Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-27 @ 11:11 PM
Study NCT ID:
NCT03879993
Status:
COMPLETED
Last Update Posted:
2019-03-20
First Post:
2019-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Resistance Training in People Living With HIV/AIDS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012681', 'term': 'Sensitivity Training Groups'}], 'ancestors': [{'id': 'D011615', 'term': 'Psychotherapy, Group'}, {'id': 'D012960', 'term': 'Socioenvironmental Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Blood collections and subsequent analyzes were done blindly.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-18', 'studyFirstSubmitDate': '2019-03-12', 'studyFirstSubmitQcDate': '2019-03-15', 'lastUpdatePostDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in body composition', 'timeFrame': 'Baseline and eight weeks', 'description': 'Body composition was evaluated at baseline and after eight weeks of intervention in both groups (EG and CG) using thickness of skin folds (Lange Adipometer). The skin folds of the triceps, subscapular, supra iliac, abdominal, thigh and leg were collected. The data were inserted into formulas appropriate to the population studied for calculating body composition.'}, {'measure': 'Change in body circumferences', 'timeFrame': 'Baseline and eight weeks', 'description': 'Perimeters of arms, chest, abdomen, waist, hip, thigh and leg were measured at baseline and after eight weeks of intervention in both groups (EG and CG).'}, {'measure': 'Change brachial blood pressure', 'timeFrame': 'Baseline and eight weeks', 'description': 'Brachial blood pressure (systolic and diastolic pressures) was assessed through an automatic monitor (HEM-742, Omron Healthcare, Japan) at baseline and after eight weeks of intervention in both groups (EG and CG).'}, {'measure': 'Change autonomic cardiac modulation', 'timeFrame': 'Baseline and eight weeks', 'description': 'The autonomic cardiac modulation was evaluated through a heart rate monitor (Polar, model RS-800, USA) at baseline and after eight weeks of intervention in both groups (EG and CG).'}, {'measure': 'Change in handgrip strength', 'timeFrame': 'Baseline and eight weeks', 'description': 'Handgrip strength was evaluated by handgrip dynamometer at baseline and after eight weeks of intervention in both groups (EG and CG).'}, {'measure': 'Change in flexibility', 'timeFrame': 'Baseline and eight weeks', 'description': 'Flexibility was evaluated by sit and reach test at baseline and after eight weeks of intervention in both groups (EG and CG).'}, {'measure': 'Training load control', 'timeFrame': 'Baseline and eight weeks', 'description': 'Training load control was done by weekly monitoring and adjustment of the weights (kg) used in each exercise.'}], 'primaryOutcomes': [{'measure': 'Change in Cognitive Function', 'timeFrame': 'Baseline and eight weeks', 'description': 'Victoria Stroop, Castro Cunha \\& Martins Stroop and Trail Test were performed at baseline and after eight weeks of intervention in both groups (EG and CG). Blood will be collected and brain-derived neurotrophic factor (BDNF) will be measured by Enzyme-Linked Immunosorbent Assay Method (Human - ELISA Kit) at baseline and after eight weeks of intervention in both groups (EG and CG).'}], 'secondaryOutcomes': [{'measure': 'CD4 / CD8', 'timeFrame': 'Baseline and eight weeks', 'description': 'Blood was collected and cluster of differentiation 4 (T CD4+) and cluster of differentiation 8 (T CD8+) cells was measured by flow cytometry (BD TrucountTM Tubes) with FACSCalibur (Dickinson, New Jersey, USA) at baseline and after eight weeks of intervention in both groups (EG and CG).'}, {'measure': 'Concentration of Inflammatory markers', 'timeFrame': 'Baseline and eight weeks', 'description': 'Blood was collected and interferon (INF-y), interleukin 4 (IL-4), interleukin 6 (IL-6) and interleukin 10 (IL-10) was be measured by Enzyme-Linked Immunosorbent Assay Method (Human - ELISA Kit) at baseline and after eight weeks of intervention in both groups (EG and CG).'}, {'measure': 'Health cellular', 'timeFrame': 'Baseline and eight weeks', 'description': 'Cellular health was evaluated through phase angle value using the bio-electrical bioimpedance method (Biodynamics 450 analyzer, Biodynamics Corporation, Seattle, USA) at baseline and after eight weeks of intervention in both groups (EG and CG).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise', 'Cognition', 'Body composition', 'Inflammatory biomarkers', 'CD4'], 'conditions': ['HIV/AIDS']}, 'referencesModule': {'references': [{'pmid': '28469588', 'type': 'BACKGROUND', 'citation': 'de Assis GG, de Almondes KM. Exercise-dependent BDNF as a Modulatory Factor for the Executive Processing of Individuals in Course of Cognitive Decline. A Systematic Review. Front Psychol. 2017 Apr 19;8:584. doi: 10.3389/fpsyg.2017.00584. eCollection 2017.'}, {'pmid': '28161508', 'type': 'BACKGROUND', 'citation': 'Di Benedetto S, Muller L, Wenger E, Duzel S, Pawelec G. Contribution of neuroinflammation and immunity to brain aging and the mitigating effects of physical and cognitive interventions. Neurosci Biobehav Rev. 2017 Apr;75:114-128. doi: 10.1016/j.neubiorev.2017.01.044. Epub 2017 Feb 1.'}, {'pmid': '25648055', 'type': 'BACKGROUND', 'citation': 'Bossers WJ, van der Woude LH, Boersma F, Hortobagyi T, Scherder EJ, van Heuvelen MJ. A 9-Week Aerobic and Strength Training Program Improves Cognitive and Motor Function in Patients with Dementia: A Randomized, Controlled Trial. Am J Geriatr Psychiatry. 2015 Nov;23(11):1106-16. doi: 10.1016/j.jagp.2014.12.191. Epub 2015 Jan 3.'}, {'pmid': '28493624', 'type': 'BACKGROUND', 'citation': 'Dinoff A, Herrmann N, Swardfager W, Lanctot KL. The effect of acute exercise on blood concentrations of brain-derived neurotrophic factor in healthy adults: a meta-analysis. Eur J Neurosci. 2017 Jul;46(1):1635-1646. doi: 10.1111/ejn.13603. Epub 2017 Jun 19.'}, {'pmid': '23934585', 'type': 'BACKGROUND', 'citation': 'Dufour CA, Marquine MJ, Fazeli PL, Henry BL, Ellis RJ, Grant I, Moore DJ; HNRP Group. Physical exercise is associated with less neurocognitive impairment among HIV-infected adults. J Neurovirol. 2013 Oct;19(5):410-7. doi: 10.1007/s13365-013-0184-8. Epub 2013 Aug 10.'}, {'pmid': '24554483', 'type': 'BACKGROUND', 'citation': 'Fazeli PL, Woods SP, Heaton RK, Umlauf A, Gouaux B, Rosario D, Moore RC, Grant I, Moore DJ; HNRP Group. An active lifestyle is associated with better neurocognitive functioning in adults living with HIV infection. J Neurovirol. 2014 Jun;20(3):233-42. doi: 10.1007/s13365-014-0240-z. Epub 2014 Feb 20.'}, {'pmid': '16712719', 'type': 'BACKGROUND', 'citation': 'Ghafouri M, Amini S, Khalili K, Sawaya BE. HIV-1 associated dementia: symptoms and causes. Retrovirology. 2006 May 19;3:28. doi: 10.1186/1742-4690-3-28.'}, {'pmid': '27892704', 'type': 'BACKGROUND', 'citation': 'McDermott A, Zaporojan L, McNamara P, Doherty CP, Redmond J, Forde C, Gormley J, Egana M, Bergin C. The effects of a 16-week aerobic exercise programme on cognitive function in people living with HIV. AIDS Care. 2017 Jun;29(6):667-674. doi: 10.1080/09540121.2016.1263723. Epub 2016 Nov 28.'}, {'pmid': '29850491', 'type': 'BACKGROUND', 'citation': 'de Souza DC, da Silva JC, Matos FO, Okano AH, Bazotte RB, Avelar A. The Effect of a Short Period of Supplementation with Glutamine Dipeptide on the Cognitive Responses after a Resistance Training Session of Women with HIV/AIDS: A Randomized Double-Blind Placebo-Controlled Crossover Study. Biomed Res Int. 2018 Apr 3;2018:2525670. doi: 10.1155/2018/2525670. eCollection 2018.'}, {'pmid': '23822677', 'type': 'BACKGROUND', 'citation': 'Llames L, Baldomero V, Iglesias ML, Rodota LP. [Values of the phase angle by bioelectrical impedance; nutritional status and prognostic value]. Nutr Hosp. 2013 Mar-Apr;28(2):286-95. doi: 10.3305/nh.2013.28.2.6306. Spanish.'}, {'pmid': '16438122', 'type': 'BACKGROUND', 'citation': 'Meynell J, Barroso J. Bioimpedance analysis and HIV-related fatigue. J Assoc Nurses AIDS Care. 2005 Mar-Apr;16(2):13-22. doi: 10.1016/j.jana.2005.01.006.'}, {'pmid': '15585779', 'type': 'BACKGROUND', 'citation': 'Gupta D, Lammersfeld CA, Burrows JL, Dahlk SL, Vashi PG, Grutsch JF, Hoffman S, Lis CG. Bioelectrical impedance phase angle in clinical practice: implications for prognosis in advanced colorectal cancer. Am J Clin Nutr. 2004 Dec;80(6):1634-8. doi: 10.1093/ajcn/80.6.1634.'}, {'pmid': '10919947', 'type': 'BACKGROUND', 'citation': 'Schwenk A, Beisenherz A, Romer K, Kremer G, Salzberger B, Elia M. Phase angle from bioelectrical impedance analysis remains an independent predictive marker in HIV-infected patients in the era of highly active antiretroviral treatment. Am J Clin Nutr. 2000 Aug;72(2):496-501. doi: 10.1093/ajcn/72.2.496.'}, {'pmid': '7712230', 'type': 'BACKGROUND', 'citation': 'Ott M, Fischer H, Polat H, Helm EB, Frenz M, Caspary WF, Lembcke B. Bioelectrical impedance analysis as a predictor of survival in patients with human immunodeficiency virus infection. J Acquir Immune Defic Syndr Hum Retrovirol. 1995 May 1;9(1):20-5.'}, {'pmid': '29858504', 'type': 'BACKGROUND', 'citation': 'Tomeleri CM, Ribeiro AS, Cavaglieri CR, Deminice R, Schoenfeld BJ, Schiavoni D, Dos Santos L, de Souza MF, Antunes M, Venturini D, Barbosa DS, Sardinha LB, Cyrino ES. Correlations between resistance training-induced changes on phase angle and biochemical markers in older women. Scand J Med Sci Sports. 