Pilates and the Pelvic Floor: A Quasi-experimental Study
15 de junio de 2020 actualizado 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.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Actual)
72
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.
Ubicaciones de estudio
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Huelva
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Lepe, Huelva, España, 21440
- Carmen Feria Ramírez
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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
Edades elegibles para estudiar
18 años a 50 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Femenino
Descripción
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.
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: Prevención
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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. |
|
Sin intervención: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes in the presence of pelvic floor injuries during childbirth after a Pilates Method program
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Carmen Feria-Ramírez, CNM, University of Huelva
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.
Publicaciones Generales
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- Oblasser C, McCourt C, Hanzal E, Christie J. Vibrating vaginal balls to improve pelvic floor muscle performance in women after childbirth: a protocol for a randomised controlled feasibility trial. J Adv Nurs. 2016 Apr;72(4):900-14. doi: 10.1111/jan.12868. Epub 2015 Dec 28.
- Cruz-Ferreira A, Fernandes J, Laranjo L, Bernardo LM, Silva A. A systematic review of the effects of pilates method of exercise in healthy people. Arch Phys Med Rehabil. 2011 Dec;92(12):2071-81. doi: 10.1016/j.apmr.2011.06.018. Epub 2011 Oct 24.
- Neels H, Wyndaele JJ, Tjalma WA, De Wachter S, Wyndaele M, Vermandel A. Knowledge of the pelvic floor in nulliparous women. J Phys Ther Sci. 2016 May;28(5):1524-33. doi: 10.1589/jpts.28.1524. Epub 2016 May 31.
- Culligan PJ, Scherer J, Dyer K, Priestley JL, Guingon-White G, Delvecchio D, Vangeli M. A randomized clinical trial comparing pelvic floor muscle training to a Pilates exercise program for improving pelvic muscle strength. Int Urogynecol J. 2010 Apr;21(4):401-8. doi: 10.1007/s00192-009-1046-z. Epub 2010 Jan 22.
- Smith LA, Price N, Simonite V, Burns EE. Incidence of and risk factors for perineal trauma: a prospective observational study. BMC Pregnancy Childbirth. 2013 Mar 7;13:59. doi: 10.1186/1471-2393-13-59.
- Wells C, Kolt GS, Bialocerkowski A. Defining Pilates exercise: a systematic review. Complement Ther Med. 2012 Aug;20(4):253-62. doi: 10.1016/j.ctim.2012.02.005. Epub 2012 Mar 13.
- Dieb AS, Shoab AY, Nabil H, Gabr A, Abdallah AA, Shaban MM, Attia AH. Perineal massage and training reduce perineal trauma in pregnant women older than 35 years: a randomized controlled trial. Int Urogynecol J. 2020 Mar;31(3):613-619. doi: 10.1007/s00192-019-03937-6. Epub 2019 Apr 2.
- Hyakutake MT, Han V, Cundiff GW, Baerg L, Koenig NA, Lee T, Geoffrion R. Pelvic Floor Health Education: Can a Workshop Enhance Patient Counseling During Pregnancy? Female Pelvic Med Reconstr Surg. 2016 Sep-Oct;22(5):336-9. doi: 10.1097/SPV.0000000000000285.
- Almagiá E. Influencia del estado emocional en la salud física. Terapia psicológica. 2003; 21(1): 38.
- Aguiar M, Farley A, Hope L, Amin A, Shah P, Manaseki-Holland S. Birth-Related Perineal Trauma in Low- and Middle-Income Countries: A Systematic Review and Meta-analysis. Matern Child Health J. 2019 Aug;23(8):1048-1070. doi: 10.1007/s10995-019-02732-5.
- Graham ID, Carroli G, Davies C, Medves JM. Episiotomy rates around the world: an update. Birth. 2005 Sep;32(3):219-23. doi: 10.1111/j.0730-7659.2005.00373.x.
- Jansson MH, Nilsson K, Franzen K. Development and validation of a protocol for documentation of obstetric perineal lacerations. Int Urogynecol J. 2019 Dec;30(12):2069-2076. doi: 10.1007/s00192-019-03915-y. Epub 2019 Mar 19.
