Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-02-20 @ 1:12 AM
Study NCT ID:
NCT02065258
Status:
UNKNOWN
Last Update Posted:
2014-02-17
First Post:
2014-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Breathing Versus Aerobic Exercises on Asthma Control
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001945', 'term': 'Breathing Exercises'}, {'id': 'D015013', 'term': 'Yoga'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-02-14', 'studyFirstSubmitDate': '2014-02-03', 'studyFirstSubmitQcDate': '2014-02-14', 'lastUpdatePostDateStruct': {'date': '2014-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from Thoracoabdominal kinematics', 'timeFrame': 'After 3 months of intervention', 'description': 'Thoracoabdominal kinematics will be evaluated by using optoelectronic plethysmography (OEP system, BTS, Italy) as previously described Aliverti et al, 2006.'}, {'measure': 'Change from Heart rate variability', 'timeFrame': 'After 3 months of interventions', 'description': 'Heart rate variability will be assessed using heart rate variability (HRV) by a hert rate monitor ( Polar S810i, Finland) previously validated (Gamelin, Berthoin \\& Bosquet, 2006).'}, {'measure': 'Change from Airway and systemic inflammation', 'timeFrame': 'After 3 months of interventions', 'description': 'Airway inflammation will be quantified using the induced sputum , exhaled fraction of nitric oxide . Systemic inflammation will be evaluated by level of plasmatic inflammatory mediators Th1 ( IL-6, TNF) , Th2 (IL-4, IL-5 and IL-13) and anti-inflammatory ( IL-10 and IL-1ra)'}], 'primaryOutcomes': [{'measure': 'Change from Clinical Control', 'timeFrame': 'After 3 months of intervetion', 'description': 'Clinical control will be evaluated by Asthma Control Questionnaire (ACQ)'}], 'secondaryOutcomes': [{'measure': 'Change from psychosocial morbidity', 'timeFrame': 'After 3 months of intervetion', 'description': 'The psychosocial morbidity will be quantified by health factors related to quality of life (Asthma quality of life questionnaire- AQLQ) and depression and anxiety levels (HAD score)'}, {'measure': 'Change from Daily life physical activity (DLPA)', 'timeFrame': 'After 3 months of intervetion', 'description': 'Daily life physical activity will be assessed using an accelerometer (power Walker SW 610, Japan) that records the total daily number of steps and those performed at moderate intensity ( \\>110 steps per minute)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Asthma, Clinical control, Exercise'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '32773365', 'type': 'DERIVED', 'citation': 'Evaristo KB, Mendes FAR, Saccomani MG, Cukier A, Carvalho-Pinto RM, Rodrigues MR, Santaella DF, Saraiva-Romanholo BM, Martins MA, Carvalho CRF. Effects of Aerobic Training Versus Breathing Exercises on Asthma Control: A Randomized Trial. J Allergy Clin Immunol Pract. 2020 Oct;8(9):2989-2996.e4. doi: 10.1016/j.jaip.2020.06.042. Epub 2020 Aug 6.'}, {'pmid': '25326140', 'type': 'DERIVED', 'citation': 'Evaristo KB, Saccomani MG, Martins MA, Cukier A, Stelmach R, Rodrigues MR, Santaella DF, Carvalho CR. Comparison between breathing and aerobic exercise on clinical control in patients with moderate-to-severe asthma: protocol of a randomized trial. BMC Pulm Med. 2014 Oct 17;14:160. doi: 10.1186/1471-2466-14-160.'}]}, 'descriptionModule': {'briefSummary': 'Background: Asthma is a chronic inflammatory airway disease characterized by reversible obstruction, inflammation and hyperresponsiveness to different stimulus. Aerobic and breathing exercises have been demonstrated to benefit asthmatic patients; however, there is no evidence comparing the effectiveness of the treatments. Objective: To compare the effects of aerobic and breathing exercises on clinical control (primary outcome), psychosocial morbidity and daily life physical activity (secondary outcome) in patients with moderate-to-severe persistent asthma. In addition, thoracoabdominal kinematics, heart rate variability and airway and systemic inflammation will be evaluated. The initial hypothesis will be that both exercises present improved clinical control of asthma. Methods: Forty-eight asthmatic adults will be randomly divided into 2 groups: aerobic (AG) and breathing exercises (BG). All treatments will be performed twice a week for 3 months, totalizing 24 sessions of 40 minutes each. Both groups will complete an educational program consisting of 2 classes at the beginning of the interventions. Before and after interventions, the following parameters will be quantified: clinical control, health related quality of life, levels of anxiety and depression, maximal exercise capacity, autonomic nervous imbalance, daily living physical activity, thoracoabdominal kinematics, inflammatory cells in the sputum, fraction of exhaled nitric oxide (FENO) and systemic inflammatory cytokines. Asthma symptoms will be quantified monthly using diaries. Kolmogorov-Smirnov test will be used to analyze the data normality, and a two-way ANOVA with repeated measures with appropriate post hoc test (Student Newman Keuls) will be used to compare the inter and intra-groups differences', 'detailedDescription': 'Both groups completed an educational program that consisted of two classes held once a week, each lasting 