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Pilates and the Pelvic Floor: A Quasi-experimental Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04431102
Recruitment Status : Completed
First Posted : June 16, 2020
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
Mª Carmen Feria Ramírez, University of Huelva

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pregnancy Perineum; Injury Pilates Method Episiotomy Wound Other: PILATES METHOD Not Applicable

Detailed Description:

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects of the Pilates Method on Pelvic Floor Injuries During Pregnancy and Childbirth: A Quasi-experimental Study
Actual Study Start Date : November 5, 2018
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : December 27, 2019

Arm Intervention/treatment
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.

Other: 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.


No Intervention: 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.




Primary Outcome Measures :
  1. Changes in the presence of pelvic floor injuries during childbirth after a Pilates Method program [ Time Frame: Between the eighth and tenth day after birth ]
    Decrease in the number of episiotomies and perineal tears



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04431102


Locations
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Spain
Carmen Feria Ramírez
Lepe, Huelva, Spain, 21440
Sponsors and Collaborators
University of Huelva
Investigators
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Principal Investigator: Carmen Feria-Ramírez, CNM University of Huelva
  Study Documents (Full-Text)

Documents provided by Mª Carmen Feria Ramírez, University of Huelva:
Informed Consent Form  [PDF] October 10, 2018

Additional Information:
Publications:
Almagiá E. Influencia del estado emocional en la salud física. Terapia psicológica. 2003; 21(1): 38.
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.
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.
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.
Organización Mundial de la Salud.Cuidados en el parto normal: una guía práctica. Revista Hospital Materno Infantil Ramón Sardá. 1999; 18: 78-80.
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mª Carmen Feria Ramírez, Principal investigator, University of Huelva
ClinicalTrials.gov Identifier: NCT04431102    
Other Study ID Numbers: CFMP14
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: The data will be available after the end of the study until one year the article publication.
Access Criteria: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mª Carmen Feria Ramírez, University of Huelva:
Nursing
Midwifery
Nurse
Pilates Method
Pelvic floor
Injuries
Episiotomy
Pregnancy
Additional relevant MeSH terms:
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Wounds and Injuries