NCT07759583

Brief Summary

The current study will be a single-blind, parallel-group randomized controlled trial involving 62 patients diagnosed with smog-induced pneumonia. The study will compare the effects of Buteyko Breathing Technique (BBT) with Incentive Spirometry (IS) on respiratory outcomes. Participants will be randomly assigned to two groups using a concealed allocation method. The experimental group will receive Buteyko Breathing Technique along with standard medical care, while the control group will receive Incentive Spirometry along with standard medical care. Both interventions will be performed twice daily for approximately 20-30 minutes per session for seven days or until hospital discharge. Primary outcomes will include oxygen saturation (SpO₂), dyspnoea severity, exercise tolerance, sputum clearance, and respiratory symptom burden. Assessments will be conducted at baseline (Day 0), mid-intervention (Day 3), post-intervention (Week 2), and follow-up (Week 4). The study will be conducted at the pulmonary wards of Combined Military Hospital (CMH) and The Indus Hospital, Lahore. The hypothesis is that Buteyko Breathing Technique may produce greater improvements in oxygen saturation, dyspnoea reduction, exercise tolerance, and sputum clearance compared with Incentive Spirometry in patients with smog-induced pneumonia.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started May 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 Progress63%
May 2026Oct 2026

Study Start

First participant enrolled

May 1, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 12, 2026

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2026

Last Updated

August 12, 2026

Status Verified

August 1, 2026

Enrollment Period

4 months

First QC Date

July 23, 2026

Last Update Submit

August 6, 2026

Conditions

Keywords

Buteyko Breathing TechniqueIncentive SpirometryOxygen saturationPulmonary RehabilitationSmog-induced Pneumonia

Outcome Measures

Primary Outcomes (5)

  • Peripheral Oxygen Saturation (SpO₂)

    Peripheral oxygen saturation (SpO₂) will be measured at rest using a fingertip pulse oximeter. SpO₂ is reported as a percentage (%) ranging from 0% to 100%, with higher values indicating better oxygenation status. Normal resting values are typically 95%-100%.

    Baseline (Day 0), Day 3, Week 2, and Week 4 follow-up.

  • Six-Minute Walk Distance (6MWD)

    Functional exercise capacity will be assessed using the Six-Minute Walk Test (6MWT) according to the American Thoracic Society guidelines. The outcome will be reported as the total distance walked in six minutes, measured in meters (m). Greater walking distance indicates better functional exercise capacity.

    Baseline (Day 0), Day 3, Week 2, and Week 4 follow-up.

  • Sputum Wet Weight

    Sputum production will be measured as sputum wet weight (grams) using pre-weighed sterile collection containers and a calibrated digital weighing scale. Results will be reported in grams (g). Higher values indicate greater sputum production, whereas lower values indicate improvement.

    Baseline (Day 0), Day 3, Week 2, and Week 4 follow-up.

  • Dyspnoea Severity Score (Modified Borg Dyspnoea Scale)

    Dyspnoea severity will be assessed using the Modified Borg Dyspnoea Scale. The scale ranges from 0 (no breathlessness) to 10 (maximal breathlessness). Higher scores indicate worse breathlessness.

    Baseline (Day 0), Day 3, Week 2, and Week 4 follow-up.

  • Respiratory Symptom Severity Score (Breathlessness, Cough and Sputum Scale [BCSS])

    Respiratory symptom severity will be assessed using the Breathlessness, Cough and Sputum Scale (BCSS). The BCSS consists of three symptom domains (breathlessness, cough, and sputum), each scored from 0 to 4, giving a total score ranging from 0 to 12. Higher scores indicate greater respiratory symptom severity (worse outcome).

    Baseline (Day 0), Day 3, Week 2, and Week 4 follow-up.

Study Arms (2)

Buteyko Breathing Technique (BBT)

EXPERIMENTAL

Participants in this group will receive Buteyko Breathing Technique (BBT) along with standard medical care. The intervention aims to improve breathing control and respiratory efficiency in patients with pneumonia. The program includes nasal inhalation to promote nasal breathing instead of mouth breathing. Participants will practice reduced breathing volume to avoid hyperventilation and improve gas exchange. Controlled breathing rate will be used to maintain slow and regular breathing patterns. The intervention also includes breath-holding after exhalation to enhance breathing control. Patients will perform relaxed diaphragmatic breathing to reduce accessory muscle use. All exercises will be supervised by a trained physiotherapist to ensure safety and correct technique. Sessions will be conducted twice daily for 20-30 minutes. The intervention will continue for seven days or until hospital discharge.

Other: Buteyko Breathing Technique (BBT)

Incentive Spirometry (IS)

ACTIVE COMPARATOR

Participants in this group will perform breathing exercises using an incentive spirometer along with standard medical care. The intervention aims to improve lung expansion and respiratory function in patients with pneumonia. Participants will perform slow maximal inhalation using the spirometer to encourage deep breathing and increase lung capacity. Each inhalation will be followed by breath holding for approximately 2-3 seconds to promote better air distribution in the lungs. After this, participants will perform controlled and slow exhalation. The exercise will be repeated several times to support lung expansion and airway clearance. The sessions will be conducted twice daily for 20-30 minutes, and participants will also perform 10 deep breaths every hour while awake. The intervention will continue for seven days or until hospital discharge.

Device: Incentive Spirometry (IS)

Interventions

Buteyko Breathing Technique involves controlled nasal breathing with breath-holding and relaxed exhalation. Participants perform slow nasal inhalation followed by relaxed exhalation at a rate of approximately 6 deep breaths per 30 seconds. Strategic breath-holds after exhalation are incorporated to reduce hyperventilation and increase physiological CO₂ levels. Sessions are supervised twice daily for 20-30 minutes over 7 days or until hospital discharge. Intensity is maintained within patient comfort limits. SpO₂ and Borg dyspnoea scores are monitored during sessions. Sputum volume is recorded post-session. Daily sputum diary is maintained. The goal is to improve breath control, reduce dyspnoea, and facilitate sputum clearance.

Buteyko Breathing Technique (BBT)

This intervention uses an Incentive Spirometry device to promote deep lung inflation. Participants perform slow maximal inhalation to achieve target volume, followed by a 2-3 second breath hold, then slow exhalation. Sessions are supervised twice daily for 20-30 minutes, plus 10 deep breaths per hour while awake, over 7 days or until hospital discharge. Intensity is maintained at gentle maximal inhalation without discomfort. SpO₂ and Borg dyspnoea scores are monitored during sessions. Sputum volume is recorded post-session. Daily sputum diary is maintained. The goal is to improve lung expansion, oxygenation, and inspiratory capacity.

Incentive Spirometry (IS)

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male and female participants Age between 25-40 years Clinically diagnosed pneumonia Recent exposure to high air pollution levels (AQI threshold exceeded within the past 7 days) Resting oxygen saturation between 86-95% Ability to understand and perform breathing exercises -

You may not qualify if:

  • Requirement for mechanical ventilation or ICU admission Hemodynamic instability Severe chronic respiratory disease such as COPD with hypercapnia Pneumothorax or massive hemoptysis Recent thoracic surgery or trauma Cognitive impairment affecting cooperation Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Combined Military Hospital (CMH)

Lahore, Punjab Province, Pakistan

RECRUITING

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2026

First Posted

August 12, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

August 15, 2026

Study Completion (Estimated)

October 15, 2026

Last Updated

August 12, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations