen.feria@denf.uhu.es.
To gain access, data requestors will need to sign a data access agreement.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em PILATES METHOD
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Istanbul UniversityConcluídoDelírio pós-operatórioPeru
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Centre Cardiologique du NordAinda não está recrutandoDelírio pós-operatório | Profundidade AnestésicaFrança