NCT03879993

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2019

Completed
Last Updated

March 20, 2019

Status Verified

March 1, 2019

Enrollment Period

7 months

First QC Date

March 12, 2019

Last Update Submit

March 18, 2019

Conditions

Keywords

ExerciseCognitionBody compositionInflammatory biomarkersCD4

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • CD4 / CD8

    Baseline and eight weeks

  • Concentration of Inflammatory markers

    Baseline and eight weeks

  • Health cellular

    Baseline and eight weeks

Other Outcomes (7)

  • Change in body composition

    Baseline and eight weeks

  • Change in body circumferences

    Baseline and eight weeks

  • Change brachial blood pressure

    Baseline and eight weeks

  • +4 more other outcomes

Study Arms (2)

Exercise group

EXPERIMENTAL

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.

Other: Exercise group

Control group

NO INTERVENTION

Control group was not do any exercise during intervention period. Participants was asked to keep their habitual routine until finish the final evaluations.

Interventions

Resistance training 3 times per week (45-60 minutes of resistance training)

Also known as: Training group
Exercise group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State University of Maringá

Maringá, Paraná, Brazil

Location

Related Publications (18)

  • 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: 28469588BACKGROUND
  • 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: 28161508BACKGROUND
  • 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: 25648055BACKGROUND
  • 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: 28493624BACKGROUND
  • 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: 23934585BACKGROUND
  • 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: 24554483BACKGROUND
  • 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: 16712719BACKGROUND
  • 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: 27892704BACKGROUND
  • 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: 29850491BACKGROUND
  • 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: 23822677BACKGROUND
  • 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: 16438122BACKGROUND
  • 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: 15585779BACKGROUND
  • 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: 10919947BACKGROUND
  • 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: 7712230BACKGROUND
  • 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: 29858504BACKGROUND
  • 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: 27541287BACKGROUND
  • 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: 30369300BACKGROUND
  • 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.

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeMotor Activity

Interventions

Sensitivity Training Groups

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Psychotherapy, GroupSocioenvironmental TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Ademar Avelar, PhD

    State University of Maringá

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Blood collections and subsequent analyzes were done blindly.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 12, 2019

First Posted

March 19, 2019

Study Start

March 1, 2018

Primary Completion

September 30, 2018

Study Completion

February 28, 2019

Last Updated

March 20, 2019

Record last verified: 2019-03

Locations