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

10 de junio de 2026 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

85

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

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

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

  • Adulto

Acepta Voluntarios Saludables

Descripción

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

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: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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
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

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

Sin intervención: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Edinburgh Postnatal Depression Scale (EPDS) score
Periodo de tiempo: 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
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Labor pain (VAS)
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

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)

1 de enero de 2021

Finalización primaria (Actual)

10 de junio de 2022

Finalización del estudio (Actual)

30 de junio de 2022

Fechas de registro del estudio

Enviado por primera vez

10 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

10 de junio de 2026

Publicado por primera vez (Actual)

15 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

10 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Descripción del plan IPD

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

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. .

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