NCT07867457

Brief Summary

This study is a two-arm randomized parallel group trial designed to compare the effects of alternate nostril breathing vs diaphragmatic breathing on oxygen saturation and Heart-rate variability in hemodynamically stable post-PCI patients. Participants will be randomly allocated in a 1:1 ratio to alternate nostril breathing or diaphragmatic breathing 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 breathing interventions in the prescribed outcome measures.

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 Progress79%
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 5, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 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 9, 2026

Status Verified

October 1, 2026

Enrollment Period

10 months

First QC Date

October 5, 2026

Last Update Submit

October 5, 2026

Conditions

Keywords

Oxygen saturationheart-rate

Outcome Measures

Primary Outcomes (2)

  • Change in Oxygen saturation

    Change in peripheral oxygen saturation (SpO₂) from baseline to the specified post-intervention assessment time point, measured using a pulse oximeter. Oxygen saturation will be recorded as a percentage (%) and compared between baseline and post-intervention measurements.

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

  • Change in Heart Rate Variability (HRV)

    Change in heart rate variability from baseline to the specified post-intervention assessment time point, assessed using a validated heart rate/ECG monitoring device. Heart rate variability will be evaluated using predefined HRV parameters, such as time-domain and/or frequency-domain measures, as applicable to the study protocol.

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

Study Arms (2)

Alternate Nostril breathing Group A

EXPERIMENTAL

Participants assigned to this group will perform alternate nostril breathing under physiotherapist supervision in addition to routine post-PCI care. Participants will sit comfortably with spine straight and shoulders relaxed. The right nostril will be closed with the right thumb and inhalation will be performed through the left nostril. The left nostril will then be closed with the right ring finger ,the right nostril released and exhalation performed through the right nostril. 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: Alternate Nostril Breathing

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 lie supine or sit upright with the back supported, with one hand on the upper chest and the other on the abdomen below the rib cage. The participant will inhale slowly through the nose while allowing the abdomen to rise and then exhale slowly through pursed lips while allowing the abdomen to fall. 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

Non-pharmacological breathing interventions administered under physiotherapist supervision for 2 consecutive days with three sessions per day in addition to routine post-PCI care.

Alternate Nostril breathing Group A

Participants assigned to this group will perform diaphragmatic breathing under physiotherapist supervision in addition to routine post-PCI care. The participant will lie supine or sit upright with the back supported, with one hand on the upper chest and the other on the abdomen below the rib cage. The participant will inhale slowly through the nose while allowing the abdomen to rise and then exhale slowly through pursed lips while allowing the abdomen to fall. 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.

Diaphragmatic breathing Group B

Eligibility Criteria

Age44 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University Islamabad

Rawalpindi, 46000, Pakistan

RECRUITING

Central Study Contacts

Sonia Jahangir, 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
The study protocol specifies single masking of participants, participants will not be informed of the allocation details.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two parallel groups : Alternate nostril breathing intervention group and Diaphragmatic breathing comparator group
Sponsor Type
OTHER
Responsible Party
SPONSOR

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