Sedentary Behavior Pulmonary Function Cardiopulmonary FitnessPDB-PilatesNCT07650929
Pilates With Diaphragmatic Breathing in Sedentary Women
A study testing Pilates Exercise Program and Diaphragmatic Breathing Exercise in people with Sedentary Behavior Pulmonary Function Cardiopulmonary Fitness, run by Bandırma Onyedi Eylül University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior Pulmonary Function Cardiopulmonary Fitness
- What is being tested?
- Pilates Exercise Program and Diaphragmatic Breathing Exercise
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jun 2025to 7 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bandirma Onyedi Eylul University, Faculty of Medicine
Balıkesir, Bandırma, 10010
About this study
Official title: 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.
Read the 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.
- Being tested
- Pilates Exercise Program, Diaphragmatic Breathing Exercise
- Keywords
- Pilates Diaphragmatic Breathing Pulmonary Function Sedentary Women Resting Heart Rate Core Endurance Peak Expiratory Flow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates Exercise ProgramBehavioural
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.
Diaphragmatic Breathing ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Pilates Exercise Diaphragmatic Breathing Exercise | Experimental | 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. Receives: Behavioral: Pilates Exercise Program; Behavioral: Diaphragmatic Breathing Exercise |
| Pilates Alone | Active comparator | 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. Receives: Behavioral: Pilates Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Peak Expiratory Flow
Peak expiratory flow was assessed by spirometry. The change from baseline to the end of the eight-week intervention was evaluated.
Measured: Baseline and after 8 weeks
Secondary outcomes (6)
Change in Forced Vital Capacity
Forced vital capacity was assessed by spirometry.
Measured: Baseline and after 8 weeks
Change in Forced Expiratory Volume in One Second
FEV1 was assessed by spirometry.
Measured: Baseline and after 8 weeks
Change in FEV1/FVC Ratio
The FEV1/FVC ratio was calculated from spirometric measurements.
Measured: Baseline and after 8 weeks
Change in Resting Heart Rate
Resting heart rate was measured after at least 10 minutes of seated rest.
Measured: Baseline and after 8 weeks
Change in Plank Test Performance
Core muscular endurance was assessed using the prone plank test, recorded in seconds.
Measured: Baseline and after 8 weeks
Change in Echocardiographic Safety Parameters
Echocardiographic parameters including ejection fraction, ventricular dimensions, wall thickness, and flow velocities were evaluated for safety monitoring.
Measured: Baseline and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start3 Jun 2025
- Primary completion5 Sep 2025
- Study completion7 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary Behavior Pulmonary Function Cardiopulmonary FitnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized in a 1:1 ratio to one of two parallel intervention groups. The experimental group completed a supervised Pilates program combined with structured diaphragmatic breathing exercises, whereas the active comparator group completed the same supervised Pilates program without specific diaphragmatic breathing instruction. Both groups trained three times per week for eight weeks. Outcomes were assessed at baseline and after the intervention by assessors blinded to group allocation.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bandırma Onyedi Eylül University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veli Volkan Gürses, Bandırma Onyedi Eylül University
- Investigators
- DUYGU DURMAZ, PHD, Principal investigator, Bandirma Onyedi Eylul University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07650929
- Sponsor's protocol ID
- BANU-PILATES-DB-2025-76
- Other IDs
- Other Identifier
- Acronym
- PDB-Pilates
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the article will be made available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pilates Combined With Diaphragmatic Breathing on Cardiopulmonary Markers in Sedentary Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07650929
- Acronym / sponsor ID
- PDB-Pilates / BANU-PILATES-DB-2025-76
- Keywords
- Pilates Diaphragmatic Breathing Pulmonary Function Sedentary Women Resting Heart Rate Core Endurance Peak Expiratory Flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Bandırma Onyedi Eylül UniversityUniversity, hospital or other
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- 5 Sep 2025 (actual)
- Study completion
- 7 Oct 2025 (actual)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomized in a 1:1 ratio to one of two parallel intervention groups. The experimental group completed a supervised Pilates program combined with structured diaphragmatic breathing exercises, whereas the active comparator group completed the same supervised Pilates program without specific diaphragmatic breathing instruction. Both groups trained three times per week for eight weeks. Outcomes were assessed at baseline and after the intervention by assessors blinded to group allocation.
| Arm | Type | Receives |
|---|---|---|
| Pilates Exercise Diaphragmatic Breathing Exercise | Experimental | Behavioral: Pilates Exercise Program, Behavioral: Diaphragmatic Breathing ExerciseParticipants 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. |
| Pilates Alone | Active comparator | Behavioral: Pilates Exercise ProgramParticipants 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. |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilates Exercise ProgramParticipants 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. | Behavioural | Pilates Alone, Pilates Exercise Diaphragmatic Breathing Exercise |
| Diaphragmatic Breathing ExerciseParticipants 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. | Behavioural | Pilates Exercise Diaphragmatic Breathing Exercise |
Primary outcome
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.
6 secondary outcomes
Change in Forced Vital Capacity
Time frame: Baseline and after 8 weeks
Change in Forced Expiratory Volume in One Second
Time frame: Baseline and after 8 weeks
Change in FEV1/FVC Ratio
Time frame: Baseline and after 8 weeks
Change in Resting Heart Rate
Time frame: Baseline and after 8 weeks
Change in Plank Test Performance
Time frame: Baseline and after 8 weeks
Change in Echocardiographic Safety Parameters
Time frame: Baseline and after 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the article will be made available upon reasonable request.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DUYGU DURMAZ, PHD principal investigator
Bandirma Onyedi Eylul University, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates Exercise Program and Diaphragmatic Breathing Exercise in people with Sedentary Behavior Pulmonary Function Cardiopulmonary Fitness, run by Bandırma Onyedi Eylül University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Peak Expiratory Flow (time frame: Baseline and after 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.