Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2026-02-23 @ 2:50 AM
Study NCT ID:
NCT07140458
Status:
COMPLETED
Last Update Posted:
2025-08-24
First Post:
2025-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Effect of Box Breathing And Buteyko Breathing on Pulmonary Functions in Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-18', 'studyFirstSubmitDate': '2025-07-14', 'studyFirstSubmitQcDate': '2025-08-18', 'lastUpdatePostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lung Function tests (FVC)', 'timeFrame': 'through study completion, approximately 8 weeks', 'description': 'Changes from Baseline, Lung function tests measure how well the lungs take in, hold, and move air, as well as how efficiently they transfer oxygen into the blood. These tests help diagnose and monitor respiratory diseases like asthma, COPD, pulmonary fibrosis, and restrictive lung diseases. Tets measures are compared against Normal value i.e: FVC ≥80%.'}, {'measure': 'Lung Function Test (FEV¹)', 'timeFrame': 'through study completion, approximately 8 weeks', 'description': 'Changes from Baseline, Lung function tests measure how well the lungs take in, hold, and move air, as well as how efficiently they transfer oxygen into the blood. These tests help diagnose and monitor respiratory diseases like asthma, COPD, pulmonary fibrosis, and restrictive lung diseases. Test measures are compared against Normal value i.e: FEV¹ ≥80%.'}, {'measure': 'Lung Function test (FEV₁/FVC ratio)', 'timeFrame': 'through study completion, approximately 8 weeks', 'description': 'Changes from Baseline, Lung function tests measure how well the lungs take in, hold, and move air, as well as how efficiently they transfer oxygen into the blood. These tests help diagnose and monitor respiratory diseases like asthma, COPD, pulmonary fibrosis, and restrictive lung diseases. Test measures are compared against Normal value i.e: FEV₁/FVC ≥0.7.'}], 'secondaryOutcomes': [{'measure': 'Modified Borg Dyspnea Scale', 'timeFrame': 'through study completion, approximately 8 weeks', 'description': "The Modified Borg Dyspnea Scale (MBS) is a subjective tool used to measure a patient's perceived breathlessness (dyspnea) during physical activity or at rest.\n\nScoring System:\n\n-Scale Range: 0 to 10(with verbal descriptors for each level). Higher values signify worse condition (Maximal effort)."}, {'measure': 'Mcgill quality of life questionnaire', 'timeFrame': 'through study completion, approximately 8 weeks', 'description': 'The MQOL is a validated tool designed to assess the quality of life (QoL) in patients with life-threatening or chronic illnesses. It focuses on \\*physical, psychological, existential, and social well-being\\*.\n\nResponse Scale: Most items use a 0-10 numerical rating scale (higher = better QoL).\n\n* 0 = Worst possible experience\n* 10= Best possible experience Overall Higher scores indicate better quality of life. Whereas Lower scores suggest significant distress in a domain (e.g., pain, existential crisis).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Asthma', 'Breathing Exercise', 'Buteyko Breathing', 'Box Breathing', 'Pulmonary Function tests'], 'conditions': ['Asthma (Diagnosis)', 'Breathing Exercises']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Satria O, Apriani F, Damayanti S, Muharamah D. Pengaruh Teknik Pernapasan Buteyko Terhadap Penurunan Kekambuhan Asma Pada Pasien Asma Bronkhial. Journal Of Health And Physical. 2025;1(1):1-7.'}, {'type': 'BACKGROUND', 'citation': 'Abd Allah Abd El Hafeez N, Khalil Hafez M, Mohamed ahmed Z, Metwally El-Sayed M, Abdelwahab Khedr M, Fathy ahmed dawood R. Evaluating the Effect of Buteyko Breathing Technique in Enhancing Asthma Control and Life Quality Among Asthma Patients: A Nursing-Led QuasiExperimental Study. Egyptian Journal of Health Care. 2025;16(1):831-52.'}, {'pmid': '40487067', 'type': 'BACKGROUND', 'citation': 'Celik H, Yuruk E. The effect of the Buteyko breathing technique on asthma control and quality of life in children with asthma aged 7-12 years: a randomized controlled study. PeerJ. 