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Lipodystrophy Syndrome, HIVPVHANCT03075332

Detraining in People Living With HIV/AIDS

A study testing combined training in people with Lipodystrophy Syndrome, HIV and Sarcopenia, run by Universidade Federal do Rio Grande do Norte at 2 sites in Brazil.

Completed

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

Official record
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Trial summary

The goal of this study was to evaluate the effect of detraining in the components of physical aptitude of people living with HIV/Aids (PVHA). Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Lipodystrophy Syndrome, HIV, Sarcopenia
What is being tested?
combined training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
2 sitesBrazil
Study dates
19 Feb 2016to 23 Jul 2016
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 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Group experience to have a diagnosis of at least 2 years living with HIV / AIDS being in clinical follow-up in the Specialized Attention Services in HIV / AIDS (SAE), using ART, TCD4 lymphocyte count equal to or greater than 500 copies / mm³, viral load Undetectable (≤ 50 copies / mm³)
  • Group control without any diagnosis of HIV / AIDS or any other pathology. Both groups completed the exercise program with a minimum frequency of 75%.

Who cannot join

  • Both groups taking part in any physical exercise in time of detraining

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites

  • Juliany de Souza Araujo

    Natal, Rio Grande do Norte, 59152600

  • Juliany de Souza Araujo

    Parnamirim, Rio Grande do Norte, 59152600

Other trials in Brazil

About this study

Official title: Detraining in the Components of Physical Aptitude in People Living With HIV/ AIDS

The goal of this study was to evaluate the effect of detraining in the components of physical aptitude of people living with HIV/Aids (PVHA).

Read the detailed description

The study was experimental with a sample composed by an Experimental Group (EG) with 11 PVHA, under antiretroviral therapy and a Control Group (CG) with 10 individuals without the infection; all which were under medical release and insufficiently active. The body composition was evaluated through the DXA, as well as the cardiorespiratory aptitude through the ergometer and the strength of the upper and lower limbs through dynamometry. Both groups conducted interventions with concurrent training for 15 weeks and the interruption of exercise was evaluated after a period of 5 weeks.

Being tested
combined training
Keywords
Detraining, Physical aptitude, HIV
Medical subject headings
HIV-Associated Lipodystrophy Syndrome, Sarcopenia

What participants receive

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

  • combined trainingOther

    Combined training consisting of aerobic and resisted training in the same training session for 15 weeks followed by 5 weeks of detraining

Study groups in NCT03075332
Study groupRoleWhat they receive
protocol with physical exerciseExperimentalBoth groups underwent a combined training intervention consisting of aerobic and resisted exercises in the same training session
Receives: Other: combined training

What is being measured

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

  1. Capacity cardiorespiratory

    ml (cardiorespiratory aptitude through the ergometer)

    Measured: 21 weeks

Secondary outcomes (1)

  1. test force

    kg (strength of the upper and lower limbs through dynamometry)

    Measured: 21 weeks

Timeline

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

  1. First posted9 Mar 2017
  2. Study start19 Feb 2016
  3. Primary completion21 Jun 2016
  4. Study completion23 Jul 2016

Resources

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
Prevention
Intervention model
Sequential
Model description
This is a longitudinal study of the non-randomized experimental type, presenting a non-probabilistic sample for convenience and independent groups. The sample consisted of 21 individuals divided into 2 groups: Experimental Group (EG) and Control Group (CG). The EG was composed of 11 people living with HIV/AIDS and CG composed of 10 people with no infection
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03075332
Sponsor's protocol ID
VIVER MAIS
Acronym
PVHA
Status last verified
Feb 2017
First submitted
9 Feb 2017
Last updated
9 Mar 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: It is not done sharing since the individuals involved in the people are vulnerable and the secrecy is rescued

Publications

  • Warshaw MG, Carey VJ, McFarland EJ, Dawson L, Abrams E, Melvin A, Fairlie L, Spiegel H, Jay J, Agwu AL; IMPAACT P1094 Team. The interaction between equipoise and logistics in clinical trials: A case study. Clin Trials. 2017 Jun;14(3):314-318. doi: 10.1177/1740774517690734. Epub 2017 Jan 31.

    PubMed 28135804

  • Li A, McCabe T, Silverstein E, Dragan S, Salbach NM, Zobeiry M, Beldick S, Godi C, O'Brien KK. Community-Based Exercise in the Context of HIV: Factors to Consider when Developing and Implementing Community-Based Exercise Programs for People Living with HIV. J Int Assoc Provid AIDS Care. 2017 May/Jun;16(3):267-275. doi: 10.1177/2325957416686836. Epub 2017 Jan 11.

    PubMed 28074681

  • Gomes Neto M, Conceicao CS, Oliveira Carvalho V, Brites C. Effects of Combined Aerobic and Resistance Exercise on Exercise Capacity, Muscle Strength and Quality of Life in HIV-Infected Patients: A Systematic Review and Meta-Analysis. PLoS One. 2015 Sep 17;10(9):e0138066. doi: 10.1371/journal.pone.0138066. eCollection 2015.

    PubMed 26378794

  • Poton R, Polito M, Farinatti P. Effects of resistance training in HIV-infected patients: A meta-analysis of randomised controlled trials. J Sports Sci. 2017 Dec;35(24):2380-2389. doi: 10.1080/02640414.2016.1267389. Epub 2016 Dec 21.

    PubMed 28001474

  • Chitu-Tisu CE, Barbu EC, Lazar M, Bojinca M, Tudor AM, Hristea A, Abagiu AO, Ion DA, Badarau AI. Body composition in HIV-infected patients receiving highly active antiretroviral therapy. Acta Clin Belg. 2017 Feb;72(1):55-62. doi: 10.1080/17843286.2016.1240426. Epub 2016 Oct 11.

    PubMed 27724840

  • Araujo JS, de Medeiros RCDSC, da Silva TAL, de Medeiros DC, de Medeiros JA, Dos Santos IK, Wilde P, Cabral BGAT, Medeiros RMV, Dantas PMS. Effect of Training and Detraining in the Components of Physical Fitness in People Living With HIV/AIDS. Front Physiol. 2021 Sep 22;12:586753. doi: 10.3389/fphys.2021.586753. eCollection 2021.

    PubMed 34630129

Questions about this trial

What is this clinical trial studying?

A study testing combined training in people with Lipodystrophy Syndrome, HIV and Sarcopenia, run by Universidade Federal do Rio Grande do Norte at 2 sites 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 2 inclusion and 1 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 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Capacity cardiorespiratory (time frame: 21 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 NCT03075332, which also lists 6 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 9 Mar 2017.

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