2 hours. Presentations and group discussions were done, including information about asthma pathophysiology, medication skills, self-monitoring techniques, and environmental control and avoidance strategies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Asthma moderate and severe\n* Asthma will diagnosed (Global Initiative for Asthma -GINA)\n* Body Mass Index \\<35 kg/ m2\n* Sedentary\n* Medical treatment, for at least 6 months\n* Clinically stable\n\nExclusion Criteria:\n\n* Smokers\n* Cardiac disease\n* Chronic Obstructive Pulmonary Disease\n* Active Cancer\n* Pregnant'}, 'identificationModule': {'nctId': 'NCT02065258', 'briefTitle': 'Breathing Versus Aerobic Exercises on Asthma Control', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Comparison Between Breathing and Aerobic Exercises on Clinical Control, Psychosocial Morbidity, Thoracoabdominal Kinematics, and Airway Inflammation in Patients With Moderate-to-severe Asthma: a Randomized Trial', 'orgStudyIdInfo': {'id': 'Breathing vs. aerobic exercise'}, 'secondaryIdInfos': [{'id': '2009538179', 'type': 'OTHER_GRANT', 'domain': 'São Paulo Research Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Breathing Exercise', 'description': 'It will be based on Yoga´s breathing technique (Eliade, 1996) and will be focus on to stimulate nasal and diaphragmatic breathings, to increase expiratory time, to slow respiratory flow and to regulate the breathing rhythm. Breathing exercises will be divided into 3 phases (lasting one month each) with progressive intensity every 8 sessions and will be part of the routine of breathing exercises the following exercises: I) Kapalabhati ; II) Uddhiyana ;III) Surya Bedhana', 'interventionNames': ['Other: Breathing exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aerobic Exercise', 'description': "Exercise will be performed on a treadmill, with the initial intensity of 60% of the maximum predicted heart rate for patient´s age (Tanaka et al, 2001) reaching a maximal of 80% during the training. The intensity values will be calculated using Karvonen's formule (1957).Aerobic training sessions that will consist in 40 minutes divided in 5 minutes of warm-up, 35 minutes of aerobic training and 5 minutes of cool down. Exercise intensity will be increased if the patient do not present any increase in asthma symptoms during the exercise for 2 consecutive training days. The program will be performed twice a week, for 3 months.", 'interventionNames': ['Other: Aerobic exercise']}], 'interventions': [{'name': 'Breathing exercise', 'type': 'OTHER', 'otherNames': ['Yoga'], 'description': 'It will be based on Yoga´s breathing technique (Eliade, 1996) and will be focus on to stimulate nasal and diaphragmatic breathings, to increase expiratory time, to slow respiratory flow and to regulate the breathing rhythm. Breathing exercises will be divided into 3 phases (lasting one month each) with progressive intensity every 8 sessions.\n\nAll participants will be required to maintain their normal medical regimens during the interventions. Will be part of the routine of breathing exercises the following exercises: I) Kapalabhati, II) Uddhiyana', 'armGroupLabels': ['Breathing Exercise']}, {'name': 'Aerobic exercise', 'type': 'OTHER', 'otherNames': ['Aerobic training'], 'description': "Exercise will be performed on a treadmill (Imbramed Export Plus, Brazil) with the initial intensity of 60% of the maximum predicted heart rate for patient´s age (Tanaka et al, 2001) reaching a maximal of 80% during the training. The intensity values will be calculated using Karvonen's formule (1957). Exercise intensity will be increased if the patient do not present any increase in asthma symptoms during the exercise for 2 consecutive training days. Before and after every session, patients will perform a peak expiratory flow test and if values were lower than 70% of the patient´s maximum value, they will be advised to use the rescue dose of bronchodilator prescribed the their physician", 'armGroupLabels': ['Aerobic Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05360-160', 'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Celso RF Carvalho, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Milene G Saccomani, Msc', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Karen B Evaristo', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Milton A Martins, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Rafael Stelmach, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alberto Cukier, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Regina M Carvalho-Pinto, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marcos Rojo, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Danilo F Santaella, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Beatriz M Saraiva-Romanholo, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Denise Paisani, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital das Clínicas da FMUSP', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Celso Carvalho, PhD', 'role': 'CONTACT', 'email': 'cscarval@usp.br', 'phone': '+55 11 30697451'}], 'overallOfficials': [{'name': 'Celso RF Carvalho, PT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Sao Paulo', 'class': 'OTHER'}, {'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}