NCT07652229

Brief Summary

This randomized controlled study aims to investigate the effects of diaphragmatic breathing exercises on core stabilization muscle strength, peak expiratory flow (PEF), and chest expansion in women performing equipment-based Pilates. A total of 44 healthy women aged 20 to 50 years who regularly participate in equipment-based Pilates exercises will be recruited and randomly assigned to one of two groups. The intervention group will receive equipment-based Pilates training combined with diaphragmatic breathing exercises, while the control group will receive equipment-based Pilates training only. Both groups will participate in supervised exercise sessions twice weekly for 8 weeks. Core stabilization muscle strength, peak expiratory flow, and chest expansion measurements will be assessed before and after the intervention period. The findings of this study may contribute to a better understanding of the additional effects of diaphragmatic breathing exercises on respiratory function and core stabilization in women performing Pilates.

Trial Health

63
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Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress6%
Jun 2026Aug 2026

First Submitted

Initial submission to the registry

June 11, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

June 15, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2026

Expected
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2026

Last Updated

June 17, 2026

Status Verified

June 1, 2026

Enrollment Period

2 months

First QC Date

June 11, 2026

Last Update Submit

June 11, 2026

Conditions

Keywords

PilatesEquipment-Based PilatesDiaphragmatic BreathingCore StabilityPeak Expiratory FlowChest ExpansionRespiratory Function

Outcome Measures

Primary Outcomes (2)

  • Core Stabilization Muscle Strength

    Core stabilization muscle strength assessed using a Pressure Biofeedback Unit (PBU).

    Baseline and 8 weeks

  • Peak Expiratory Flow (PEF)

    Peak expiratory flow measured using a peak flow meter and recorded in liters per minute (L/min).

    Baseline and 8 weeks

Secondary Outcomes (1)

  • Chest Expansion

    Baseline and 8 weeks

Study Arms (2)

Pilates + Diaphragmatic Breathing

EXPERIMENTAL

Participants received equipment-based Pilates training combined with diaphragmatic breathing exercises twice weekly for 8 weeks. Each session lasted approximately 50 minutes and was supervised by the same physiotherapist.

Behavioral: Diaphragmatic Breathing ExerciseBehavioral: Equipment-Based Pilates Training

Pilates Only

ACTIVE COMPARATOR

Participants received equipment-based Pilates training twice weekly for 8 weeks.

Behavioral: Equipment-Based Pilates Training

Interventions

Participants performed diaphragmatic breathing exercises twice weekly for 8 weeks under the supervision of a physiotherapist. The breathing exercises focused on diaphragmatic activation and controlled breathing patterns and were integrated into the Pilates training sessions.

Pilates + Diaphragmatic Breathing

Participants received equipment-based Pilates training twice weekly for 8 weeks. Each session lasted approximately 50 minutes and was supervised by the same physiotherapist. The program focused on core stabilization, posture, flexibility, and muscle strengthening.

Pilates + Diaphragmatic BreathingPilates Only

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly women who self-identify as female and meet the study eligibility criteria were eligible to participate in this study.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female participants aged 20-50 years. Healthy individuals regularly performing equipment-based Pilates exercises. Willingness to participate voluntarily and provide informed consent. Ability to attend Pilates sessions twice weekly for 8 weeks.

You may not qualify if:

  • History of spinal trauma or surgery within the previous 6 months. Pregnancy. Diabetes mellitus or other systemic diseases. Respiratory or musculoskeletal disorders that may affect participation or outcome measurements.
  • Cognitive or physical limitations preventing compliance with the study protocol.
  • Failure to attend scheduled sessions or complete the intervention protocol. Development of pain, injury, or any medical condition requiring discontinuation during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeşim Dokuzluoğlu Private Pilates Studio

Istanbul, Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gözde Başbuğ, PhD, PT

    Istanbul Aydın University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nava Mokhtari, PT, MSc

CONTACT

Gözde Başbuğ, PhD, PT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of two parallel groups. The intervention group will receive equipment-based Pilates exercises combined with diaphragmatic breathing exercises, while the control group will receive equipment-based Pilates exercises only. Both groups will participate in supervised sessions twice weekly for 8 weeks. Outcome measures will be assessed before and after the intervention period.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc Student, Physiotherapist

Study Record Dates

First Submitted

June 11, 2026

First Posted

June 17, 2026

Study Start

June 15, 2026

Primary Completion (Estimated)

August 10, 2026

Study Completion (Estimated)

August 15, 2026

Last Updated

June 17, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations