Oxygen SaturationNCT07872098
Effects of Pilates Breathing Versus Diaphragmatic Breathing on Oxygen Saturation and Heart-Rate Variability in Post-Percutaneous Coronary Intervention Patients
A study testing Pilates Breathing and Diaphragmatic breathing in people with Oxygen Saturation and Percutaneous Coronary Intervention, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Percutaneous Coronary Intervention (PCI) is a common procedure used to restore coronary blood flow in patients with coronary artery disease. Post-PCI patients may experience reduced exercise tolerance, altered breathing patterns, and autonomic imbalance, which may affect oxygen saturation and heart-rate variability… Read more about this study
- Who is it for?
- Ages 44 to 75 years
- Conditions the study is for
- Oxygen Saturation, Percutaneous Coronary Intervention
- What is being tested?
- Pilates Breathing and Diaphragmatic breathing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 11 Feb 2026to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 44 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 44-75 years (> 75 years as an "at-risk" group) (20).
- Hemodynamically stable: SBP >90 mmHg, DBP 50-100 mmHg, HR 60-100 bpm, and no ongoing chest pain or signs of acute.
- Oxygen saturation SpO₂ ≥ 92% on room air
- Able to follow simple verbal instructions and perform breathing exercises.
- Ejection fraction >35%
Who cannot join
- Ongoing myocardial ischemia, unstable angina, significant arrhythmia or requirement for inotropic/vasopressor
- Cardiogenic shock or severe heart failure (NYHA IV)
- Recent thoracic surgery or chest wall injury that limits rib expansion
- Presence of cardiac implantable electronic device (pacemaker/ICD) with pacing dependency, or implanted ventricular assist device
- Severe cognitive impairment.
- Uncontrolled hypertension (SBP > 180 mmHg or DBP > 110 mmHg) or bradycardia < 50.
- Severe anemia (Hb < 8)
- Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University Islamabad
Rawalpindi, 46000
Sana Bashir, MS-CPPT, 03218529475, drsana.bashir@fui.edu.pk
About this study
Percutaneous Coronary Intervention (PCI) is a common procedure used to restore coronary blood flow in patients with coronary artery disease. Post-PCI patients may experience reduced exercise tolerance, altered breathing patterns, and autonomic imbalance, which may affect oxygen saturation and heart-rate variability (HRV). Breathing exercises are simple, non-pharmacological interventions that may support early recovery. This randomized controlled trial aims to compare the effects of Pilates breathing and diaphragmatic breathing on oxygen saturation and HRV in hemodynamically stable post-PCI patients. A total of 36 participants will be randomly allocated into two groups using a sealed opaque envelope method. The Pilates breathing group and diaphragmatic breathing group will receive supervised breathing exercises for 2 consecutive days, with three sessions per day, in addition to routine care. Oxygen saturation will be assessed using a pulse oximeter, while HRV will be measured using a Polar H10 chest belt. Pre- and post-intervention measurements will be compared between the two groups.
Read the detailed description
Percutaneous Coronary Intervention (PCI) is a commonly performed procedure for restoring coronary blood flow in patients with coronary artery disease. Following PCI, patients may experience altered breathing patterns, reduced exercise tolerance, and changes in autonomic cardiovascular regulation, which may influence oxygen saturation and heart-rate variability (HRV) during the early recovery period. Breathing exercises are simple, safe, and non-pharmacological interventions that can be incorporated into early cardiac rehabilitation. This study aims to compare the effects of Pilates breathing and diaphragmatic breathing on oxygen saturation and heart-rate variability in hemodynamically stable patients following PCI. The study will be conducted as a parallel-arm randomized controlled trial at Fauji Foundation Hospital, Rawalpindi. A total of 36 participants will be recruited through non-probability purposive sampling and randomly allocated into two groups using sealed opaque envelopes. The Pilates breathing group will receive supervised Pilates breathing exercises, while the diaphragmatic breathing group will receive supervised diaphragmatic breathing exercises. Both groups will undergo the intervention for two consecutive days, with three sessions per day. On Day 0, each session will last 15 minutes and include 10 repetitions, while on Day 1, each session will last 20 minutes and include 15 repetitions. Routine care will continue alongside the breathing interventions. Oxygen saturation (SpO2) will be assessed using a pulse oximeter, while heart-rate variability will be measured using a Polar H10 chest belt/ECG-based HRV assessment. Heart rate, blood pressure, respiratory rate, and oxygen saturation will be monitored before and after each session. Participants will be kept blinded to group allocation. The study will include hemodynamically stable post-PCI patients aged 44-75 years who meet the predefined eligibility criteria, including SpO2 ≥92% on room air and ejection fraction greater than 35%. Patients with ongoing myocardial ischemia, unstable angina, significant arrhythmias, cardiogenic shock, severe heart failure, severe cognitive impairment, uncontrolled hypertension, severe anemia, or other specified exclusion criteria will not be included. The primary outcome will be oxygen saturation, while heart-rate variability will be assessed as a secondary outcome. The study findings will help determine the effects of Pilates breathing and diaphragmatic breathing on oxygen saturation and autonomic cardiovascular regulation during early post-PCI recovery.
