Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Pilates and the Pelvic Floor: A Quasi-experimental Study

15. juni 2020 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

72

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Spanien
    • Huelva
      • Lepe, Huelva, Spanien, 21440
        • Carmen Feria Ramírez

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 50 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: 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.
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in the presence of pelvic floor injuries during childbirth after a Pilates Method program
Tidsramme: Between the eighth and tenth day after birth
Decrease in the number of episiotomies and perineal tears
Between the eighth and tenth day after birth

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Huelva

Efterforskere

  • Ledende efterforsker: Carmen Feria-Ramírez, CNM, University of Huelva

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

5. november 2018

Primær færdiggørelse (Faktiske)

31. juli 2019

Studieafslutning (Faktiske)

27. december 2019

Datoer for studieregistrering

Først indsendt

10. juni 2020

Først indsendt, der opfyldte QC-kriterier

10. juni 2020

Først opslået (Faktiske)

16. juni 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juni 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juni 2020

Sidst verificeret

1. juni 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CFMP14

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

The data will be available after the end of the study until one year the article publication.

IPD-delingsadgangskriterier

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.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Graviditet

  • King's College Hospital NHS Trust
    European Association for the Study of the Liver
    Rekruttering
    Leversygdom under graviditet
    Cirrhose, lever | HELLP syndrom | Intrahepatisk kolestase af graviditet | Graviditetssygdom | AFLP - Acute Fatty Lever of Pregnancy
    Det Forenede Kongerige

Kliniske forsøg med PILATES METHOD

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Moldova

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner