Resistance Training in People Living With HIV/AIDS

HIV/AIDS Clinical Trial

Official title:

Effects of Resistance Training in People Living With HIV/AIDS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03879993
• Other study ID #: Exercise and HIV
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: March 2019
• Source: State University of Maringá
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study will be to verify effects of resistance training in people living with HIV/AIDS.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: February 28, 2019
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV/AIDS

Intervention

Other:
• Exercise group
Resistance training 3 times per week (45-60 minutes of resistance training)

Locations

Country	Name	City	State
Brazil	State University of Maringá	Maringá	PR

Sponsors (1)

Lead Sponsor	Collaborator
State University of Maringá

Country where clinical trial is conducted

Brazil, 

References & Publications (17)

Bossers WJ, van der Woude LH, Boersma F, Hortobágyi 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. — View 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. Review. — View 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. — View Citation

Deresz LF, Schöler 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. — View Citation

Di Benedetto S, Müller L, Wenger E, Düzel 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. Review. — View Citation

Dinoff A, Herrmann N, Swardfager W, Lanctôt 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. Review. — View 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. — View 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. — View Citation

Ghafouri M, Amini S, Khalili K, Sawaya BE. HIV-1 associated dementia: symptoms and causes. Retrovirology. 2006 May 19;3:28. Review. — View 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. — View 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. Review. Spanish. — View Citation

McDermott A, Zaporojan L, McNamara P, Doherty CP, Redmond J, Forde C, Gormley J, Egaña 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. — View Citation

Meynell J, Barroso J. Bioimpedance analysis and HIV-related fatigue. J Assoc Nurses AIDS Care. 2005 Mar-Apr;16(2):13-22. — View 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. — View Citation

Schwenk A, Beisenherz A, Römer 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. — View 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. — View 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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in body composition	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.	Baseline and eight weeks
Other	Change in body circumferences	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).	Baseline and eight weeks
Other	Change brachial blood pressure	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).	Baseline and eight weeks
Other	Change autonomic cardiac modulation	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).	Baseline and eight weeks
Other	Change in handgrip strength	Handgrip strength was evaluated by handgrip dynamometer at baseline and after eight weeks of intervention in both groups (EG and CG).	Baseline and eight weeks
Other	Change in flexibility	Flexibility was evaluated by sit and reach test at baseline and after eight weeks of intervention in both groups (EG and CG).	Baseline and eight weeks
Other	Training load control	Training load control was done by weekly monitoring and adjustment of the weights (kg) used in each exercise.	Baseline and eight weeks
Primary	Change in Cognitive Function	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).	Baseline and eight weeks
Secondary	CD4 / CD8	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).	Baseline and eight weeks
Secondary	Concentration of Inflammatory markers	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).	Baseline and eight weeks
Secondary	Health cellular	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).	Baseline and eight weeks