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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03075332
Other study ID # VIVER MAIS
Secondary ID
Status Completed
Phase N/A
First received February 9, 2017
Last updated March 8, 2017
Start date February 19, 2016
Est. completion date July 23, 2016

Study information

Verified date February 2017
Source Universidade Federal do Rio Grande do Norte
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 2
Est. completion date July 23, 2016
Est. primary completion date June 21, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Brazil Juliany de Souza Araujo Natal RN
Brazil Juliany de Souza Araujo Parnamirim RN

Sponsors (1)

Lead Sponsor Collaborator
Universidade Federal do Rio Grande do Norte

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

Chi?u-Ti?u 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. — View Citation

Gomes Neto M, Conceição 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. — View 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. J Int Assoc Provid AIDS Care. 2017 Jan 1:2325957416686836. doi: 10.1177/2325957416686836. [Epub ahead of print] — View 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. 2016 Dec 21:1-10. doi: 10.1080/02640414.2016.1267389. [Epub ahead of print] — View 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 Jan 1:1740774517690734. doi: 10.1177/1740774517690734. [Epub ahead of print] — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other body composition kg (body composition was evaluated through the DXA) 21 weeks
Primary Capacity cardiorespiratory ml (cardiorespiratory aptitude through the ergometer) 21 weeks
Secondary test force kg (strength of the upper and lower limbs through dynamometry) 21 weeks
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