- Jiang H, Qian X, Carroli G, Garner P. Selective versus routine use of episiotomy for vaginal birth. Cochrane Database Syst Rev. 2017 Feb 8;2(2):CD000081. doi: 10.1002/14651858.CD000081.pub3.
- Latorre GFS, de Fraga R, Seleme MR, Mueller CV, Berghmans B. An ideal e-health system for pelvic floor muscle training adherence: Systematic review. Neurourol Urodyn. 2019 Jan;38(1):63-80. doi: 10.1002/nau.23835. Epub 2018 Oct 30.
- Mączka M, Sass A. Pilates and mobilization methods in therapy for low back pain among pregnant women. Journal of Exercise Science & Fitness. 2017; 7(8): 473-488.
- Boix-Vilella S, León-Zarceño E, Serrano-Rosa MA. Evidencias de la práctica Pilates sobre la salud mental de personas sanas. Rev Universidad y Salud. 2017; 19(2): 301-308.
- Bozkurt M, Yumru AE, Sahin L. Pelvic floor dysfunction, and effects of pregnancy and mode of delivery on pelvic floor. Taiwan J Obstet Gynecol. 2014 Dec;53(4):452-8. doi: 10.1016/j.tjog.2014.08.001.
- Davidson K, Jacoby S, Brown MS. Prenatal perineal massage: preventing lacerations during delivery. J Obstet Gynecol Neonatal Nurs. 2000 Sep-Oct;29(5):474-9. doi: 10.1111/j.1552-6909.2000.tb02768.x.
- Dias NT, Ferreira LR, Fernandes MG, Resende APM, Pereira-Baldon VS. A Pilates exercise program with pelvic floor muscle contraction: Is it effective for pregnant women? A randomized controlled trial. Neurourol Urodyn. 2018 Jan;37(1):379-384. doi: 10.1002/nau.23308. Epub 2017 May 23.
- D'Souza JC, Monga A, Tincello DG. Risk factors for perineal trauma in the primiparous population during non-operative vaginal delivery. Int Urogynecol J. 2020 Mar;31(3):621-625. doi: 10.1007/s00192-019-03944-7. Epub 2019 May 2.
- Escuriet R, Pueyo MJ, Perez-Botella M, Espada X, Salgado I, Gomez A, Biescas H, Espiga I, White J, Fernandez R, Fuste J, Ortun V. Cross-sectional study comparing public and private hospitals in Catalonia: is the practice of routine episiotomy changing? BMC Health Serv Res. 2015 Mar 11;15:95. doi: 10.1186/s12913-015-0753-z.
- Guzmán P, Díaz AM, Gómez D, Guzmán R, Guzmán A. Actuación del fisioterapeuta en el tratamiento integral de la embarazada. Nure Investigación. 2013; 2(63): 1-8.
- Howard D, Makhlouf M. Can pelvic floor dysfunction after vaginal birth be prevented? Int Urogynecol J. 2016 Dec;27(12):1811-1815. doi: 10.1007/s00192-016-3117-2. Epub 2016 Aug 15.
- Kyvernitakis I, Kohler C, Schmidt S, Misselwitz B, Grossmann J, Hadji P, Kalder M. Impact of maternal body mass index on the cesarean delivery rate in Germany from 1990 to 2012. J Perinat Med. 2015 Jul;43(4):449-54. doi: 10.1515/jpm-2014-0126.
- Leon-Larios F, Corrales-Gutierrez I, Casado-Mejia R, Suarez-Serrano C. Influence of a pelvic floor training programme to prevent perineal trauma: A quasi-randomised controlled trial. Midwifery. 2017 Jul;50:72-77. doi: 10.1016/j.midw.2017.03.015. Epub 2017 Mar 27.
- Llewellyn H, Konstantaki M, Johnson MI, Francis P. The Effect of a Pilates Exercise Programme on Perceived Functional Disability and Pain Associated with Non-Specific Chronic Low Back Pain. MOJ Yoga & Physical Therapy. 2017; 2(1): 00013.
- López M, Palacio M, del Pino M, Puig M, Bataller E, Espuña M. Protocolo: lesiones perineales de origen obstétrico. Diagnóstico, tratamiento y seguimiento. Servei de Medicina Maternofetal. Barcelona. Institut Clínic de Ginecologia, Obstetrícia i Neonatologia, Hospital Clínic de Barcelona. 2014.
