Ignite Creation Date:
2025-12-24 @ 12:30 PM
Ignite Modification Date:
2026-01-31 @ 7:42 AM
Study NCT ID:
NCT02441361
Status:
UNKNOWN
Last Update Posted:
2015-05-12
First Post:
2015-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Exercise Training in Bariatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-05-07', 'studyFirstSubmitDate': '2015-03-31', 'studyFirstSubmitQcDate': '2015-05-07', 'lastUpdatePostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'insulin sensitivity as assessed by surrogates of insulin sensitivity', 'timeFrame': '6 months'}, {'measure': 'body composition as assessed by densitometry (DEXA)', 'timeFrame': '6 months', 'description': 'bone mass, lean mass and fat mass'}, {'measure': 'profile of cytokines', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'physical activity level as assessed by accelerometry', 'timeFrame': '6 months'}, {'measure': 'quality of life as assessed by questionnaires (composite)', 'timeFrame': '6 months'}, {'measure': 'muscle function as assessed by a battery of tests', 'timeFrame': '6 months', 'description': 'timed-stands test, timed-up-ang-go test, maximal strength tests'}, {'measure': 'risk of cardiovascular events as assessed by questionnaires (composite)', 'timeFrame': '6 months'}, {'measure': 'aerobic conditioning as assessed by a cardiopulmonary test.', 'timeFrame': '6 months'}, {'measure': 'depression and anxiety as assessed by questionnaires (composite)', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '36585494', 'type': 'DERIVED', 'citation': 'Merege-Filho CAA, Gil SS, Kirwan JP, Murai IH, Dantas WS, Nucci MP, Pastorello B, de Lima AP, Bazan PR, Pereira RMR, de Sa-Pinto AL, Lima FR, Brucki SMD, de Cleva R, Santo MA, Leite CDC, Otaduy MCG, Roschel H, Gualano B. Exercise modifies hypothalamic connectivity and brain functional networks in women after bariatric surgery: a randomized clinical trial. Int J Obes (Lond). 2023 Mar;47(3):165-174. doi: 10.1038/s41366-022-01251-8. Epub 2022 Dec 30.'}, {'pmid': '34666419', 'type': 'DERIVED', 'citation': 'Gil S, Kirwan JP, Murai IH, Dantas WS, Merege-Filho CAA, Ghosh S, Shinjo SK, Pereira RMR, Teodoro WR, Felau SM, Benatti FB, de Sa-Pinto AL, Lima F, de Cleva R, Santo MA, Gualano B, Roschel H. A randomized clinical trial on the effects of exercise on muscle remodelling following bariatric surgery. J Cachexia Sarcopenia Muscle. 2021 Dec;12(6):1440-1455. doi: 10.1002/jcsm.12815. Epub 2021 Oct 19.'}, {'pmid': '32409493', 'type': 'DERIVED', 'citation': 'Dantas WS, Roschel H, Murai IH, Gil S, Davuluri G, Axelrod CL, Ghosh S, Newman SS, Zhang H, Shinjo SK, das Neves W, Merege-Filho C, Teodoro WR, Capelozzi VL, Pereira RM, Benatti FB, de Sa-Pinto AL, de Cleva R, Santo MA, Kirwan JP, Gualano B. Exercise-Induced Increases in Insulin Sensitivity After Bariatric Surgery Are Mediated By Muscle Extracellular Matrix Remodeling. Diabetes. 2020 Aug;69(8):1675-1691. doi: 10.2337/db19-1180. Epub 2020 May 14.'}, {'pmid': '31322672', 'type': 'DERIVED', 'citation': 'Murai IH, Roschel H, Dantas WS, Gil S, Merege-Filho C, de Cleva R, de Sa-Pinto AL, Lima F, Santo MA, Benatti FB, Kirwan JP, Pereira RM, Gualano B. Exercise Mitigates Bone Loss in Women With Severe Obesity After Roux-en-Y Gastric Bypass: A Randomized Controlled Trial. J Clin Endocrinol Metab. 2019 Oct 1;104(10):4639-4650. doi: 10.1210/jc.2019-00074.'}]}, 'descriptionModule': {'briefSummary': 'Bariatric surgery may attenuate insulin resistance and low-grade inflammation in obese subjects. This trial aims to test whether exercise training can add to the benefits of bariatric surgery on insulin sensitivity and inflammation. In addition, this study aims to investigate whether exercise training can counteract bone loss induced by bariatric surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* body mass index ≥ 35 kg/m2\n* not engaged in physical activity programs\n* without any physical limitation that could preclude exercise participation\n\nExclusion Criteria:\n\n* body mass index \\< 35 kg/m2\n* regular participation in physical activities programs\n* cancer or any other disease that could limit participation in exercise'}, 'identificationModule': {'nctId': 'NCT02441361', 'briefTitle': 'Effects of Exercise Training in Bariatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Effects of Exercise in Bariatric Patients: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Exercise & Bariatric'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'Subjects will undergo bariatric surgery and no exercise training will be prescribed.'}, {'type': 'EXPERIMENTAL', 'label': 'exercise training', 'description': 'Subjects will undergo bariatric surgery and exercise training will be prescribed.', 'interventionNames': ['Other: Exercise training']}], 'interventions': [{'name': 'Exercise training', 'type': 'OTHER', 'description': 'Exercise training will comprise aerobic and strength exercises', 'armGroupLabels': ['exercise training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05508-030', 'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Igor Murai, master', 'role': 'CONTACT', 'email': 'gualano@usp.br', 'phone': '551130918783'}, {'name': 'Bruno Gualano, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Bruno Gualano', 'investigatorAffiliation': 'University of Sao Paulo'}}}}