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

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

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

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

  1. Ethics committee project
    Information identifier: plataforma brasil
    Information 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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