Pilates and the Pelvic Floor: A Quasi-experimental Study

NCT ID: NCT04431102

Last Updated: 2020-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-05

Study Completion Date

2019-12-27

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Pregnancy Perineum; Injury Pilates Method Episiotomy Wound

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

The professionals who assessed the progress of labor in the delivery room and completed the medical history did not know whether the woman belonged to the intervention or the control group.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

PILATES METHOD

Intervention Type OTHER

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PILATES METHOD

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Huelva

OTHER

Sponsor Role lead

Responsible Party

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Mª Carmen Feria Ramírez

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carmen Feria-Ramírez, CNM

Role: PRINCIPAL_INVESTIGATOR

University of Huelva

Locations

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Carmen Feria Ramírez

Lepe, Huelva, Spain

Site Status

Countries

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Spain

References

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Almagiá E. Influencia del estado emocional en la salud física. Terapia psicológica. 2003; 21(1): 38.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 30915627 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30941442 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16128977 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30888454 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28176333 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30375056 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 25510682 (View on PubMed)

Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

Reference Type BACKGROUND
PMID: 12900694 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22030232 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20094704 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11012126 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28543751 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31049642 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25889079 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 27525694 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27171319 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24914711 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28391147 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 27313364 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26708615 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29173892 (View on PubMed)

Organización Mundial de la Salud.Cuidados en el parto normal: una guía práctica. Revista Hospital Materno Infantil Ramón Sardá. 1999; 18: 78-80.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 25675895 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28689647 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 24294988 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23497085 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22579438 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28389490 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30017257 (View on PubMed)

Uccella S, Manzoni P, Marconi N, Toscani C, Biasoli S, Cianci S, Franchi M, Sorice P, Bertoli F, Zorzato PC, Gallina D, Ghezzi F, Serati M. Impact of Sport Activity and Physical Exercise on Obstetrical and Perineal Outcomes at Delivery: A Prospective Study. Am J Perinatol. 2019 Jul;36(S 02):S83-S90. doi: 10.1055/s-0039-1691816. Epub 2019 Jun 25.

Reference Type BACKGROUND
PMID: 31238366 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26894605 (View on PubMed)

Waddington H, Aloe AM, Becker BJ, Djimeu EW, Hombrados JG, Tugwell P, Wells G, Reeves B. Quasi-experimental study designs series-paper 6: risk of bias assessment. J Clin Epidemiol. 2017 Sep;89:43-52. doi: 10.1016/j.jclinepi.2017.02.015. Epub 2017 Mar 27.

Reference Type BACKGROUND
PMID: 28351693 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34208859 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

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Related Links

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Other Identifiers

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CFMP14

Identifier Type: -

Identifier Source: org_study_id

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