Back to resultsDetraining in People Living With HIV/AIDS (PVHA)
Primary Purpose
Lipodystrophy Syndrome, HIV, Sarcopenia
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
combined training
Sponsored by
About this trial
This is an interventional prevention trial for Lipodystrophy Syndrome, HIV focused on measuring Detraining, Physical aptitude, HIV
Eligibility Criteria
Inclusion Criteria:
- 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%.
Exclusion Criteria:
- Both groups taking part in any physical exercise in time of detraining
Sites / Locations
- Juliany de Souza Araujo
- Juliany de Souza Araujo
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
protocol with physical exercise
Arm Description
Both groups underwent a combined training intervention consisting of aerobic and resisted exercises in the same training session
Outcomes
Primary Outcome Measures
Capacity cardiorespiratory
ml (cardiorespiratory aptitude through the ergometer)
Secondary Outcome Measures
test force
kg (strength of the upper and lower limbs through dynamometry)
Full Information
NCT ID
NCT03075332
First Posted
February 9, 2017
Last Updated
March 8, 2017
Sponsor
Universidade Federal do Rio Grande do Norte
1. Study Identification
Unique Protocol Identification Number
NCT03075332
Brief Title
Detraining in People Living With HIV/AIDS
Acronym
PVHA
Official Title
Detraining in the Components of Physical Aptitude in People Living With HIV/ AIDS
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 19, 2016 (Actual)
Primary Completion Date
June 21, 2016 (Actual)
Study Completion Date
July 23, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio Grande do Norte
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipodystrophy Syndrome, HIV, Sarcopenia
Keywords
Detraining, Physical aptitude, HIV
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
protocol with physical exercise
Arm Type
Experimental
Arm Description
Both groups underwent a combined training intervention consisting of aerobic and resisted exercises in the same training session
Intervention Type
Other
Intervention Name(s)
combined training
Intervention Description
Combined training consisting of aerobic and resisted training in the same training session for 15 weeks followed by 5 weeks of detraining
Primary Outcome Measure Information:
Title
Capacity cardiorespiratory
Description
ml (cardiorespiratory aptitude through the ergometer)
Time Frame
21 weeks
Secondary Outcome Measure Information:
Title
test force
Description
kg (strength of the upper and lower limbs through dynamometry)
Time Frame
21 weeks
Other Pre-specified Outcome Measures:
Title
body composition
Description
kg (body composition was evaluated through the DXA)
Time Frame
21 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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%.
Exclusion Criteria:
Both groups taking part in any physical exercise in time of detraining
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
juliany araujo
Organizational Affiliation
Universidade Federal do Rio Grande do Norte
Official's Role
Principal Investigator
Facility Information:
Facility Name
Juliany de Souza Araujo
City
Natal
State/Province
RN
ZIP/Postal Code
59152600
Country
Brazil
Facility Name
Juliany de Souza Araujo
City
Parnamirim
State/Province
RN
ZIP/Postal Code
59152600
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
It is not done sharing since the individuals involved in the people are vulnerable and the secrecy is rescued
Citations:
PubMed Identifier
28135804
Citation
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.
Results Reference
background
PubMed Identifier
28074681
Citation
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.
Results Reference
background
PubMed Identifier
26378794
Citation
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.
Results Reference
background
PubMed Identifier
28001474
Citation
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.
Results Reference
background
PubMed Identifier
27724840
Citation
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.
Results Reference
background
PubMed Identifier
34630129
Citation
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.
Results Reference
derived
Available IPD and Supporting Information:
Available IPD/Information Type
Ethics committee project
Available IPD/Information URL
http://aplicacao.saude.gov.br/plataformabrasil/visao/pesquisador/gerirPesquisa/gerirPesquisaAgrupador.jsf
Available IPD/Information Identifier
plataforma brasil
Available IPD/Information Comments
all project
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Detraining in People Living With HIV/AIDS
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