- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07759583
Effects of Buteyko Breathing Versus Incentive Spirometry on Oxygen Saturation, Dyspnoea, Exercise Tolerance, and Sputum Clearance in Patients With Smog Induced Pneumonia
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.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
Smog and air pollution are major environmental health concerns in urban areas and are strongly associated with respiratory diseases, including pneumonia. Exposure to high concentrations of particulate matter and irritant gases can impair pulmonary defense mechanisms, leading to respiratory infections, reduced oxygen saturation, breathlessness, mucus retention, and reduced exercise tolerance .
Physiotherapy plays an important role in pulmonary rehabilitation by improving ventilation, enhancing oxygenation, and facilitating airway clearance. Breathing techniques and respiratory exercises are commonly used supportive therapies to improve respiratory mechanics and promote recovery.
The Buteyko Breathing Technique (BBT) is a breathing retraining method that emphasizes nasal breathing, reduced breathing volume, slow respiratory rate, and breath-holding exercises. The technique aims to normalize breathing patterns and improve oxygen delivery by maintaining optimal carbon dioxide levels in the blood. These physiological changes may improve ventilation efficiency, reduce dyspnoea, and enhance mucociliary clearance .
In contrast, Incentive Spirometry (IS) is a widely used respiratory therapy device that encourages deep inspiration and sustained maximal inhalation. This intervention promotes lung expansion, prevents atelectasis, improves ventilation distribution, and assists in mobilizing pulmonary secretions. Incentive spirometry is frequently used in pulmonary rehabilitation and postoperative respiratory care to improve lung function and oxygenation .
Although both breathing techniques are commonly used in respiratory rehabilitation, there is limited comparative evidence regarding their effectiveness in patients with pneumonia related to environmental pollution such as smog. Most existing research focuses on chronic respiratory diseases such as asthma or COPD.
Therefore, this study aims to compare the effectiveness of Buteyko Breathing Technique and Incentive Spirometry in improving clinical outcomes including oxygen saturation, dyspnoea, exercise tolerance, and sputum clearance in patients with smog-induced pneumonia. The findings may help establish evidence-based physiotherapy protocols for managing respiratory complications associated with air pollution.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Faizan Ahmad
- Puhelinnumero: 03054741978
- Sähköposti: faizanxahmad21@gmail.com
Tutki yhteystietojen varmuuskopiointi
- Nimi: Sahar Fatima
- Puhelinnumero: 03271202200
- Sähköposti: Sahar.fatime@ubas.edu.pk
Opiskelupaikat
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Punjab Province
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Lahore, Punjab Province, Pakistan
- Rekrytointi
- Combined Military Hospital (CMH)
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Ottaa yhteyttä:
- Shoaib Waqas
- Puhelinnumero: 03024552109
- Sähköposti: shoaib.waqas@ubad.edu.pk
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
Inclusion Criteria:
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 -
Exclusion Criteria:
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
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Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: Buteyko Breathing Technique (BBT)
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.
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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.
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Active Comparator: Incentive Spirometry (IS)
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.
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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.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Peripheral Oxygen Saturation (SpO₂)
Aikaikkuna: Baseline (Day 0), Day 3, Week 2, and Week 4 follow-up.
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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%.
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Baseline (Day 0), Day 3, Week 2, and Week 4 follow-up.
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Six-Minute Walk Distance (6MWD)
Aikaikkuna: Baseline (Day 0), Day 3, Week 2, and Week 4 follow-up.
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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.
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Baseline (Day 0), Day 3, Week 2, and Week 4 follow-up.
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Sputum Wet Weight
Aikaikkuna: Baseline (Day 0), Day 3, Week 2, and Week 4 follow-up.
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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.
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Baseline (Day 0), Day 3, Week 2, and Week 4 follow-up.
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Dyspnoea Severity Score (Modified Borg Dyspnoea Scale)
Aikaikkuna: Baseline (Day 0), Day 3, Week 2, and Week 4 follow-up.
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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.
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Baseline (Day 0), Day 3, Week 2, and Week 4 follow-up.
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Respiratory Symptom Severity Score (Breathlessness, Cough and Sputum Scale [BCSS])
Aikaikkuna: Baseline (Day 0), Day 3, Week 2, and Week 4 follow-up.
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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).
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Baseline (Day 0), Day 3, Week 2, and Week 4 follow-up.
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Yhteistyökumppanit ja tutkijat
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
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Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
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