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Clinical Pilates and Prenatal Education on Perinatal Depressive Symptoms (CPE-PE)

10. juni 2026 opdateret af: Mustafa Alperen Aksan, Gaziosmanpasa Research and Education Hospital

Combined Clinical Pilates Exercise and Prenatal Education and Perinatal Depressive Symptoms, Low Back Pain and Obstetric Outcomes: A Prospective Non-Randomized Controlled Study

This study evaluated whether a combined program of supervised Clinical Pilates Exercise and structured Prenatal Education, added to routine antenatal care, reduces perinatal depressive symptoms compared with routine antenatal care alone in nulliparous pregnant women. Secondary aims were to assess effects on pregnancy-related low back pain, labor pain, and obstetric outcomes. Allocation to the two groups was based on participants' availability to attend the program rather than on randomization; the study is therefore a non-randomized (quasi-experimental) controlled study.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This was a prospective, non-randomized, controlled (quasi-experimental) study conducted at a single tertiary women's health center between January 2021 and June 2022. Eighty-five nulliparous women with singleton pregnancies between 16 and 28 weeks of gestation, aged 18-35 years and with a pre-pregnancy body mass index below 30 kg/m2, were enrolled.

Participants were allocated to two parallel groups according to their availability to attend the intervention program. Women who could commit to the scheduled sessions were assigned to the intervention group (n=41) and received a supervised Clinical Pilates Exercise program (two 60-minute sessions per week until 32 weeks of gestation, moderate intensity, Borg 12-14, designed per ACOG recommendations) combined with a structured Prenatal Education program (four weekly sessions). After 32 weeks, exercises were continued at home with modifications. Women unable to attend due to scheduling constraints formed the control group (n=44) and received routine antenatal care only.

Depressive symptoms were assessed with the Edinburgh Postnatal Depression Scale (EPDS) at baseline (16-28 weeks), at 32 weeks of gestation, and at 6 months postpartum. Pregnancy-related low back pain was assessed with the Numeric Pain Rating Scale, labor pain with a Visual Analog Scale (vaginal deliveries), and obstetric outcomes (duration of labor, mode of delivery, gestational age at delivery, birth weight, Apgar scores) were recorded after delivery.

Because allocation was not randomized and significant baseline differences were observed between groups, baseline-adjusted analyses (mixed-effects models, ANCOVA) and propensity-score sensitivity analyses were used. Given the non-randomized design, findings are considered hypothesis-generating. The study was registered retrospectively.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

85

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Tyrkiet (Türkiye)
      • Ankara, Tyrkiet (Türkiye)
        • Etlik Zübeyde Hanım Women's Health Training and Research Hospital

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

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • Nulliparous
  • Singleton pregnancy
  • Gestational age 16-28 weeks at enrollment
  • Age 18-35 years
  • Pre-pregnancy body mass index < 30 kg/m2

Exclusion Criteria:

  • Multiple pregnancy
  • Systemic disease, including diabetes mellitus, hypertension, or cardiovascular disorders

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Clinical Pilates Exercise + Prenatal Education
Supervised Clinical Pilates Exercise (two 60-minute moderate-intensity sessions per week, Borg 12-14, until 32 weeks of gestation; home-based thereafter with modifications) plus a structured Prenatal Education program of four weekly sessions, in addition to routine antenatal care
Adfærdsmæssigt: Clinical Pilates Exercise
Supervised, moderate-intensity (Borg 12-14) clinical Pilates program emphasizing core stabilization, controlled breathing, and postural alignment; two 60-minute sessions per week until 32 weeks of ges
Adfærdsmæssigt: Prenatal Education

Structured prenatal education delivered in four weekly sessions covering pregnancy physiology, labor and birth preparation, coping strategies, and newborn/postpartum care, structured per ACOG recommendations.'

- Arm/Group: 'Clinical Pilates Exercise + Prenatal Education
Ingen indgriben: Routine Antenatal Care
Routine antenatal care only, including regular obstetric examinations, basic prenatal education, nutritional counseling, and management of common pregnancy-related complaints. No structured exercise or additional psychological support was provided.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Edinburgh Postnatal Depression Scale (EPDS) score
Tidsramme: Baseline (16-28 weeks of gestation), 32 weeks of gestation, and 6 months postpartum
Self-reported depressive symptoms measured with the 10-item EPDS (total score 0-30; higher scores indicate more depressive symptoms; >=13 indicates clinically relevant symptoms).
Baseline (16-28 weeks of gestation), 32 weeks of gestation, and 6 months postpartum
Low back pain
Tidsramme: Baseline and 32 weeks of gestation
Presence and severity of pregnancy-related low back pain measured with the Numeric Pain Rating Scale (0-10).
Baseline and 32 weeks of gestation

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Labor pain (VAS)
Tidsramme: During labor / delivery
Pain intensity during childbirth measured with a 10-cm Visual Analog Scale (0-10), in women with vaginal delivery.
During labor / delivery

Samarbejdspartnere og efterforskere

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

Sponsor

Gaziosmanpasa Research and Education Hospital

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)

1. januar 2021

Primær færdiggørelse (Faktiske)

10. juni 2022

Studieafslutning (Faktiske)

30. juni 2022

Datoer for studieregistrering

Først indsendt

10. juni 2026

Først indsendt, der opfyldte QC-kriterier

10. juni 2026

Først opslået (Faktiske)

15. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GOP-CPE-PE-2021
  • 2018/27 (Anden identifikator: Etlik Zubeyde Hanim Women's Health Training and Research Hospital Clinical Research Ethics Committee)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified participant data are available in the Zenodo repository.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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