NCT06683989

Brief Summary

The goal of this interventional study is to investigate how the gait parameters, pain, and posture of women who perform Pilates exercises during pregnancy are affected. This research targets pregnant women without any medical or obstetric complications who are experiencing physiological changes associated with pregnancy. The main questions it aims to answer are: Do Pilates exercises influence gait parameters in pregnant women? Does participation in Pilates improve pain and other functional parameters during pregnancy? Participants will: Undergo assessments of gait and related parameters. Participate in a Pilates exercise program tailored to their trimester. Provide feedback on pain and overall physical wellness during the study period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at below P25 for not_applicable pregnancy

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable pregnancy

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

First Submitted

Initial submission to the registry

November 9, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 12, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

November 15, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
Last Updated

February 19, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

November 9, 2024

Last Update Submit

February 18, 2025

Conditions

Keywords

pregnancypilates traininggait analysisposturepain

Outcome Measures

Primary Outcomes (1)

  • Gait Analysis

    Gait parameters will be assessed via the G-Walk. The G-Walk is a device that is worn on the waist via an elastic belt. The G-Walk is built with a triaxial accelerometer 16 bit/axes with multiple sensitivity, a triaxial magnetometer 13 bit and a triaxial gyroscope 16 bit/axes with multiple sensitivity. This hardware is capable of acquiring and transmitting data to a computer through a Bluetooth connection and at the end of each analysis an automatic report containing the gait assessment results is ready to be analyzed.

    5 minutes

Secondary Outcomes (2)

  • Posture

    10 minutes

  • Pain Level

    1 minutes

Study Arms (2)

Pilates group

EXPERIMENTAL

The Pilates exercise program will be conducted for eight weeks, two days per week.

Other: Pilates training

Control group

EXPERIMENTAL

Regular prenatal care for participants in the CG included standard nursing and medical treatments. Ergonomics information was provided to participants. No exercise regimen was prescribed.

Other: Prenatal care

Interventions

One hour of Pilates training was conducted for eight weeks, two days a week. Every training session was carried out by a certified and experienced physiotherapist from the Australian Institute of Pilates and Physiotherapy. The one-hour session was structured as a warm-up, a cool-down, and Pilates exercises.

Pilates group

Regular prenatal care for participants in the CG included standard nursing and medical treatments.

Control group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Primiparous and singleton pregnancy was defined as being between 20 and 35
  • Being at least in the 16th week of pregnancy

You may not qualify if:

  • Multiple pregnancies
  • Heart and lung problems
  • All situations in which exercise is contraindicated during pregnancy
  • Participation in different activity programs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Medipol University

Ankara, Altindag, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Exercise Movement TechniquesPrenatal Care

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeuticsPatient CareMaternal Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Halil Ibrahim Bulguroglu

    Ankara Medipol University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Both the statistical analyst and the evaluator were blind to the group assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Our randomized controlled trial divided the participants into a Pilates group (PG) and a control group (CG). Pilates exercises were applied to PG, while CG was given a prenatal care program.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sub-Investigator

Study Record Dates

First Submitted

November 9, 2024

First Posted

November 12, 2024

Study Start

November 15, 2024

Primary Completion

January 15, 2025

Study Completion

January 15, 2025

Last Updated

February 19, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations