Percutaneous Coronary Intervention PatientsNCT07867431
Effects of Incentive Spirometry Versus Diaphragmatic Breathing on Oxygen Saturation and Heart-rate Variability in Post Percutaneous Coronary Intervention Patients
A study testing Incentive Spirometry and Diaphragmatic Breathing in people with Percutaneous Coronary Intervention Patients, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
This study is a two-arm randomized parallel group trial designed to compare the effects of Incentive spirometry vs diaphragmatic breathing on oxygen saturation and Heart-rate variability in hemodynamically stable post-PCI patients. Read more about this study
- Who is it for?
- Ages 44 to 75 years
- Conditions the study is for
- Percutaneous Coronary Intervention Patients
- What is being tested?
- Incentive Spirometry and Diaphragmatic Breathing
- Type of treatment
- Lifestyle or therapy programme
- 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
- Adults aged 44-75 years
- Hemodynamically stable post-PCI patients with systolic blood pressure>90 mmHg, diastolic BP 50-100mmHg Heart-rate 60-100 beats/min and no ongoing chest pain or signs of acute clinical instability.
- Oxygen saturation >92% on room air
- Able to follow simple verbal instructions and perform the breathing exercises.
- Ejection Fraction >35%
Who cannot join
- Ongoing myocardial ischemia, unstable angina, significant arrythmia or requirement for inotropic/vasopressor support.
- Cardiogenic shock or severe heart failure (NYHA class IV)
- Recent thoracic surgery or chest wall injury limiting rib expansion or deep breathing.
- Cardiac implantable electronic device (pacemaker/ICD) with pacing dependency or an implanted ventricular assist device.
- Severe cognitive impairment
- Uncontrolled hypertension(SBP>180 mmHg or DBP>110 mmHg) or bradycardia<50 beats/min.
- Severe anemia (Hb<8g/dL)
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, 0321-8529475, drsana.bashir@fui.edu.pk
About this study
This study is a two-arm randomized parallel group trial designed to compare the effects of Incentive spirometry vs diaphragmatic breathing on oxygen saturation and Heart-rate variability in hemodynamically stable post-PCI patients. Participants will be randomly allocated to either the incentive spirometry group or the diaphragmatic breathing group and will receive the allocated intervention for 2 consecutive days with three supervised sessions per day in addition to routine post-PCI care. Oxygen saturation will be assessed using a pulse oximeter and heart-rate variability will be assessed using a Polar H10 sensor at baseline and after the intervention. The study will determine whether there is a difference between two interventions in the prescribed outcome measures.
Read the detailed description
This randomized parallel group study will recruit hemodynamically stable post-PCI patients referred by cardiology at the CCU of Fauji foundation Hospital, Rawalpindi. Eligible participants will be screened according to predefined inclusion and exclusion criteria and will provide written informed consent before participation. Participants will be randomly allocated to either an incentive spirometry group or diaphragmatic breathing group using sealed opaque envelopes. Both interventions will be supervised by a physiotherapist and provided in addition to routine care for 2 consecutive days with three sessions per day. Each session will be approximately 15 minutes with 10 repetitions on post-PCI Day 0 and approximately 20 minutes with 15 repetitions on Day-1. Heart-rate , blood pressure, respiratory rate and oxygen saturation will be monitored before and after sessions. The intervention will be stopped in the presence of clinically significant symptoms or abnormal vital-sign changes and the participant will be referred to the CCU medical team when required. Oxygen saturation and heart-rate variability will be assessed at baseline and after completion of the 2-day intervention period.
- Being tested
- Incentive Spirometry, Diaphragmatic Breathing
- Keywords
- Oxygen saturation, heart-rate variability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incentive SpirometryBehavioural
Experimental: Incentive Spirometry Group A
Participants will perform incentive spirometry under physiotherapist supervision in addition to routine post-percutaneous coronary intervention care. They will sit comfortably, seal their lips around the mouthpiece, inhale slowly and deeply to raise the indicator to the prescribed target, briefly sustain inspiration, and return to normal breathing. Vital signs and oxygen saturation will be monitored before and after each session.
Post-PCI Day 0: 3 sessions/day, approximately 15 minutes/session, 10 repetitions/session.
Post-PCI Day 1: 3 sessions/day, approximately 20 minutes/session, 15 repetitions/session.
Diaphragmatic BreathingOther
Active Comparator: Diaphragmatic Breathing Group B
Participants will perform diaphragmatic breathing under physiotherapist supervision in addition to routine post-percutaneous coronary intervention care. They will be positioned comfortably with the upper chest relaxed and instructed to inhale slowly through the nose while allowing the abdomen to rise, followed by slow, controlled exhalation through pursed lips while allowing the abdomen to fall. Vital signs and oxygen saturation will be monitored before and after each session.
Post-PCI Day 0: 3 supervised sessions/day, approximately 15 minutes/session, 10 repetitions/session.
Post-PCI Day 1: 3 supervised sessions/day, approximately 20 minutes/session, 15 repetitions/session.