- Navarro CL, Luján MI. Nuevos sistemas de comunicación del método Pilates en embarazo y puerperio. Revista Española de Comunicación en Salud. 2017; 8(1): 20-28.
- Oktaviani I. Pilates workouts can reduce pain in pregnant women. Complement Ther Clin Pract. 2018 May;31:349-351. doi: 10.1016/j.ctcp.2017.11.007. Epub 2017 Nov 16.
- Organización Mundial de la Salud.Cuidados en el parto normal: una guía práctica. Revista Hospital Materno Infantil Ramón Sardá. 1999; 18: 78-80.
- Pierce H, Perry L, Gallagher R, Chiarelli P. Pelvic floor health: a concept analysis. J Adv Nurs. 2015 May;71(5):991-1004. doi: 10.1111/jan.12628. Epub 2015 Feb 10.
- Rodriguez-Diaz L, Ruiz-Frutos C, Vazquez-Lara JM, Ramirez-Rodrigo J, Villaverde-Gutierrez C, Torres-Luque G. Effectiveness of a physical activity programme based on the Pilates method in pregnancy and labour. Enferm Clin. 2017 Sep-Oct;27(5):271-277. doi: 10.1016/j.enfcli.2017.05.008. Epub 2017 Jul 6. English, Spanish.
- Sarpkaya D.S., Yalvaç M. & Vural G. The effect of pregnancy Pilates-assisted childbirth preparation training on childbirth fear and neonatal outcomes: a quasi-experimental/quantitative research. Quality & Quantitive. 2018; 1-13.
- Shaban MM, Bassiouny YA, Elzahaby IM, Hassan AA. Body mass index and labour outcome in Egyptian women. J Obstet Gynaecol. 2014 Apr;34(3):248-50. doi: 10.3109/01443615.2013.844113. Epub 2013 Dec 2.
- Zimmo K, Laine K, Vikanes A, Fosse E, Zimmo M, Ali H, Thakar R, Sultan AH, Hassan S. Diagnosis and repair of perineal injuries: knowledge before and after expert training-a multicentre observational study among Palestinian physicians and midwives. BMJ Open. 2017 Apr 7;7(4):e014183. doi: 10.1136/bmjopen-2016-014183.
- Rise E, Bo K, Nystad W. Is there any association between abdominal strength training before and during pregnancy and delivery outcome? The Norwegian Mother and Child Cohort Study. Braz J Phys Ther. 2019 Mar-Apr;23(2):108-115. doi: 10.1016/j.bjpt.2018.06.006. Epub 2018 Jul 6.
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- Verghese TS, Champaneria R, Kapoor DS, Latthe PM. Obstetric anal sphincter injuries after episiotomy: systematic review and meta-analysis. Int Urogynecol J. 2016 Oct;27(10):1459-67. doi: 10.1007/s00192-016-2956-1. Epub 2016 Feb 19.
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- Feria-Ramirez C, Gonzalez-Sanz JD, Molina-Luque R, Molina-Recio G. The Effects of the Pilates Method on Pelvic Floor Injuries during Pregnancy and Childbirth: A Quasi-Experimental Study. Int J Environ Res Public Health. 2021 Jun 30;18(13):6995. doi: 10.3390/ijerph18136995.
Enlaces Útiles
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)
5 de noviembre de 2018
Finalización primaria (Actual)
31 de julio de 2019
Finalización del estudio (Actual)
27 de diciembre de 2019
Fechas de registro del estudio
Enviado por primera vez
10 de junio de 2020
Primero enviado que cumplió con los criterios de control de calidad
10 de junio de 2020
Publicado por primera vez (Actual)
16 de junio de 2020
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de junio de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
15 de junio de 2020
Última verificación
1 de junio de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CFMP14
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan 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.
Marco de tiempo para compartir IPD
The data will be available after the end of the study until one year the article publication.
Criterios de acceso compartido de 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 información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
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
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. .
Ensayos clínicos sobre PILATES METHOD
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Aydin Adnan Menderes UniversityAún no reclutando
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Aydin Adnan Menderes UniversityAún no reclutandoEducación | Estudiantes de EnfermeríaPavo
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Centre Cardiologique du NordAún no reclutandoDelirio postoperatorio | Profundidad anestésicaFrancia