Resistance Training in People Living With HIV/AIDS

A study testing Exercise group in people with HIV/AIDS, run by State University of Maringá at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 to 65 years
Conditions the study is for: HIV/AIDS
What is being tested?: Exercise group
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 49 participants
Where: 1 siteBrazil
Study dates: 1 Mar 2018to 28 Feb 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

State University of Maringá
Maringá, Paraná

Other trials in Brazil

About this study

Official title: 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.

Read the detailed 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.

Conditions: HIV/AIDS
Being tested: Exercise group
Keywords: Exercise, Cognition, Body composition, Inflammatory biomarkers, CD4
Medical subject headings: Acquired Immunodeficiency Syndrome, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Exercise groupOther
Also called Training group
Resistance training 3 times per week (45-60 minutes of resistance training)

Study groups in NCT03879993
Study group	Role	What they receive
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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Baseline and eight weeks

Secondary outcomes (3)

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).
Measured: Baseline and eight weeks
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).
Measured: Baseline and eight weeks
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).
Measured: Baseline and eight weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 201828 Feb 2019

First posted19 Mar 2019
Study start1 Mar 2018
Primary completion30 Sep 2018
Study completion28 Feb 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (18)Papers the sponsor has linked to this study.
Other trials for HIV/AIDSStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03879993
Sponsor's protocol ID: Exercise and HIV
Status last verified: Mar 2019
First submitted: 12 Mar 2019
Last updated: 20 Mar 2019
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 28469588
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.
PubMed 28161508
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.
PubMed 25648055
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.
PubMed 28493624
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.
PubMed 23934585
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.
PubMed 24554483
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.
PubMed 16712719
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.
PubMed 27892704
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.
PubMed 29850491
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.
PubMed 23822677
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.
PubMed 16438122
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.
PubMed 15585779
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.
PubMed 10919947
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.
PubMed 7712230
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.
PubMed 29858504

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All HIV/AIDS trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Resistance Training in People Living With HIV/AIDS
ClinicalTrials.gov ID: NCT03879993
Acronym / sponsor ID: Exercise and HIV
Conditions: HIV/AIDS
Keywords: Exercise, Cognition, Body composition, Inflammatory biomarkers, CD4
Study type: Interventional
Recruitment status: Completed
Enrolment: 49 participants (actual)
Lead sponsor: State University of MaringáUniversity, hospital or other
Study start: 1 Mar 2018 (actual)
Primary completion: 30 Sep 2018 (actual)
Study completion: 28 Feb 2019 (actual)
First posted: 19 Mar 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Exercise group	Experimental	Other: Exercise groupExercise 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.
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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Exercise groupAlso: Training groupResistance training 3 times per week (45-60 minutes of resistance training)	Other	Exercise group

Primary outcome

Change in Cognitive Function
Time frame: Baseline and eight weeks
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).

3 secondary outcomes

CD4 / CD8
Time frame: Baseline and eight weeks
Concentration of Inflammatory markers
Time frame: Baseline and eight weeks
Health cellular
Time frame: Baseline and eight weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
Background: PubMed 28469588de 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.
Background: PubMed 28161508Di 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.
Background: PubMed 25648055Bossers 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.
Background: PubMed 28493624Dinoff 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.
Background: PubMed 23934585Dufour 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.
Background: PubMed 24554483Fazeli 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.
Background: PubMed 16712719Ghafouri 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.
Background: PubMed 27892704McDermott 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.
Background: PubMed 29850491de 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.
Background: PubMed 23822677Llames 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.
Background: PubMed 16438122Meynell 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.
Background: PubMed 15585779Gupta 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ademar Avelar, PhD principal investigator

State University of Maringá

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Exercise group in people with HIV/AIDS, run by State University of Maringá at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Cognitive Function (time frame: Baseline and eight weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03879993, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2019.