2025 Jun 3;13:e19467. doi: 10.7717/peerj.19467. eCollection 2025.'}, {'type': 'BACKGROUND', 'citation': 'Mahmoud Abo El-Fadl N, Mohammed Mahmoud D. Buteyko Breathing Technique versus Pranayama Technique on Asthma Control among Asthmatic Patients. Journal of Nursing Science Benha University. 2024;5(2):728-54'}, {'type': 'BACKGROUND', 'citation': 'Mokkink L, Prinsen C, Patrick D, Alonso J, Bouter L, De Vet H, et al. COSMIN methodology for systematic reviews of Patient-Reported Outcome Measures (PROMs)-User manual (version 1.0). Retrieved from. 2018'}, {'pmid': '22958431', 'type': 'BACKGROUND', 'citation': 'Crisafulli E, Clini EM. Measures of dyspnea in pulmonary rehabilitation. Multidiscip Respir Med. 2010 Jun 30;5(3):202-10. doi: 10.1186/2049-6958-5-3-202.'}, {'type': 'BACKGROUND', 'citation': 'Santoso FM, Harmayetty H, Bakar A, editors. PERBANDINGAN LATIHAN NAPAS BUTEYKO DAN UPPER BODY EXERCISE TERHADAP ARUS PUNCAK EKSPIRASI PADA PASIEN DENGAN ASMA BRONKIAL2014.'}, {'type': 'BACKGROUND', 'citation': 'Udayani W, Amin MF, Makhfudli M. The Effect of Combination of Buteyko Breathing Technique and Walking Exercise on Forced Peak Expiratory Flow In Adult Asthmatic Patients. Jurnal Keperawatan Padjadjaran. 2019'}, {'pmid': '33197659', 'type': 'BACKGROUND', 'citation': 'Vagedes J, Helmert E, Kuderer S, Vagedes K, Wildhaber J, Andrasik F. The Buteyko breathing technique in children with asthma: a randomized controlled pilot study. Complement Ther Med. 2021 Jan;56:102582. doi: 10.1016/j.ctim.2020.102582. Epub 2020 Oct 23.'}, {'type': 'BACKGROUND', 'citation': 'Ahmed A, Gayatri Devi R, Jothi Priya A. Effect of Box Breathing Technique on Lung Function Test. 2021.'}, {'type': 'BACKGROUND', 'citation': 'Mohamed NK, Sayed EH, Abd-Elhamed AG. Comparison between The Effect of Buteyko and Pranayama Breathing Techniques on Children with Asthma. Assiut Scientific Nursing Journal. 2022;10(29):139-51.'}, {'type': 'BACKGROUND', 'citation': 'Yosifine Y, Margaretha M, Fatik R, Saputra R, Naning D, Meiliana R, et al. Intervensi teknik pernafasan Buteyko terhadap penurunan respirasi rate dan saturasi oksigen pada pasien asma bronchial: Intervention of Buteyko breathing technique on reduction of respiratory rate and oxygen saturation in bronchial asthma patients. Open Access Jakarta Journal of Health Sciences. 2022;1(9):318-22'}, {'type': 'BACKGROUND', 'citation': 'Azab A, Moawd S, AbdulRahman R. Effect of buteyko breathing exercises versus yoga training on pulmonary functions and functional capacity in children with bronchial asthma: a randomized controlled trial. International Journal of Therapies and Rehabilitation Research. 2017;6(1):148.'}, {'type': 'BACKGROUND', 'citation': 'David J, Patil H. Immediate effect of Buteyko breathing technique versus stacked breathing technique in asthma patients. International journal of health science and research. 2022;12(6):158'}, {'pmid': '29247426', 'type': 'BACKGROUND', 'citation': 'Sankar J, Das RR. Asthma - A Disease of How We Breathe: Role of Breathing Exercises and Pranayam. Indian J Pediatr. 2018 Oct;85(10):905-910. doi: 10.1007/s12098-017-2519-6. Epub 2017 Dec 16.'}, {'type': 'BACKGROUND', 'citation': 'AbdElmawla Elsaid RA, Zahran WE-k, Elsaid Hafez DM. Comparison of the Effects of Buteyko and Diaphragmatic Breathing Technique on Improving Pulmonary Functions and Asthma Control among Patients with Bro. Egyptian Journal of Nursing and Health Sciences. 2023;4(3):57-75.'}, {'type': 'BACKGROUND', 'citation': 'Hasoon ZK, Abdulwahhab MM. Effectiveness of Buteyko Technique, Pursed-Lip Breathing, and Inhaler Technique Program on Asthma Control for Patients with Asthma. Bahrain Medical Bulletin. 2024;46('}, {'type': 'BACKGROUND', 'citation': 'Kwa E-K, Cheong S-K, Ong L-K, Lee P-F. Comparing Guided and Non-guided Deep Breathing Impact on Disability Well-Being: A Systematic Review. Journal of Medical and Biological Engineering. 