- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03075332
Detraining in People Living With HIV/AIDS (PVHA)
March 8, 2017 updated by: JULIANY DE SOUZA ARAUJO, Universidade Federal do Rio Grande do Norte
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
RN
-
Natal, RN, Brazil, 59152600
- Juliany de Souza Araujo
-
Parnamirim, RN, Brazil, 59152600
- Juliany de Souza Araujo
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: protocol with physical exercise
Both groups underwent a combined training intervention consisting of aerobic and resisted exercises in the same training session
|
Combined training consisting of aerobic and resisted training in the same training session for 15 weeks followed by 5 weeks of detraining
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Capacity cardiorespiratory
Time Frame: 21 weeks
|
ml (cardiorespiratory aptitude through the ergometer)
|
21 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
test force
Time Frame: 21 weeks
|
kg (strength of the upper and lower limbs through dynamometry)
|
21 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
body composition
Time Frame: 21 weeks
|
kg (body composition was evaluated through the DXA)
|
21 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: juliany araujo, Universidade Federal do Rio Grande do Norte
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 19, 2016
Primary Completion (Actual)
June 21, 2016
Study Completion (Actual)
July 23, 2016
Study Registration Dates
First Submitted
February 9, 2017
First Submitted That Met QC Criteria
March 8, 2017
First Posted (Actual)
March 9, 2017
Study Record Updates
Last Update Posted (Actual)
March 9, 2017
Last Update Submitted That Met QC Criteria
March 8, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Nervous System Diseases
- Skin Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Neurologic Manifestations
- Neuromuscular Manifestations
- Pathological Conditions, Anatomical
- Lipid Metabolism Disorders
- Muscular Atrophy
- Atrophy
- HIV Infections
- Skin Diseases, Metabolic
- Sarcopenia
- Lipodystrophy
- HIV-Associated Lipodystrophy Syndrome
Other Study ID Numbers
- VIVER MAIS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
It is not done sharing since the individuals involved in the people are vulnerable and the secrecy is rescued
Study Data/Documents
-
Ethics committee project
Information identifier: plataforma brasilInformation comments: all project
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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