Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2026-03-06 @ 4:06 PM
Study NCT ID:
NCT02371733
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2015-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aerobic Exercise Training in Pulmonary Arterial Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}], 'ancestors': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-13', 'studyFirstSubmitDate': '2015-02-20', 'studyFirstSubmitQcDate': '2015-02-20', 'lastUpdatePostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional exercise capacity (Oxygen consumption measurement during test)', 'timeFrame': '6 weeks', 'description': 'Six minute walk test (6MWT)'}], 'secondaryOutcomes': [{'measure': 'Maximum inspiratory and expiratory muscle strength (MIP, MEP)', 'timeFrame': '6 weeks', 'description': 'Mouth pressure device'}, {'measure': 'Peripheral muscle strength', 'timeFrame': '6 weeks', 'description': 'Hand held dynamometer'}, {'measure': 'Pulmonary functions', 'timeFrame': '6 week', 'description': 'Spirometry'}, {'measure': 'Physical activity', 'timeFrame': '6 weeks', 'description': 'Activity monitor'}, {'measure': 'Dyspnea', 'timeFrame': '6 weeks', 'description': 'Modified Borg and Modified Medical Research Council (MMRC) dyspnea scales'}, {'measure': 'Fatigue', 'timeFrame': '6 weeks', 'description': 'Fatigue Severity Scale (FSS)'}, {'measure': 'Generic quality of life', 'timeFrame': '6 weeks', 'description': 'Short Form (SF-36) Health Survey'}, {'measure': 'Depression', 'timeFrame': '6 weeks', 'description': 'Montgomery Asberg Depression Rating Scale (MADRS) (Turkish versions of all scales)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pulmonary arterial hypertension', 'aerobic exercise training', 'upper extremity', 'exercise capacity'], 'conditions': ['Pulmonary Arterial Hypertension']}, 'referencesModule': {'references': [{'pmid': '3109813', 'type': 'RESULT', 'citation': "D'Alonzo GE, Gianotti LA, Pohil RL, Reagle RR, DuRee SL, Fuentes F, Dantzker DR. Comparison of progressive exercise performance of normal subjects and patients with primary pulmonary hypertension. Chest. 1987 Jul;92(1):57-62. doi: 10.1378/chest.92.1.57."}, {'pmid': '10933371', 'type': 'RESULT', 'citation': 'Riley MS, Porszasz J, Engelen MP, Shapiro SM, Brundage BH, Wasserman K. Responses to constant work rate bicycle ergometry exercise in primary pulmonary hypertension: the effect of inhaled nitric oxide. J Am Coll Cardiol. 2000 Aug;36(2):547-56. doi: 10.1016/s0735-1097(00)00727-0.'}, {'pmid': '15176691', 'type': 'RESULT', 'citation': 'Deboeck G, Niset G, Lamotte M, Vachiery JL, Naeije R. Exercise testing in pulmonary arterial hypertension and in chronic heart failure. Eur Respir J. 2004 May;23(5):747-51. doi: 10.1183/09031936.04.00111904.'}, {'pmid': '16982941', 'type': 'RESULT', 'citation': 'Mereles D, Ehlken N, Kreuscher S, Ghofrani S, Hoeper MM, Halank M, Meyer FJ, Karger G, Buss J, Juenger J, Holzapfel N, Opitz C, Winkler J, Herth FF, Wilkens H, Katus HA, Olschewski H, Grunig E. Exercise and respiratory training improve exercise capacity and quality of life in patients with severe chronic pulmonary hypertension. Circulation. 2006 Oct 3;114(14):1482-9. doi: 10.1161/CIRCULATIONAHA.106.618397. Epub 2006 Sep 18.'}, {'pmid': '22452973', 'type': 'RESULT', 'citation': 'McKeough ZJ, Bye PT, Alison JA. Arm exercise training in chronic obstructive pulmonary disease: a randomised controlled trial. Chron Respir Dis. 2012 Aug;9(3):153-62. doi: 10.1177/1479972312440814. Epub 2012 Mar 27.'}, {'pmid': '17474643', 'type': 'RESULT', 'citation': 'Nyquist-Battie C, Fletcher GF, Fletcher B, Carlson JM, Castello R, Oken K. Upper-extremity exercise training in heart failure. J Cardiopulm Rehabil Prev. 2007 Jan-Feb;27(1):42-5. doi: 10.1097/01.hcr.0000265019.18661.82.'}, {'pmid': '32457004', 'type': 'DERIVED', 'citation': 'Yilmaz BC, Guclu MB, Keles MN, Tacoy GA, Cengel A. Effects of upper extremity aerobic exercise training on oxygen consumption, exercise capacity, dyspnea and quality of life in patients with pulmonary arterial hypertension. Heart Lung. 2020 Sep-Oct;49(5):564-571. doi: 10.1016/j.hrtlng.2020.04.006. Epub 2020 May 24.'