About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Incentive Spirometry
BehavioralExperimental: 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 Breathing
Other interventionActive 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
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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