NCT03075332

Brief 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

February 19, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2017

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 9, 2017

Completed
Last Updated

March 9, 2017

Status Verified

February 1, 2017

Enrollment Period

4 months

First QC Date

February 9, 2017

Last Update Submit

March 8, 2017

Conditions

Keywords

DetrainingPhysical aptitudeHIV

Outcome Measures

Primary Outcomes (1)

  • Capacity cardiorespiratory

    ml (cardiorespiratory aptitude through the ergometer)

    21 weeks

Secondary Outcomes (1)

  • test force

    21 weeks

Other Outcomes (1)

  • body composition

    21 weeks

Study Arms (1)

protocol with physical exercise

EXPERIMENTAL

Both groups underwent a combined training intervention consisting of aerobic and resisted exercises in the same training session

Other: combined training

Interventions

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

protocol with physical exercise

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Juliany de Souza Araujo

Natal, Rio Grande do Norte, 59152600, Brazil

Location

Juliany de Souza Araujo

Parnamirim, Rio Grande do Norte, 59152600, Brazil

Location

Related Publications (6)

  • 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.

    PMID: 28135804BACKGROUND
  • 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.

    PMID: 28074681BACKGROUND
  • 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.

    PMID: 26378794BACKGROUND
  • 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.

    PMID: 28001474BACKGROUND
  • 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.

    PMID: 27724840BACKGROUND
  • 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.

MeSH Terms

Conditions

HIV-Associated Lipodystrophy SyndromeSarcopenia

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesLipodystrophySkin Diseases, MetabolicSkin DiseasesSkin and Connective Tissue DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesImmunologic Deficiency SyndromesImmune System DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • juliany araujo

    Universidade Federal do Rio Grande do Norte

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 9, 2017

First Posted

March 9, 2017

Study Start

February 19, 2016

Primary Completion

June 21, 2016

Study Completion

July 23, 2016

Last Updated

March 9, 2017

Record last verified: 2017-02

Locations