- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07650929
Pilates With Diaphragmatic Breathing in Sedentary Women (PDB-Pilates)
June 11, 2026 updated by: Veli Volkan Gürses, Bandırma Onyedi Eylül University
Effects of Pilates Combined With Diaphragmatic Breathing on Cardiopulmonary Markers in Sedentary Women: A Randomized Controlled Trial
This randomized controlled trial evaluated whether adding diaphragmatic breathing exercises to an eight-week supervised Pilates program improves pulmonary function, resting heart rate, and core endurance in sedentary women aged 35 years and older.
Participants were randomized to Pilates combined with diaphragmatic breathing or Pilates alone.
Both groups trained three times per week for eight weeks.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Participants were sedentary women aged 35 years and older who had not participated in regular structured exercise during the previous six months.
Participants were randomly assigned in a 1:1 ratio to either Pilates combined with diaphragmatic breathing exercises or Pilates alone.
Both groups completed supervised exercise sessions three times per week for eight weeks.
Each session lasted approximately 60 minutes and included warm-up, main Pilates exercises, and cool-down.
The experimental group additionally performed structured diaphragmatic and abdominal breathing exercises integrated into the Pilates sessions.
Pulmonary function, cardiovascular parameters, functional performance, anthropometry, and echocardiographic safety parameters were assessed at baseline and after the intervention.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bandırma
-
Balıkesir, Bandırma, Turkey (Türkiye), 10010
- Bandirma Onyedi Eylul University, Faculty of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Female participants aged 35 years or older
- Sedentary status, defined as no regular structured exercise participation during the previous six months
- Non-smoker
- No diagnosed cardiovascular, pulmonary, or musculoskeletal disorder
- Not using medications known to influence cardiopulmonary function
- Provided written informed consent
Exclusion Criteria:
- Pregnancy
- Recent surgery or injury
- Participation in another structured exercise program during the study period
- Any cardiovascular, pulmonary, or musculoskeletal condition that could affect safe participation
- Use of medication known to influence cardiopulmonary function
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pilates Exercise Diaphragmatic Breathing Exercise
Participants completed an eight-week supervised Pilates program combined with structured diaphragmatic and abdominal breathing exercises.
Sessions were performed three times per week and lasted approximately 60 minutes.
|
Participants completed a supervised mat-based Pilates exercise program three times per week for eight weeks.
Each session lasted approximately 60 minutes and included a warm-up phase, a main Pilates exercise component targeting core stability, flexibility, postural alignment, and muscular endurance, and a cool-down phase.
Participants performed structured diaphragmatic and abdominal breathing exercises integrated into the Pilates sessions.
The breathing protocol included slow nasal inhalation, controlled oral exhalation, abdominal expansion, segmental thoracic breathing, and guided breathing rhythm during selected Pilates exercises.
|
|
Active Comparator: Pilates Alone
Participants completed the same eight-week supervised Pilates program without specific diaphragmatic breathing instruction.
Sessions were performed three times per week and lasted approximately 60 minutes.
|
Participants completed a supervised mat-based Pilates exercise program three times per week for eight weeks.
Each session lasted approximately 60 minutes and included a warm-up phase, a main Pilates exercise component targeting core stability, flexibility, postural alignment, and muscular endurance, and a cool-down phase.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Peak Expiratory Flow
Time Frame: Baseline and after 8 weeks
|
Peak expiratory flow was assessed by spirometry.
The change from baseline to the end of the eight-week intervention was evaluated.
|
Baseline and after 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Forced Vital Capacity
Time Frame: Baseline and after 8 weeks
|
Forced vital capacity was assessed by spirometry.
|
Baseline and after 8 weeks
|
|
Change in Forced Expiratory Volume in One Second
Time Frame: Baseline and after 8 weeks
|
FEV1 was assessed by spirometry.
|
Baseline and after 8 weeks
|
|
Change in FEV1/FVC Ratio
Time Frame: Baseline and after 8 weeks
|
The FEV1/FVC ratio was calculated from spirometric measurements.
|
Baseline and after 8 weeks
|
|
Change in Resting Heart Rate
Time Frame: Baseline and after 8 weeks
|
Resting heart rate was measured after at least 10 minutes of seated rest.
|
Baseline and after 8 weeks
|
|
Change in Plank Test Performance
Time Frame: Baseline and after 8 weeks
|
Core muscular endurance was assessed using the prone plank test, recorded in seconds.
|
Baseline and after 8 weeks
|
|
Change in Echocardiographic Safety Parameters
Time Frame: Baseline and after 8 weeks
|
Echocardiographic parameters including ejection fraction, ventricular dimensions, wall thickness, and flow velocities were evaluated for safety monitoring.
|
Baseline and after 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: DUYGU DURMAZ, PHD, Bandirma Onyedi Eylul University, Faculty of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 3, 2025
Primary Completion (Actual)
September 5, 2025
Study Completion (Actual)
October 7, 2025
Study Registration Dates
First Submitted
June 11, 2026
First Submitted That Met QC Criteria
June 11, 2026
First Posted (Actual)
June 16, 2026
Study Record Updates
Last Update Posted (Actual)
June 16, 2026
Last Update Submitted That Met QC Criteria
June 11, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- BANU-PILATES-DB-2025-76
- Other Identifier (Other Identifier: 2025-76)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified individual participant data underlying the results reported in the article will be made available upon reasonable request.
IPD Sharing Time Frame
Beginning after publication and available for 5 years.
IPD Sharing Access Criteria
Data will be shared with researchers who submit a methodologically sound proposal and obtain approval from the corresponding author and, if required, the institutional ethics committee.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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