- Being tested
- Pilates Breathing, Diaphragmatic breathing
- Keywords
- Pilates breathing, Diaphragmatic breathing, Heart rate variability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates BreathingProcedure or surgery
Pilates breathing is a controlled breathing technique that involves lateral rib cage expansion during inhalation and slow, active exhalation. The intervention will be administered under physiotherapist supervision for 2 consecutive days with three sessions per day in addition to routine post-PCI care.
Diaphragmatic breathingProcedure or surgery
A deep breathing method that uses the diaphragm with minimal chest movement, performed in a controlled manner for a set duration. The intervention will be performed under physiotherapist supervision in addition to routine post-PCI care
| Study group | Role | What they receive |
|---|---|---|
| Pilates Breathing group A | Experimental | Supervised Pilates breathing. Post-op Day 0: 3 sessions/day, 15 minutes/session, 10 repetitions. Post-op Day 1: 3 sessions/day, 20 minutes/session, 15 repetitions. Pre- and post-session HR, BP, RR and SpO2 will be monitored. Intervention is provided in addition to routine care. Receives: Procedure: Pilates Breathing |
| Diaphragmatic Breathing group B | Active comparator | Supervised diaphragmatic breathing. Post-op Day 0: 3 sessions/day, 15 minutes/session, 10 repetitions. Post-op Day 1: 3 sessions/day, 20 minutes/session, 15 repetitions. Pre- and post-session HR, BP, RR and SpO2 will be monitored. Intervention is provided in addition to routine care. Receives: Procedure: Diaphragmatic breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen Saturation
Oxygen saturation will be measured using a pulse oximeter before and after the intervention to compare the effects of Pilates breathing and diaphragmatic breathing in post-PCI patients.
Measured: Baseline and immediately after the 2-day intervention period
Heart-Rate Variability
Variation in time between consecutive heartbeats measured using a Polar H10 chest belt/ECG-based heart-rate sensor.
Measured: Baseline and immediately after the 2-day intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start11 Feb 2026
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxygen SaturationStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel groups: Pilates breathing intervention group and diaphragmatic breathing control/comparator group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07872098
- Sponsor's protocol ID
- AqsaKanwalCPT/FUCP-27
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pilates Breathing Versus Diaphragmatic Breathing on Oxygen Saturation and Heart-Rate Variability in Post-Percutaneous Coronary Intervention Patients
- ClinicalTrials.gov ID
- NCT07872098
- Acronym / sponsor ID
- AqsaKanwalCPT/FUCP-27
- Keywords
- Pilates breathing, Diaphragmatic breathing, Heart rate variability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 11 Feb 2026 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 13 Oct 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.
Percutaneous Coronary Intervention (PCI) is a common procedure used to restore coronary blood flow in patients with coronary artery disease. Post-PCI patients may experience reduced exercise tolerance, altered breathing patterns, and autonomic imbalance, which may affect oxygen saturation and heart-rate variability (HRV). Breathing exercises are simple, non-pharmacological interventions that may support early recovery. This randomized controlled trial aims to compare the effects of Pilates breathing and diaphragmatic breathing on oxygen saturation and HRV in hemodynamically stable post-PCI patients. A total of 36 participants will be randomly allocated into two groups using a sealed opaque envelope method. The Pilates breathing group and diaphragmatic breathing group will receive supervised breathing exercises for 2 consecutive days, with three sessions per day, in addition to routine care. Oxygen saturation will be assessed using a pulse oximeter, while HRV will be measured using a Polar H10 chest belt. Pre- and post-intervention measurements will be compared between the two groups.
