NCT07647809

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2022

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 15, 2026

Completed
Last Updated

June 15, 2026

Status Verified

June 1, 2026

Enrollment Period

1.4 years

First QC Date

June 10, 2026

Last Update Submit

June 10, 2026

Conditions

Keywords

clinical pilatesprenatal educationperinatal depressionEPDSantenatal exercise

Outcome Measures

Primary Outcomes (2)

  • Edinburgh Postnatal Depression Scale (EPDS) score

    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

    Presence and severity of pregnancy-related low back pain measured with the Numeric Pain Rating Scale (0-10).

    Baseline and 32 weeks of gestation

Secondary Outcomes (1)

  • Labor pain (VAS)

    During labor / delivery

Study Arms (2)

Clinical Pilates Exercise + Prenatal Education

EXPERIMENTAL

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

Behavioral: Clinical Pilates ExerciseBehavioral: Prenatal Education

Routine Antenatal Care

NO INTERVENTION

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.

Interventions

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

Clinical Pilates Exercise + 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

Clinical Pilates Exercise + Prenatal Education

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Etlik Zübeyde Hanım Women's Health Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depression, PostpartumLow Back PainLabor Pain

Interventions

Prenatal Education

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental DisordersBack PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Education as TopicHealth EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist / Op. Dr.

Study Record Dates

First Submitted

June 10, 2026

First Posted

June 15, 2026

Study Start

January 1, 2021

Primary Completion

June 10, 2022

Study Completion

June 30, 2022

Last Updated

June 15, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

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

More information

Locations