2018 Oct;28(10):2173-2182. doi: 10.1111/sms.13232. Epub 2018 Jun 25.'}, {'pmid': '27541287', 'type': 'BACKGROUND', 'citation': 'Souza MF, Tomeleri CM, Ribeiro AS, Schoenfeld BJ, Silva AM, Sardinha LB, Cyrino ES. Effect of resistance training on phase angle in older women: A randomized controlled trial. Scand J Med Sci Sports. 2017 Nov;27(11):1308-1316. doi: 10.1111/sms.12745. Epub 2016 Aug 19.'}, {'pmid': '30369300', 'type': 'BACKGROUND', 'citation': 'Deresz LF, Scholer CM, de Bittencourt PIHJ, Karsten M, Ikeda MLR, Sonza A, Dal Lago P. Exercise training reduces oxidative stress in people living with HIV/AIDS: a pilot study. HIV Clin Trials. 2018 Aug;19(4):152-157. doi: 10.1080/15284336.2018.1481247. Epub 2018 Oct 27.'}, {'pmid': '40711680', 'type': 'DERIVED', 'citation': 'de Souza DC, Marchini KB, Nunhes PM, Domingues WJR, Bertolini DA, Oliveira V, Mazzardo O, Avelar A. Resistance Training Improves Cognitive Function and Depression Without Changing BDNF Levels in People Living with HIV: a Randomized Controlled Clinical Trial. AIDS Behav. 2025 Dec;29(12):3877-3886. doi: 10.1007/s10461-025-04824-6. Epub 2025 Jul 25.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study will be to verify effects of resistance training in people living with HIV/AIDS.', 'detailedDescription': 'The aim of this study was verify effects of resistance training in cognitive function, body composition and biochemical parameters of inflammation and oxidative stress in people living with HIV/AIDS. The sample was composed by patients with HIV/AIDS of both sexes. The patients were randomized in two groups, a exercise group (EG), which was receive intervention with eight weeks of resistance training, and a control group (CG), that was not to do exercise. The cognitive function was analyzed with Stroop Test and Trail Test; body composition was evaluated by bioimpedance; blood tests was use to analyze biochemical parameters of inflammation and oxidative stress. For statistical analysis was used ANOVA of two factors for repeated measurements, having the (EG and PG) group and the time (pre and post exercise). Level of significance adopted was P \\< 0,05.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnostic for HIV/AIDS.\n* Clinical condition and viral count stabilized.\n* Have been using (HAART) for 6 months or more.\n* Not have participated in physical exercise programs in six months before beginning of study.\n* Not have muscle or joint injuries that make it impossible to practice physical activity.\n* Not be pregnant.\n\nExclusion Criteria:\n\n* Not attending more than 15% of the intervention sessions or visits to the laboratory.\n* Aggravation of the disease.\n* Stick to a physical activity program in addition to that offered by the study.'}, 'identificationModule': {'nctId': 'NCT03879993', 'briefTitle': 'Resistance Training in People Living With HIV/AIDS', 'organization': {'class': 'OTHER', 'fullName': 'State University of Maringá'}, 'officialTitle': 'Effects of Resistance Training in People Living With HIV/AIDS', 'orgStudyIdInfo': {'id': 'Exercise and HIV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise group', 'description': 'Exercise group was resistance training three times per week, during 45 to 60 minutes per day. Training program was composed by bench press, leg press 45°, lat pulldown, knee extension, dumbbell lateral raise, horizontal leg curl, triceps pulldown, seated calf raise, biceps curls and abdominal. Participants should complete 3 series with 8-12 repetitions of each exercise, which was supervised by trained research personnel. There were 60 seconds of interval between series and exercises were separated by a 120 seconds recovery period.', 'interventionNames': ['Other: Exercise group']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Control group was not do any exercise during intervention period. Participants was asked to keep their habitual routine until finish the final evaluations.'}], 'interventions': [{'name': 'Exercise group', 'type': 'OTHER', 'otherNames': ['Training group'], 'description': 'Resistance training 3 times per week (45-60 minutes of resistance training)', 'armGroupLabels': ['Exercise group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Maringá', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'State University of Maringá', 'geoPoint': {'lat': -23.42528, 'lon': -51.93861}}], 'overallOfficials': [{'name': 'Ademar Avelar, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'State University of Maringá'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of Maringá', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ademar Avelar de Almeida Junior', 'investigatorAffiliation': 'State University of Maringá'}}}}