Detailed description
Percutaneous Coronary Intervention (PCI) is a commonly performed procedure for restoring coronary blood flow in patients with coronary artery disease. Following PCI, patients may experience altered breathing patterns, reduced exercise tolerance, and changes in autonomic cardiovascular regulation, which may influence oxygen saturation and heart-rate variability (HRV) during the early recovery period. Breathing exercises are simple, safe, and non-pharmacological interventions that can be incorporated into early cardiac rehabilitation. This study aims to compare the effects of Pilates breathing and diaphragmatic breathing on oxygen saturation and heart-rate variability in hemodynamically stable patients following PCI. The study will be conducted as a parallel-arm randomized controlled trial at Fauji Foundation Hospital, Rawalpindi. A total of 36 participants will be recruited through non-probability purposive sampling and randomly allocated into two groups using sealed opaque envelopes. The Pilates breathing group will receive supervised Pilates breathing exercises, while the diaphragmatic breathing group will receive supervised diaphragmatic breathing exercises. Both groups will undergo the intervention for two consecutive days, with three sessions per day. On Day 0, each session will last 15 minutes and include 10 repetitions, while on Day 1, each session will last 20 minutes and include 15 repetitions. Routine care will continue alongside the breathing interventions. Oxygen saturation (SpO2) will be assessed using a pulse oximeter, while heart-rate variability will be measured using a Polar H10 chest belt/ECG-based HRV assessment. Heart rate, blood pressure, respiratory rate, and oxygen saturation will be monitored before and after each session. Participants will be kept blinded to group allocation. The study will include hemodynamically stable post-PCI patients aged 44-75 years who meet the predefined eligibility criteria, including SpO2 ≥92% on room air and ejection fraction greater than 35%. Patients with ongoing myocardial ischemia, unstable angina, significant arrhythmias, cardiogenic shock, severe heart failure, severe cognitive impairment, uncontrolled hypertension, severe anemia, or other specified exclusion criteria will not be included. The primary outcome will be oxygen saturation, while heart-rate variability will be assessed as a secondary outcome. The study findings will help determine the effects of Pilates breathing and diaphragmatic breathing on oxygen saturation and autonomic cardiovascular regulation during early post-PCI recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two parallel groups: Pilates breathing intervention group and diaphragmatic breathing control/comparator group
| Arm | Type | Receives |
|---|---|---|
| Pilates Breathing group A | Experimental | Procedure: Pilates BreathingSupervised Pilates breathing. Post-op Day 0: 3 sessions/day, 15 minutes/session, 10 repetitions. Post-op Day 1: 3 sessions/day, 20 minutes/session, 15 repetitions. Pre- and post-session HR, BP, RR and SpO2 will be monitored. Intervention is provided in addition to routine care. |
| Diaphragmatic Breathing group B | Active comparator | Procedure: Diaphragmatic breathingSupervised diaphragmatic breathing. Post-op Day 0: 3 sessions/day, 15 minutes/session, 10 repetitions. Post-op Day 1: 3 sessions/day, 20 minutes/session, 15 repetitions. Pre- and post-session HR, BP, RR and SpO2 will be monitored. Intervention is provided in addition to routine care. |
Who may qualify
- Ages
- 44 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 44-75 years (> 75 years as an "at-risk" group) (20).
- Hemodynamically stable: SBP >90 mmHg, DBP 50-100 mmHg, HR 60-100 bpm, and no ongoing chest pain or signs of acute.
- Oxygen saturation SpO₂ ≥ 92% on room air
- Able to follow simple verbal instructions and perform breathing exercises.
- Ejection fraction >35%
Key exclusion criteria (8 listed)
- Ongoing myocardial ischemia, unstable angina, significant arrhythmia or requirement for inotropic/vasopressor
- Cardiogenic shock or severe heart failure (NYHA IV)
- Recent thoracic surgery or chest wall injury that limits rib expansion
- Presence of cardiac implantable electronic device (pacemaker/ICD) with pacing dependency, or implanted ventricular assist device
- Severe cognitive impairment.
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 BreathingPilates breathing is a controlled breathing technique that involves lateral rib cage expansion during inhalation and slow, active exhalation. The intervention will be administered under physiotherapist supervision for 2 consecutive days with three sessions per day in addition to routine post-PCI care. | Procedure or surgery | Pilates Breathing group A |
| Diaphragmatic breathingA deep breathing method that uses the diaphragm with minimal chest movement, performed in a controlled manner for a set duration. The intervention will be performed under physiotherapist supervision in addition to routine post-PCI care | Procedure or surgery | Diaphragmatic Breathing group B |
Primary outcome
Oxygen Saturation
Time frame: Baseline and immediately after the 2-day intervention period
Oxygen saturation will be measured using a pulse oximeter before and after the intervention to compare the effects of Pilates breathing and diaphragmatic breathing in post-PCI patients.
Heart-Rate Variability
Time frame: Baseline and immediately after the 2-day intervention period.
Variation in time between consecutive heartbeats measured using a Polar H10 chest belt/ECG-based heart-rate sensor.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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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.
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 Breathing and Diaphragmatic breathing in people with Oxygen Saturation and Percutaneous Coronary Intervention, run by Foundation University Islamabad at 1 site in Pakistan.
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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 13 Oct 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aqsa Kanwal Siddique, MS-CPPT (03315874402, Itsaqsa025@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen Saturation (time frame: Baseline and immediately after the 2-day intervention period). The study lists 2 primary outcomes in all. 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 13 Oct 2026.