NCT07872098

Brief Summary

Percutaneous Coronary Intervention (PCI) is a common procedure used to restore coronary blood flow in patients with coronary artery disease. Post-PCI patients may experience reduced exercise tolerance, altered breathing patterns, and autonomic imbalance, which may affect oxygen saturation and heart-rate variability (HRV). Breathing exercises are simple, non-pharmacological interventions that may support early recovery. This randomized controlled trial aims to compare the effects of Pilates breathing and diaphragmatic breathing on oxygen saturation and HRV in hemodynamically stable post-PCI patients. A total of 36 participants will be randomly allocated into two groups using a sealed opaque envelope method. The Pilates breathing group and diaphragmatic breathing group will receive supervised breathing exercises for 2 consecutive days, with three sessions per day, in addition to routine care. Oxygen saturation will be assessed using a pulse oximeter, while HRV will be measured using a Polar H10 chest belt. Pre- and post-intervention measurements will be compared between the two groups.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress83%
Feb 2026Dec 2026

Study Start

First participant enrolled

February 11, 2026

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 13, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Last Updated

October 13, 2026

Status Verified

October 1, 2026

Enrollment Period

10 months

First QC Date

October 7, 2026

Last Update Submit

October 7, 2026

Conditions

Keywords

Pilates breathingDiaphragmatic breathingHeart rate variability

Outcome Measures

Primary Outcomes (2)

  • Oxygen Saturation

    Oxygen saturation will be measured using a pulse oximeter before and after the intervention to compare the effects of Pilates breathing and diaphragmatic breathing in post-PCI patients.

    Baseline and immediately after the 2-day intervention period

  • Heart-Rate Variability

    Variation in time between consecutive heartbeats measured using a Polar H10 chest belt/ECG-based heart-rate sensor.

    Baseline and immediately after the 2-day intervention period.

Study Arms (2)

Pilates Breathing group A

EXPERIMENTAL

Supervised Pilates breathing. Post-op Day 0: 3 sessions/day, 15 minutes/session, 10 repetitions. Post-op Day 1: 3 sessions/day, 20 minutes/session, 15 repetitions. Pre- and post-session HR, BP, RR and SpO2 will be monitored. Intervention is provided in addition to routine care.

Procedure: Pilates Breathing

Diaphragmatic Breathing group B

ACTIVE COMPARATOR

Supervised diaphragmatic breathing. Post-op Day 0: 3 sessions/day, 15 minutes/session, 10 repetitions. Post-op Day 1: 3 sessions/day, 20 minutes/session, 15 repetitions. Pre- and post-session HR, BP, RR and SpO2 will be monitored. Intervention is provided in addition to routine care.

Procedure: Diaphragmatic breathing

Interventions

Pilates breathing is a controlled breathing technique that involves lateral rib cage expansion during inhalation and slow, active exhalation. The intervention will be administered under physiotherapist supervision for 2 consecutive days with three sessions per day in addition to routine post-PCI care.

Pilates Breathing group A

A deep breathing method that uses the diaphragm with minimal chest movement, performed in a controlled manner for a set duration. The intervention will be performed under physiotherapist supervision in addition to routine post-PCI care

Diaphragmatic Breathing group B

Eligibility Criteria

Age44 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 44-75 years (\> 75 years as an "at-risk" group) (20).
  • Hemodynamically stable: SBP \>90 mmHg, DBP 50-100 mmHg, HR 60-100 bpm, and no ongoing chest pain or signs of acute.
  • Oxygen saturation SpO₂ ≥ 92% on room air
  • Able to follow simple verbal instructions and perform breathing exercises.
  • Ejection fraction \>35%

You may not qualify if:

  • Ongoing myocardial ischemia, unstable angina, significant arrhythmia or requirement for inotropic/vasopressor
  • Cardiogenic shock or severe heart failure (NYHA IV)
  • Recent thoracic surgery or chest wall injury that limits rib expansion
  • Presence of cardiac implantable electronic device (pacemaker/ICD) with pacing dependency, or implanted ventricular assist device
  • Severe cognitive impairment.
  • Uncontrolled hypertension (SBP \> 180 mmHg or DBP \> 110 mmHg) or bradycardia \< 50.
  • Severe anemia (Hb \< 8)
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University Islamabad

Rawalpindi, 46000, Pakistan

RECRUITING

Central Study Contacts

Aqsa Kanwal Siddique, MS-CPPT

CONTACT

Sana Bashir, MS-CPPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be randomly assigned to either the Pilates breathing group or diaphragmatic breathing group using sealed opaque envelopes, and participants will not be informed about their specific group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two parallel groups: Pilates breathing intervention group and diaphragmatic breathing control/comparator group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2026

First Posted

October 13, 2026

Study Start

February 11, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 15, 2026

Last Updated

October 13, 2026

Record last verified: 2026-10

Locations