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RECRUITING Not applicable ClinicalTrials.gov

Effects of Incentive Spirometry Versus Diaphragmatic Breathing on Oxygen Saturation and Heart-rate Variability in Post Percutaneous Coronary Intervention Patients

Sponsor: Foundation University Islamabad • ClinicalTrials.gov ID: NCT07867431

Registry updated: 2026-10-09
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Description

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.

Interventions

  • Incentive Spirometry (Behavioral)
    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 Breathing (Other)
    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

Eligibility criteria

Inclusion Criteria: * 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% Exclusion Criteria: * 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)

Conditions

Percutaneous Coronary Intervention Patients

Locations

  • Foundation University Islamabad — Rawalpindi, Pakistan
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record