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

NCT07867431 | Recruiting

• 1 other identifier: IftikharAhmadCPT/FUCP-27
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Percutaneous Coronary Intervention Patients

Keywords

Oxygen saturation; heart-rate variability

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline and immediately after completion of the 2-day intervention period.

Study Arms (2)

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.

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.

Other: Diaphragmatic Breathing

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.

Incentive Spirometry Group A

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

Diaphragmatic breathing Group B

Eligibility Criteria

• Age: 44 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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)

Sponsors & Collaborators

• Foundation University Islamabad: lead

Study Sites (1)

Foundation University Islamabad

Rawalpindi, 46000, Pakistan

RECRUITING

Central Study Contacts

Iftikhar Ahmad, MS-CPPT

CONTACT

0334-1920385; iftkharrahmad014@gmail.com

Sana Bashir, MS-CPPT

CONTACT

0321-8529475; drsana.bashir@fui.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The study protocol specifies single masking of participants, participants will not be informed of the allocation details.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two parallel groups : Incentive Spirometry intervention group and Diaphragmatic breathing comparator group

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 9, 2026
• Study Start: February 11, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: October 9, 2026

Record last verified: 2026-10

Locations

PA (1)