2024;44(5):635-54.'}, {'pmid': '22336677', 'type': 'BACKGROUND', 'citation': "Parshall MB, Schwartzstein RM, Adams L, Banzett RB, Manning HL, Bourbeau J, Calverley PM, Gift AG, Harver A, Lareau SC, Mahler DA, Meek PM, O'Donnell DE; American Thoracic Society Committee on Dyspnea. An official American Thoracic Society statement: update on the mechanisms, assessment, and management of dyspnea. Am J Respir Crit Care Med. 2012 Feb 15;185(4):435-52. doi: 10.1164/rccm.201111-2042ST."}, {'pmid': '10839848', 'type': 'BACKGROUND', 'citation': 'Kendrick KR, Baxi SC, Smith RM. Usefulness of the modified 0-10 Borg scale in assessing the degree of dyspnea in patients with COPD and asthma. J Emerg Nurs. 2000 Jun;26(3):216-22. doi: 10.1016/s0099-1767(00)90093-x.'}, {'pmid': '36117601', 'type': 'BACKGROUND', 'citation': 'Kharaba Z, Feghali E, El Husseini F, Sacre H, Abou Selwan C, Saadeh S, Hallit S, Jirjees F, AlObaidi H, Salameh P, Malaeb D. An Assessment of Quality of Life in Patients With Asthma Through Physical, Emotional, Social, and Occupational Aspects. A Cross-Sectional Study. Front Public Health. 2022 Sep 1;10:883784. doi: 10.3389/fpubh.2022.883784. eCollection 2022.'}, {'pmid': '17994405', 'type': 'BACKGROUND', 'citation': 'Lisspers K, Stallberg B, Hasselgren M, Johansson G, Svardsudd K. Quality of life and measures of asthma control in primary health care. J Asthma. 2007 Nov;44(9):747-51. doi: 10.1080/02770900701645298.'}, {'pmid': '24199257', 'type': 'BACKGROUND', 'citation': 'Feeny DH, Eckstrom E, Whitlock EP, Perdue LA. A Primer for Systematic Reviewers on the Measurement of Functional Status and Health-Related Quality of Life in Older Adults [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 Sep. Report No.: 13-EHC128-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK169159/'}, {'pmid': '33280709', 'type': 'BACKGROUND', 'citation': 'Expert Panel Working Group of the National Heart, Lung, and Blood Institute (NHLBI) administered and coordinated National Asthma Education and Prevention Program Coordinating Committee (NAEPPCC); Cloutier MM, Baptist AP, Blake KV, Brooks EG, Bryant-Stephens T, DiMango E, Dixon AE, Elward KS, Hartert T, Krishnan JA, Lemanske RF Jr, Ouellette DR, Pace WD, Schatz M, Skolnik NS, Stout JW, Teach SJ, Umscheid CA, Walsh CG. 2020 Focused Updates to the Asthma Management Guidelines: A Report from the National Asthma Education and Prevention Program Coordinating Committee Expert Panel Working Group. 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How Breath-Control Can Change Your Life: A Systematic Review on Psycho-Physiological Correlates of Slow Breathing. Front Hum Neurosci. 2018 Sep 7;12:353. doi: 10.3389/fnhum.2018.00353. eCollection 2018.'}, {'type': 'BACKGROUND', 'citation': 'Arora RD, Subramanian VH. To study the effect of Buteyko breathing technique in patients with obstructive airway disease. International Journal of Health Sciences and Research. 2019;9(3):50-64.'}, {'type': 'BACKGROUND', 'citation': 'Hassan EEM, Abusaad FE, Mohammed BA. Effect of the Buteyko breathing technique on asthma severity control among school age children. The Egyptian Journal of Bronchology. 2022;16(1):45.'}, {'type': 'BACKGROUND', 'citation': 'Villareal GMC, Villazor BPU, Villegas AM, Visaya P, Vista ME, Tan CB, et al. Effect of Buteyko method on asthma control and quality of life of Filipino adults with bronchial asthma. 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Pediatr Ann. 2019 Mar 1;48(3):e121-e127. doi: 10.3928/19382359-20190219-02.'}, {'pmid': '26614594', 'type': 'BACKGROUND', 'citation': 'Aalbers R, Vogelmeier C, Kuna P. Achieving asthma control with ICS/LABA: A review of strategies for asthma management and prevention. Respir Med. 2016 Feb;111:1-7. doi: 10.1016/j.rmed.2015.11.002. Epub 2015 Nov 6.'}, {'type': 'BACKGROUND', 'citation': 'Shafiek H. Inhaled Corticosteroids: Benefits and Risks. Updates on Corticosteroids: IntechOpen; 2023.'