Vital signs and oxygen saturation will be assessed before and after each session, and the participant will be monitored throughout the intervention for tolerance and any advers
| Study group | Role | What they receive |
|---|---|---|
| Incentive Spirometry Group A | Experimental | Participants assigned to this group will perform incentive spirometry under physiotherapist supervision in addition to routine post-PCI care. Participants will sit comfortably instructed to seal the lips around mouthpiece inhale slowly and deeply through the mouthpiece to raise the indicator to the prescribed target, maintain the inspiration briefly and then relax and breathe normally. The prescribed number of sustained maximal inspirations will be performed during each supervised session. The intervention will be administered according to the study protocol with monitoring of vital signs and oxygen saturation before and after each session. . The sequence will then be reversed, completing one cycle. Post-PCI Day 0:3supervised sessions/day, approximately 15 minutes/session, 10 repetitions. Post-PCI Day-1 :3 sessions/day approximately 20 minutes/sessions, 15 repetitions. Receives: Behavioral: Incentive Spirometry |
| Diaphragmatic breathing Group B | Active comparator | Participants assigned to this group will perform diaphragmatic breathing under physiotherapist supervision in addition to routine post-PCI care. The participant will be positioned comfortably with the upper chest relaxed and instructed to inhale slowly through the nose while allowing the abdomen to rise followed by a slow controlled exhalation through pursed lips while allowing the abdomen to fall. The prescribed number of repetitions and sessions will be performed according to the study protocol with monitoring of vital signs and oxygen saturation before and after each session. Post-PCI Day 0 : 3 sessions/day approximately 15mins/session,10 repetitions. Post-PCI Day 1 :3 supervised sessions/day approximately 20 minutes/session, 15 repetitions. Receives: Other: 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 assessed using pulse oximetry and recorded as peripheral oxygen saturation (SpO₂, %). Measurements will be obtained at predefined time points according to the study protocol, including before and after each intervention session during the post-percutaneous coronary intervention period. The change in oxygen saturation from pre-intervention to post-intervention measurements will be assessed to determine the effect of the breathing intervention on oxygenation.
Measured: Baseline and immediately after completion of the 2-day intervention period
Heart-rate Variability
Heart rate variability will be assessed as a measure of autonomic cardiac function by evaluating the variation in time intervals between consecutive heartbeats. Heart rate variability will be recorded using the study-specified cardiac monitoring or electrocardiographic method at the predefined assessment time points. Changes in heart rate variability following the intervention will be compared with baseline measurements to evaluate the effect of the intervention on autonomic cardiac function during the post-percutaneous coronary intervention period.
Measured: Baseline and immediately after completion of 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 posted9 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 Percutaneous Coronary Intervention PatientsStudies 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 : Incentive Spirometry intervention group and Diaphragmatic breathing 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
- NCT07867431
- Sponsor's protocol ID
- IftikharAhmadCPT/FUCP-27
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 9 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Incentive Spirometry Versus Diaphragmatic Breathing on Oxygen Saturation and Heart-rate Variability in Post Percutaneous Coronary Intervention Patients
- ClinicalTrials.gov ID
- NCT07867431
- Acronym / sponsor ID
- IftikharAhmadCPT/FUCP-27
- Keywords
- Oxygen saturation, 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
- 9 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.
This study is a two-arm randomized parallel group trial designed to compare the effects of Incentive spirometry vs diaphragmatic breathing on oxygen saturation and Heart-rate variability in hemodynamically stable post-PCI patients. Participants will be randomly allocated to either the incentive spirometry group or the diaphragmatic breathing group and will receive the allocated intervention for 2 consecutive days with three supervised sessions per day in addition to routine post-PCI care. Oxygen saturation will be assessed using a pulse oximeter and heart-rate variability will be assessed using a Polar H10 sensor at baseline and after the intervention. The study will determine whether there is a difference between two interventions in the prescribed outcome measures.
