An interventional study of Incentive Spirometry and Diaphragmatic Breathing in Percutaneous Coronary Intervention Patients, sponsored by Foundation University Islamabad. Recruiting at 1 site in Pakistan. Open to participants aged 44 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Foundation University Islamabad · Not applicable, Interventional, and Treatment
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.
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.
Foundation University Islamabad is the lead sponsor of 253 studies on the registry; 140 are open to participants now.
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Exclusion Criteria:
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.
Behavioral: Incentive Spirometry
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.
Other: Diaphragmatic Breathing
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.
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
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.
Time frame: 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.
Time frame: Baseline and immediately after completion of the 2-day intervention period.
Started Feb 2026 (actual). Primary completion is estimated for Dec 2026, 10 months after the start.
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