NCT07578714

Brief Summary

This study aims to compare core muscle stability, postural balance, and flexibility between healthy women who regularly practice Pilates and those with a sedentary lifestyle. The researcher will evaluate if long-term Pilates practice (5 months or more) leads to significant improvements in physical performance compared to a lack of regular exercise. Assessment tools include the Pressure Biofeedback Unit (PBU) for core activation, the McGill battery for endurance, the Y-Balance test for dynamic stability, and the Sit-and-Reach test for flexibility.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
10mo left

Started May 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress3%
May 2026Mar 2027

First Submitted

Initial submission to the registry

May 3, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 11, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

May 13, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2027

Last Updated

May 11, 2026

Status Verified

May 1, 2026

Enrollment Period

10 months

First QC Date

May 3, 2026

Last Update Submit

May 5, 2026

Conditions

Keywords

PilatesFlexibilityTrunk Muscle EnduranceWomen's HealthSedentary BehaviorPressure Biofeedback Unit (PBU)Y-Balance TestMcGill Battery

Outcome Measures

Primary Outcomes (3)

  • Deep Muscle Stabilization Pressure Biofeedback Device - PBU

    Measurement of the transversus abdominis muscle activation using a Pressure Biofeedback Unit (PBU).isolation is confirmed by a drop in pressure of 4-10 mmHg from a 70 mmHg baseline, sustained for 10 seconds in prone position.

    At the single assessment session (Day 1)

  • Core Muscle Endurance

    Measured using the McGill Core Endurance Battery, including the Trunk Flexor, Trunk Extensor, and Side Bridge tests. Results are recorded as the duration (in seconds) the position is maintained.

    At the single assessment session (Day 1)

  • Dynamic Postural Balance Y-Balance Test (YBT)

    Assessed using the Y-Balance Test (YBT). The maximum reach distance in three directions (Anterior, Posteromedial, and Posterolateral) will be recorded in centimeters

    At the single assessment session (Day 1)

Secondary Outcomes (2)

  • Static Postural Balance Test or Single Leg Standing Test (SLST)

    At the single assessment session (Day 1)

  • Lower Back and Hamstring Flexibility

    At the single assessment session (Day 1)

Study Arms (2)

Pilates Group

Healthy women who have regularly practiced Pilates exercises for at least 5 months, with a minimum of two sessions per week.

Sedentary Group

Healthy women with a sedentary lifestyle, defined as having less than 150 minutes of physical activity per week and no regular exercise routine in the past 3 months.

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy adult women from the general community and Pilates studios in Istanbul, Turkey.

You may qualify if:

  • Healthy female volunteers aged 20-45.
  • For the Pilates group: having practiced mat Pilates, reformer Pilates, or any equipment-based Pilates discipline for at least 6 months; attending regular 60-minute sessions at least twice a week with a certified instructor.
  • For the control group: having a sedentary lifestyle (weekly moderate physical activity time less than 150 minutes).
  • Objectively demonstrating sedentary status using the International Physical Activity Questionnaire (IPAQ); only participants in the "low physical activity" category will be included in the control group.
  • Having full cognitive ability to understand, follow, and execute all physical assessment instructions.
  • Willingness to voluntarily sign the informed consent form prior to the study.

You may not qualify if:

  • History of any surgery involving the spine, pelvis, or lower extremities within the last 12 months prior to the study.
  • Currently pregnant or less than 6 months postpartum.
  • Diagnosed vestibular disorders or chronic clinical balance disorders.
  • History of neurological disease (MS, Parkinson's, etc.) or systemic metabolic disorder (diabetes, etc.).
  • Having a pain intensity greater than 2/10 on the visual analog scale (VAS) in the lower back or lower extremities.
  • Professional sports history or participation in other exercise programs exceeding 3 hours per week (excluding Pilates for the Pilates group).
  • Acute musculoskeletal injuries or acute illnesses that may affect energy levels on the day of evaluation.
  • Concurrent participation in other intensive core strengthening programs such as "advanced yoga" that may affect results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istinye University, Topkapi Campus

Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)

RECRUITING

Related Publications (4)

  • Alshehre Y, Alkhathami K, Brizzolara K, Weber M, Wang-Price S. Reliability and Validity of the Y-balance Test in Young Adults with Chronic Low Back Pain. Int J Sports Phys Ther. 2021 Jun 1;16(3):628-635. doi: 10.26603/001c.23430.

    PMID: 34123515BACKGROUND
  • Fallahasady E, Rahmanloo N, Seidi F, Rajabi R, Bayattork M. The relationship between core muscle endurance and functional movement screen scores in females with lumbar hyperlordosis: a cross-sectional study. BMC Sports Sci Med Rehabil. 2022 Oct 13;14(1):182. doi: 10.1186/s13102-022-00567-2.

  • De Blaiser C, Roosen P, Willems T, De Bleecker C, Vermeulen S, Danneels L, De Ridder R. The role of core stability in the development of non-contact acute lower extremity injuries in an athletic population: A prospective study. Phys Ther Sport. 2021 Jan;47:165-172. doi: 10.1016/j.ptsp.2020.11.035. Epub 2020 Nov 30.

  • Wells C, Kolt GS, Bialocerkowski A. Defining Pilates exercise: a systematic review. Complement Ther Med. 2012 Aug;20(4):253-62. doi: 10.1016/j.ctim.2012.02.005. Epub 2012 Mar 13.

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • NALAN Soydaş, PhD

    Istinye University

    STUDY DIRECTOR

Central Study Contacts

WALA Abbas Mohammed TAHA, PT specialist

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical therapy specialist and Master's student

Study Record Dates

First Submitted

May 3, 2026

First Posted

May 11, 2026

Study Start

May 13, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 13, 2027

Last Updated

May 11, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared to ensure the privacy and confidentiality of the participants, as per the ethical approval guidelines of Istinye University. The aggregated results will be published as part of the Master's thesis and potential academic publications.

Locations