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- Klinische proef NCT03879993
Resistance Training in People Living With HIV/AIDS
18 maart 2019 bijgewerkt door: Ademar Avelar de Almeida Junior, State University of Maringá
Effects of Resistance Training in People Living With HIV/AIDS
The aim of this study will be to verify effects of resistance training in people living with HIV/AIDS.
Studie Overzicht
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
49
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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PR
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Maringá, PR, Brazilië
- State University of Maringá
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 65 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Clinical diagnostic for HIV/AIDS.
- Clinical condition and viral count stabilized.
- Have been using (HAART) for 6 months or more.
- Not have participated in physical exercise programs in six months before beginning of study.
- Not have muscle or joint injuries that make it impossible to practice physical activity.
- Not be pregnant.
Exclusion Criteria:
- Not attending more than 15% of the intervention sessions or visits to the laboratory.
- Aggravation of the disease.
- Stick to a physical activity program in addition to that offered by the study.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Exercise group
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.
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Resistance training 3 times per week (45-60 minutes of resistance training)
Andere namen:
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Geen tussenkomst: Control group
Control group was not do any exercise during intervention period.
Participants was asked to keep their habitual routine until finish the final evaluations.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Cognitive Function
Tijdsspanne: Baseline and eight weeks
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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).
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Baseline and eight weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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CD4 / CD8
Tijdsspanne: Baseline and eight weeks
|
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).
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Baseline and eight weeks
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Concentration of Inflammatory markers
Tijdsspanne: Baseline and eight weeks
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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).
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Baseline and eight weeks
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Health cellular
Tijdsspanne: Baseline and eight weeks
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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).
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Baseline and eight weeks
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in body composition
Tijdsspanne: Baseline and eight weeks
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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.
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Baseline and eight weeks
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Change in body circumferences
Tijdsspanne: Baseline and eight weeks
|
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).
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Baseline and eight weeks
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Change brachial blood pressure
Tijdsspanne: Baseline and eight weeks
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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).
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Baseline and eight weeks
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Change autonomic cardiac modulation
Tijdsspanne: Baseline and eight weeks
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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).
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Baseline and eight weeks
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Change in handgrip strength
Tijdsspanne: Baseline and eight weeks
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Handgrip strength was evaluated by handgrip dynamometer at baseline and after eight weeks of intervention in both groups (EG and CG).
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Baseline and eight weeks
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Change in flexibility
Tijdsspanne: Baseline and eight weeks
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Flexibility was evaluated by sit and reach test at baseline and after eight weeks of intervention in both groups (EG and CG).
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Baseline and eight weeks
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Training load control
Tijdsspanne: Baseline and eight weeks
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Training load control was done by weekly monitoring and adjustment of the weights (kg) used in each exercise.
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Baseline and eight weeks
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Ademar Avelar, PhD, State University of Maringá
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 maart 2018
Primaire voltooiing (Werkelijk)
30 september 2018
Studie voltooiing (Werkelijk)
28 februari 2019
Studieregistratiedata
Eerst ingediend
12 maart 2019
Eerst ingediend dat voldeed aan de QC-criteria
15 maart 2019
Eerst geplaatst (Werkelijk)
19 maart 2019
Updates van studierecords
Laatste update geplaatst (Werkelijk)
20 maart 2019
Laatste update ingediend die voldeed aan QC-criteria
18 maart 2019
Laatst geverifieerd
1 maart 2019
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- RNA-virusinfecties
- Virusziekten
- Infecties
- Door bloed overgedragen infecties
- Overdraagbare ziekten
- Seksueel overdraagbare aandoeningen, viraal
- Seksueel overdraagbare aandoeningen
- Lentivirus-infecties
- Retroviridae-infecties
- Immunologische deficiëntie syndromen
- Ziekten van het immuunsysteem
- Langzame virusziekten
- HIV-infecties
- Verworven Immunodeficiëntie Syndroom
Andere studie-ID-nummers
- Exercise and HIV
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .