Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2026-03-26 @ 3:49 PM
Study NCT ID:
NCT03075332
Status:
COMPLETED
Last Update Posted:
2017-03-09
First Post:
2017-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detraining in People Living With HIV/AIDS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D039682', 'term': 'HIV-Associated Lipodystrophy Syndrome'}, {'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D008060', 'term': 'Lipodystrophy'}, {'id': 'D012875', 'term': 'Skin Diseases, Metabolic'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'This is a longitudinal study of the non-randomized experimental type, presenting a non-probabilistic sample for convenience and independent groups. The sample consisted of 21 individuals divided into 2 groups: Experimental Group (EG) and Control Group (CG). The EG was composed of 11 people living with HIV/AIDS and CG composed of 10 people with no infection'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-07-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-08', 'studyFirstSubmitDate': '2017-02-09', 'studyFirstSubmitQcDate': '2017-03-08', 'lastUpdatePostDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'body composition', 'timeFrame': '21 weeks', 'description': 'kg (body composition was evaluated through the DXA)'}], 'primaryOutcomes': [{'measure': 'Capacity cardiorespiratory', 'timeFrame': '21 weeks', 'description': 'ml (cardiorespiratory aptitude through the ergometer)'}], 'secondaryOutcomes': [{'measure': 'test force', 'timeFrame': '21 weeks', 'description': 'kg (strength of the upper and lower limbs through dynamometry)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Detraining', 'Physical aptitude', 'HIV'], 'conditions': ['Lipodystrophy Syndrome, HIV', 'Sarcopenia']}, 'referencesModule': {'availIpds': [{'id': 'plataforma brasil', 'url': 'http://aplicacao.saude.gov.br/plataformabrasil/visao/pesquisador/gerirPesquisa/gerirPesquisaAgrupador.jsf', 'type': 'Ethics committee project', 'comment': 'all project'}], 'references': [{'pmid': '28135804', 'type': 'BACKGROUND', 'citation': 'Warshaw MG, Carey VJ, McFarland EJ, Dawson L, Abrams E, Melvin A, Fairlie L, Spiegel H, Jay J, Agwu AL; IMPAACT P1094 Team. The interaction between equipoise and logistics in clinical trials: A case study. Clin Trials. 2017 Jun;14(3):314-318. doi: 10.1177/1740774517690734. Epub 2017 Jan 31.'}, {'pmid': '28074681', 'type': 'BACKGROUND', 'citation': "Li A, McCabe T, Silverstein E, Dragan S, Salbach NM, Zobeiry M, Beldick S, Godi C, O'Brien KK. Community-Based Exercise in the Context of HIV: Factors to Consider when Developing and Implementing Community-Based Exercise Programs for People Living with HIV. J Int Assoc Provid AIDS Care. 2017 May/Jun;16(3):267-275. doi: 10.1177/2325957416686836. Epub 2017 Jan 11."}, {'pmid': '26378794', 'type': 'BACKGROUND', 'citation': 'Gomes Neto M, Conceicao CS, Oliveira Carvalho V, Brites C. Effects of Combined Aerobic and Resistance Exercise on Exercise Capacity, Muscle Strength and Quality of Life in HIV-Infected Patients: A Systematic Review and Meta-Analysis. PLoS One. 2015 Sep 17;10(9):e0138066. doi: 10.1371/journal.pone.0138066. eCollection 2015.'}, {'pmid': '28001474', 'type': 'BACKGROUND', 'citation': 'Poton R, Polito M, Farinatti P. Effects of resistance training in HIV-infected patients: A meta-analysis of randomised controlled trials. J Sports Sci. 2017 Dec;35(24):2380-2389. doi: 10.1080/02640414.2016.1267389. Epub 2016 Dec 21.'}, {'pmid': '27724840', 'type': 'BACKGROUND', 'citation': 'Chitu-Tisu CE, Barbu EC, Lazar M, Bojinca M, Tudor AM, Hristea A, Abagiu AO, Ion DA, Badarau AI. Body composition in HIV-infected patients receiving highly active antiretroviral therapy. Acta Clin Belg. 2017 Feb;72(1):55-62. doi: 10.1080/17843286.2016.1240426. Epub 2016 Oct 11.'}, {'pmid': '34630129', 'type': 'DERIVED', 'citation': 'Araujo JS, de Medeiros RCDSC, da Silva TAL, de Medeiros DC, de Medeiros JA, Dos Santos IK, Wilde P, Cabral BGAT, Medeiros RMV, Dantas PMS. Effect of Training and Detraining in the Components of Physical Fitness in People Living With HIV/AIDS. Front Physiol. 2021 Sep 22;12:586753. doi: 10.3389/fphys.2021.586753. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study was to evaluate the effect of detraining in the components of physical aptitude of people living with HIV/Aids (PVHA).', 'detailedDescription': 'The study was experimental with a sample composed by an Experimental Group (EG) with 11 PVHA, under antiretroviral therapy and a Control Group (CG) with 10 individuals without the infection; all which were under medical release and insufficiently active. The body composition was evaluated through the DXA, as well as the cardiorespiratory aptitude through the ergometer and the strength of the upper and lower limbs through dynamometry. Both groups conducted interventions with concurrent training for 15 weeks and the interruption of exercise was evaluated after a period of 5 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Group experience to have a diagnosis of at least 2 years living with HIV / AIDS being in clinical follow-up in the Specialized Attention Services in HIV / AIDS (SAE), using ART, TCD4 lymphocyte count equal to or greater than 500 copies / mm³, viral load Undetectable (≤ 50 copies / mm³)\n* Group control without any diagnosis of HIV / AIDS or any other pathology. Both groups completed the exercise program with a minimum frequency of 75%.\n\nExclusion Criteria:\n\n* Both groups taking part in any physical exercise in time of detraining'}, 'identificationModule': {'nctId': 'NCT03075332', 'acronym': 'PVHA', 'briefTitle': 'Detraining in People Living With HIV/AIDS', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal do Rio Grande do Norte'}, 'officialTitle': 'Detraining in the Components of Physical Aptitude in People Living With HIV/ AIDS', 'orgStudyIdInfo': {'id': 'VIVER MAIS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'protocol with physical exercise', 'description': 'Both groups underwent a combined training intervention consisting of aerobic and resisted exercises in the same training session', 'interventionNames': ['Other: combined training']}], 'interventions': [{'name': 'combined training', 'type': 'OTHER', 'description': 'Combined training consisting of aerobic and resisted training in the same training session for 15 weeks followed by 5 weeks of detraining', 'armGroupLabels': ['protocol with physical exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59152600', 'city': 'Natal', 'state': 'Rio Grande do Norte', 'country': 'Brazil', 'facility': 'Juliany de Souza Araujo', 'geoPoint': {'lat': -5.795, 'lon': -35.20944}}, {'zip': '59152600', 'city': 'Parnamirim', 'state': 'Rio Grande do Norte', 'country': 'Brazil', 'facility': 'Juliany de Souza Araujo', 'geoPoint': {'lat': -5.91556, 'lon': -35.26278}}], 'overallOfficials': [{'name': 'juliany araujo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade Federal do Rio Grande do Norte'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'It is not done sharing since the individuals involved in the people are vulnerable and the secrecy is rescued'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal do Rio Grande do Norte', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'JULIANY DE SOUZA ARAUJO', 'investigatorAffiliation': 'Universidade Federal do Rio Grande do Norte'}}}}