NCT06684002

Brief Summary

The goal of this clinical trial is to investigate whether Pilates exercises can help manage musculoskeletal laxity in pregnant women. It will also examine the safety of Pilates exercises during pregnancy. The primary questions this trial aims to answer are: Does Pilates exercise reduce the level of laxity in pregnant women? What physical issues do participants experience while performing Pilates exercises during pregnancy? Participants will: Engage in Pilates exercises tailored for pregnancy, under the supervision of trained physiotherapists, for a period of 8 weeks. Attend monthly checkups to monitor progress and record physical health changes. The intention is to determine whether Pilates exercises are effective in improving joint stability and reducing the laxity caused by hormonal changes during pregnancy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

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

Click on a node to explore related trials.

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

July 9, 2025

Status Verified

July 1, 2025

Enrollment Period

2 months

First QC Date

November 9, 2024

Last Update Submit

July 4, 2025

Conditions

PregnancyPilates ExerciseLaxity of Ligament

Keywords

pregnancylaxitypilates training

Outcome Measures

Primary Outcomes (1)

  • Ligament laxity

    The anterior tibial translation of the knee will be considered as representative of the anterior laxity of the knee of women measured with an arthrometer ® (bilateral examination repeated 3 times on each knee).The degree of laxity will be evaluated thanks to the international classification IKDC.

    10 minutes

Secondary Outcomes (2)

  • Generalized joint hypermobility

    2 minutes

  • Physical activity level

    7 days

Study Arms (2)

Pilates Group

EXPERIMENTAL

Participants in the Pilates group attended supervised 60-minute sessions twice weekly for eight weeks, led by a certified physiotherapist trained by the Australian Institute of Pilates and Physiotherapy.

Other: Pilates trainingOther: Standard prenatal care and ergonomic advice

Control Group

OTHER

The control group received standard prenatal care and ergonomic advice, and did not participate in any exercise training.

Other: Standard prenatal care and ergonomic advice

Interventions

Pilates trainingOTHER

Participants in the Pilates group attended supervised 60-minute sessions twice weekly for eight weeks, led by a certified physiotherapist trained by the Australian Institute of Pilates and Physiotherapy.

Pilates Group
Standard prenatal care and ergonomic adviceOTHER

The control group received standard prenatal care and ergonomic advice, and did not participate in any exercise training.

Control GroupPilates Group

Eligibility Criteria

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

You may qualify if:

  • Aged between 18-35 years
  • In the 14th-16th week of pregnancy
  • Voluntary participation in the study

You may not qualify if:

  • Cardiovascular or pulmonary diseases
  • Contraindications to exercise during pregnancy
  • Prior participation in structured physical activity programs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Medipol University

Ankara, Altindag, Turkey (Türkiye)

Location

Related Publications (1)

  • Bulguroglu M, Bulguroglu HI, Degirmenci B, Suicmez S, Gevrek Aslan C, Zorlu Develik S, Atalay Guzel N. Effectiveness of a prenatal pilates program on ligamentous laxity and joint hypermobility in pregnant women: a dual-center randomized controlled trial. BMC Pregnancy Childbirth. 2025 Aug 28;25(1):897. doi: 10.1186/s12884-025-08082-1.

    PMID: 40877820DERIVED

MeSH Terms

Conditions

Joint Instability

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
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

July 9, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)