}, {'pmid': '23543548', 'type': 'BACKGROUND', 'citation': 'Cates CJ, Jaeschke R, Schmidt S, Ferrer M. Regular treatment with salmeterol and inhaled steroids for chronic asthma: serious adverse events. Cochrane Database Syst Rev. 2013 Mar 28;(3):CD006922. doi: 10.1002/14651858.CD006922.pub3.'}, {'pmid': '37280414', 'type': 'BACKGROUND', 'citation': 'Amirav I, Garcia G, Le BK, Barria P, Levy G, Aggarwal B, Fahrbach K, Martin A, Phansalkar A, Sriprasart T. SABAs as Reliever Medications in Asthma Management: Evidence-Based Science. Adv Ther. 2023 Jul;40(7):2927-2943. doi: 10.1007/s12325-023-02543-9. Epub 2023 Jun 7.'}, {'type': 'BACKGROUND', 'citation': "Colledge NR, Walker BR, Ralston S, Davidson LSP. Davidson's principles and practice of medicine. (No Title). 2014."}, {'type': 'BACKGROUND', 'citation': 'Hassan ZM, Riad NM, Ahmed FH. Effect of Buteyko breathing technique on patients with bronchial asthma. Egyptian Journal of Chest Diseases and Tuberculosis. 2012;61(4):235-41.'}], 'seeAlsoLinks': [{'url': 'https://ginasthma.org/', 'label': 'Global Strategy for Asthma Management and Prevention. \\[Online Web Data\\]. 2023'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to evaluate the Effectiveness of Box Breathing Technique and Buteyko breathing techniques in patients with Asthma, using both Clinical Pulmonary tests as well as Patient reported outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with bronchial asthma for more than one year\n* Subjects who are on regular treatment (both inhalers and medication).\n* Subjects who are conscious and cooperative.\n\nExclusion Criteria:\n\n* Subject with recent abdominal, thoracic surgery.\n* Subject with any Disability; Physical or Mental.\n* Subjects who have other chronic respiratory diseases, new or current smoker, and had respiratory tract infection.'}, 'identificationModule': {'nctId': 'NCT07140458', 'briefTitle': 'Comparative Effect of Box Breathing And Buteyko Breathing on Pulmonary Functions in Asthma', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Comparative Effect of Box Breathing And Buteyko Breathing on Pulmonary Functions in Asthma', 'orgStudyIdInfo': {'id': 'REC/RCR & AHS/24/0325 Ezaz'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Buteyko Breathing', 'description': 'Using Buteyko Breathing as primary intervention in addition to standard Asthma therapy.', 'interventionNames': ['Other: Buteyko Breathing']}, {'type': 'EXPERIMENTAL', 'label': 'Box Breathing Technique', 'description': 'Using Buteyko Breathing as primary intervention in addition to standard Asthma therapy.', 'interventionNames': ['Other: Box breathing']}], 'interventions': [{'name': 'Buteyko Breathing', 'type': 'OTHER', 'description': 'Buteyko Breathing is a technique focusing on controlled, reduced breathing to improve oxygen uptake and reduce hyperventilation-related symptoms using Air hunger.\n\nProcedure:-\n\nAfter gaining proper relaxation:\n\n1. Exhale slowly, and then hold that breath.\n2. Use the index finger and thumb to plug the nose.\n3. Hold that breath until there is an urge to breathe, and then inhale.\n4. Breathe normally for at least 10 seconds.\n5. Repeat several times.', 'armGroupLabels': ['Buteyko Breathing']}, {'name': 'Box breathing', 'type': 'OTHER', 'description': 'Box Breathing (4-4-4-4 Technique) - Box Breathing exercises boosts lung function by optimizing oxygen flow and activating relaxation responses.Each exercise Sessions included 20 cycles of Box Breathing.\n\nThe procedure of the box breathing cycle includes:\n\n1. inhale for 4 seconds\n2. Hold the breath for 4 seconds\n3. Exhale for 4 seconds\n4. Hold the breath for 4 seconds, and repeat.', 'armGroupLabels': ['Box Breathing Technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51310', 'city': 'Sialkot', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Islam center and Teaching Hospital', 'geoPoint': {'lat': 32.49268, 'lon': 74.53134}}], 'overallOfficials': [{'name': 'Qurat ul Ain, Masters', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}