Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT04512456
Status:
RECRUITING
Last Update Posted:
2025-04-30
First Post:
2020-08-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cardiovascular Responses to Exercise in People Living With HIV/AIDS: Effects of Exercise Training
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'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': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, '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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'HIV+active group will perform exercise training, while HIV+inactive and HIV- groups will not undergo intervention.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 63}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-28', 'studyFirstSubmitDate': '2020-08-07', 'studyFirstSubmitQcDate': '2020-08-12', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline Blood Pressure at 3 months', 'timeFrame': 'Baseline and 3 months of follow-up', 'description': 'Blood pressure will be assessed by a digital sphygmomanometer.'}, {'measure': 'Change from Baseline Heart Rate Variability at 3 months', 'timeFrame': 'Baseline and 3 months of follow-up', 'description': 'Heart rate variability will be assessed by a heart rate monitor.'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline Heart Rate at 3 months', 'timeFrame': 'Baseline and 3 months of follow-up', 'description': 'Heart rate will be evaluated beat-to-beat by means of a heart rate monitor.'}, {'measure': 'Change from Baseline Peripheral Vascular Resistance at 3 months', 'timeFrame': 'Baseline and 3 months of follow-up', 'description': 'Peripheral Vascular Resistance will be evaluated by photpletismography.'}, {'measure': 'Change from Baseline Stroke Volume at 3 months', 'timeFrame': 'Baseline and 3 months of follow-up', 'description': 'Stroke Volume will be evaluated by photoplethysmography.'}, {'measure': 'Change from Baseline Cardiac Output at 3 months', 'timeFrame': 'Baseline and 3 months of follow-up', 'description': 'Cardiac Output will be evaluated by photoplethysmography.'}, {'measure': 'Change from Baseline Blood Lactate at 3 months', 'timeFrame': 'Baseline and 3 months of follow-up.', 'description': 'Blood Lactate will be determined by the YSL 2700 analyzer.'}, {'measure': 'Change from Baseline Anthropometric markers at 3 months', 'timeFrame': 'Baseline and 3 months of follow-up.', 'description': 'Anthropometric markers will be determined by a digital scale and wall-mounted stadiometer.'}, {'measure': 'Change from Baseline handgrip maximal voluntary contraction at 3 months', 'timeFrame': 'Baseline and 3 months of follow-up.', 'description': 'Handgrip maximal voluntary contraction will be assessed using a hydraulic handgrip dynamometer.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '35303017', 'type': 'DERIVED', 'citation': 'Gama G, Dos Santos Rangel MV, de Oliveira Coelho VC, Paz GA, de Matos CVB, Silva BP, Lopes GO, Lopes KG, Farinatti P, Borges JP. The effects of exercise training on autonomic and hemodynamic responses to muscle metaboreflex in people living with HIV/AIDS: A randomized clinical trial protocol. PLoS One. 2022 Mar 18;17(3):e0265516. doi: 10.1371/journal.pone.0265516. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'Patients living with HIV (PLWHIV) have compromised muscle metaboreflex, which can cause exercise intolerance. This randomized controlled clinical trial will verify the effects of regular exercise on autonomic and hemodynamic responses to muscle ergoreflex activation in these patients. PLWHIV without regular physical exercise will be randomly assigned into an exercise training or a control group. The exercise training group will undergo regular physical exercise during 12 weeks (60-min session performed 3 times/wk with moderate intensity), while the control group will keep inactive. Another group consisted of inactive HIV-uninfected group will be included. The primary endpoints will be blood pressure and autonomic markers in response to the Stroop Color-Word Test and the activation of muscle ergoreflex, by means of the post-exercise circulatory arrest (PECA), which will be performed with and without the topical application of a capsaicin-based analgesic balm. Secondary endpoints will include heart rate, peripheral vascular resistance, stroke volume, cardiac output, blood lactate concentration, anthropometrics, and handgrip strength. The active and inactive PLWHIV groups will be evaluated before and after the exercise training, while the healthy group only at baseline.', 'detailedDescription': 'HIV-infection is associated to a reduced maximal cardiac output and blunted pressor reflex response to static handgrip exercise, which are suggestive of impaired ergoreflex activation. An abnormal ergoreflex activation may lead to exercise intolerance and increases in cardiovascular risk. Despite the importance of therapeutic strategies in reducing the cardiovascular risk among patients living with HIV, exercise-related effects on ergoreflex sensitivity in these population have not been previously investigated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for people living with HIV:\n\n* diagnosis of HIv infection for at least 5 years;\n* use of combined antiretroviral therapy for at least 3 years;\n* asymptomatic and free from opportunistic diseases at enrollment.\n\nExclusion Criteria:\n\n* regular physical exercise;\n* malnutrition;\n* presence of coronary artery disease, ischemic diseases, pulmonary disease, diabetes, Chagas disease, tuberculosis, heart failure, hypertension;\n* using pacemakers and/or antidepressant, antiarrhythmic or antihypertensive medication, especially beta-blockers.'}, 'identificationModule': {'nctId': 'NCT04512456', 'briefTitle': 'Cardiovascular Responses to Exercise in People Living With HIV/AIDS: Effects of Exercise Training', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Nacional de Cardiologia de Laranjeiras'}, 'officialTitle': 'Autonomic and Hemodynamic Responses to Muscular Ergoreflex Activation in People Living With HIV/AIDS: Effects of Exercise Training.', 'orgStudyIdInfo': {'id': 'FAPERJ E-26/010.100935/2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active HIV-infected patients', 'description': 'Exercise training', 'interventionNames': ['Behavioral: Exercise training']}, {'type': 'NO_INTERVENTION', 'label': 'Inactive HIV-infected patients', 'description': 'No intervention.'}, {'type': 'NO_INTERVENTION', 'label': 'Healthy subjects', 'description': 'No intervention.'}], 'interventions': [{'name': 'Exercise training', 'type': 'BEHAVIORAL', 'description': 'Exercise training performed during 12 weeks, 3 sessions per week of 60 minutes of strength and aerobic exercises.', 'armGroupLabels': ['Active HIV-infected patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20550-900', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Juliana Borges', 'role': 'CONTACT', 'email': 'julipborges@gmail.com', 'phone': '552123340775'}], 'facility': 'Rio de Janeiro State University', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}], 'centralContacts': [{'name': 'Juliana P Borges, Dr.', 'role': 'CONTACT', 'email': 'julipborges@gmail.com', 'phone': '+552123340775'}, {'name': 'Gabriel S Gama', 'role': 'CONTACT', 'email': 'profgabrielgama@gmail.com', 'phone': '+552123340775'}], 'overallOfficials': [{'name': 'Julana P Borges, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rio de Janeiro State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Nacional de Cardiologia de Laranjeiras', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rio de Janeiro State University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Juliana Pereira Borges', 'investigatorAffiliation': 'Rio de Janeiro State University'}}}}