}]}, 'descriptionModule': {'briefSummary': 'Decreased exercise capacity, peripheral muscle strength and quality of life and increased dyspnea and fatigue perception is prevalent in patients with pulmonary arterial hypertension. It was demonstrated exercise training has beneficial effects in patients with pulmonary arterial hypertension. However, no study investigated the effects of upper extremity aerobic exercise training, therefore effects of upper extremity aerobic exercise training on outcomes in patients with pulmonary arterial hypertension.', 'detailedDescription': 'Patients were diagnosed with pulmonary arterial hypertension according to the Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of f the European Society of Cardiology (ESC) and European Respiratory Society (ERS). Primary outcome measurement was exercise capacity, secondary outcomes were respiratory and peripheral muscle strength, physical activity, quality of life, fatigue, dyspnea and depression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinically stable\n* Under standard medication\n* Group 1 pulmonary arterial hypertension patients\n* Having no exacerbation or infection\n\nExclusion Criteria:\n\n* Cognitive disorders\n* Orthopedic and neurological problems\n* Pneumonia or acute infection\n* Stage 4 heart failure\n* Having no comorbidity to avoid performing evaluation and training'}, 'identificationModule': {'nctId': 'NCT02371733', 'briefTitle': 'Aerobic Exercise Training in Pulmonary Arterial Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Gazi University'}, 'officialTitle': 'Effects of Upper Extremity Aerobic Exercise Training on Functional Exercise Capacity in Patients With Pulmonary Arterial Hypertension', 'orgStudyIdInfo': {'id': 'Gazi University2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Training Group', 'description': 'Intervention:Training group will receive upper extremity aerobic exercise training using arm ergometer and breathing exercises.', 'interventionNames': ['Other: Upper extremity aerobic exercise training']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control Group', 'description': 'Sham: Control group will receive alternative upper extremity exercises and breathing exercises.', 'interventionNames': ['Other: Alternative upper extremity exercises']}], 'interventions': [{'name': 'Upper extremity aerobic exercise training', 'type': 'OTHER', 'description': 'Training group will receive upper extremity aerobic exercise training using arm ergometer at 50-80% of maximal heart rate and breathing exercises.\n\nTraining will exercise with arm ergometer 3days/week, for 6 weeks with the assistance of a physiotherapist. Training workload will be undercontrol both using target heart rate and Modified Borg dyspnea scale. Training group will also perform breathing exercises 120 times/day, 7 days/week, for 6 weeks.', 'armGroupLabels': ['Training Group']}, {'name': 'Alternative upper extremity exercises', 'type': 'OTHER', 'description': 'Control group will receive alternative upper extremity exercises and breathing exercises. Control group will perform alternative upper extremity exercises 3days/week, for 6 weeks and also breathing exercises 120 times/day, 7 days/week, for 6 weeks.\n\nControl group will be followed-up by telephone once a week.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06500', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Gazi University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Burcu Camcıoğlu, MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Gazi University'}, {'name': 'Meral Boşnak Güçlü, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gazi University'}, {'name': 'Müşerrefe N Karadallı, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gazi University'}, {'name': 'Gülten Aydoğdu Taçoy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gazi University'}, {'name': 'Atiye Çengel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gazi University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gazi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof', 'investigatorFullName': 'Meral Boşnak Güçlü', 'investigatorAffiliation': 'Gazi University'}}}}