Detailed description
This randomized parallel group study will recruit hemodynamically stable post-PCI patients referred by cardiology at the CCU of Fauji foundation Hospital, Rawalpindi. Eligible participants will be screened according to predefined inclusion and exclusion criteria and will provide written informed consent before participation. Participants will be randomly allocated to either an incentive spirometry group or diaphragmatic breathing group using sealed opaque envelopes. Both interventions will be supervised by a physiotherapist and provided in addition to routine care for 2 consecutive days with three sessions per day. Each session will be approximately 15 minutes with 10 repetitions on post-PCI Day 0 and approximately 20 minutes with 15 repetitions on Day-1. Heart-rate , blood pressure, respiratory rate and oxygen saturation will be monitored before and after sessions. The intervention will be stopped in the presence of clinically significant symptoms or abnormal vital-sign changes and the participant will be referred to the CCU medical team when required. Oxygen saturation and heart-rate variability will be assessed at baseline and after completion of the 2-day intervention period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two parallel groups : Incentive Spirometry intervention group and Diaphragmatic breathing comparator group
| Arm | Type | Receives |
|---|---|---|
| Incentive Spirometry Group A | Experimental | Behavioral: Incentive SpirometryParticipants assigned to this group will perform incentive spirometry under physiotherapist supervision in addition to routine post-PCI care. Participants will sit comfortably instructed to seal the lips around mouthpiece inhale slowly and deeply through the mouthpiece to raise the indicator to the prescribed target, maintain the inspiration briefly and then relax and breathe normally. The prescribed number of sustained maximal inspirations will be performed during each supervised session. The intervention will be administered according to the study protocol with monitoring of vital signs and oxygen saturation before and after each session. . The sequence will then be reversed, completing one cycle. Post-PCI Day 0:3supervised sessions/day, approximately 15 minutes/session, 10 repetitions. Post-PCI Day-1 :3 sessions/day approximately 20 minutes/sessions, 15 repetitions. |
| Diaphragmatic breathing Group B | Active comparator | Other: Diaphragmatic BreathingParticipants assigned to this group will perform diaphragmatic breathing under physiotherapist supervision in addition to routine post-PCI care. The participant will be positioned comfortably with the upper chest relaxed and instructed to inhale slowly through the nose while allowing the abdomen to rise followed by a slow controlled exhalation through pursed lips while allowing the abdomen to fall. The prescribed number of repetitions and sessions will be performed according to the study protocol with monitoring of vital signs and oxygen saturation before and after each session. Post-PCI Day 0 : 3 sessions/day approximately 15mins/session,10 repetitions. Post-PCI Day 1 :3 supervised sessions/day approximately 20 minutes/session, 15 repetitions. |
Who may qualify
- Ages
- 44 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 44-75 years
- Hemodynamically stable post-PCI patients with systolic blood pressure>90 mmHg, diastolic BP 50-100mmHg Heart-rate 60-100 beats/min and no ongoing chest pain or signs of acute clinical instability.
- Oxygen saturation >92% on room air
- Able to follow simple verbal instructions and perform the breathing exercises.
- Ejection Fraction >35%
Key exclusion criteria (7 listed)
- Ongoing myocardial ischemia, unstable angina, significant arrythmia or requirement for inotropic/vasopressor support.
- Cardiogenic shock or severe heart failure (NYHA class IV)
- Recent thoracic surgery or chest wall injury limiting rib expansion or deep breathing.
- Cardiac implantable electronic device (pacemaker/ICD) with pacing dependency or an 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 |
|---|---|---|
| Incentive SpirometryExperimental: Incentive Spirometry Group A Participants will perform incentive spirometry under physiotherapist supervision in addition to routine post-percutaneous coronary intervention care. They will sit comfortably, seal their lips around the mouthpiece, inhale slowly and deeply to raise the indicator to the prescribed target, briefly sustain inspiration, and return to normal breathing. Vital signs and oxygen saturation will be monitored before and after each session. Post-PCI Day 0: 3 sessions/day, approximately 15 minutes/session, 10 repetitions/session. Post-PCI Day 1: 3 sessions/day, approximately 20 minutes/session, 15 repetitions/session. | Behavioural | Incentive Spirometry Group A |
| Diaphragmatic BreathingActive Comparator: Diaphragmatic Breathing Group B Participants will perform diaphragmatic breathing under physiotherapist supervision in addition to routine post-percutaneous coronary intervention care. They will be positioned comfortably with the upper chest relaxed and instructed to inhale slowly through the nose while allowing the abdomen to rise, followed by slow, controlled exhalation through pursed lips while allowing the abdomen to fall. Vital signs and oxygen saturation will be monitored before and after each session. Post-PCI Day 0: 3 supervised sessions/day, approximately 15 minutes/session, 10 repetitions/session. Post-PCI Day 1: 3 supervised sessions/day, approximately 20 minutes/session, 15 repetitions/session. Vital signs and oxygen saturation will be assessed before and after each session, and the participant will be monitored throughout the intervention for tolerance and any advers | Other | Diaphragmatic breathing Group B |
Primary outcome
Oxygen saturation
Time frame: Baseline and immediately after completion of the 2-day intervention period
Oxygen saturation will be assessed using pulse oximetry and recorded as peripheral oxygen saturation (SpO₂, %). Measurements will be obtained at predefined time points according to the study protocol, including before and after each intervention session during the post-percutaneous coronary intervention period. The change in oxygen saturation from pre-intervention to post-intervention measurements will be assessed to determine the effect of the breathing intervention on oxygenation.
Heart-rate Variability
Time frame: Baseline and immediately after completion of the 2-day intervention period.
Heart rate variability will be assessed as a measure of autonomic cardiac function by evaluating the variation in time intervals between consecutive heartbeats. Heart rate variability will be recorded using the study-specified cardiac monitoring or electrocardiographic method at the predefined assessment time points. Changes in heart rate variability following the intervention will be compared with baseline measurements to evaluate the effect of the intervention on autonomic cardiac function during the post-percutaneous coronary intervention period.
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 9 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 Incentive Spirometry and Diaphragmatic Breathing in people with Percutaneous Coronary Intervention Patients, 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 7 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 9 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 Iftikhar Ahmad, MS-CPPT (0334-1920385, iftkharrahmad014@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 completion of 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 9 Oct 2026.