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Trial record 33 of 10364 for:    strength

Strength Training With Vascular Occlusion in Patients Harboring With HIV/Aids

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ClinicalTrials.gov Identifier: NCT02783417
Recruitment Status : Terminated
First Posted : May 26, 2016
Last Update Posted : November 1, 2017
Sponsor:
Information provided by (Responsible Party):
THIAGO CÂNDIDO ALVES, University of Sao Paulo

Brief Summary:
The use of antiretroviral therapy (ART) could prevent depression of the immune system of patients harboring with Human Immunodeficiency Virus (HIV), providing increased life expectancy, changing the classification of HIV / AIDS into a chronic illness. However prolonged use of ARTincreases the prevalence of lipodystrophy syndrome (SL), characterized by inadequate distribution of body fat and changes in lipid profile, associated with a significantly increased cardiovascular risk, among others. The practice of strength training (ST) helps in controlling SL, providing improved lipid profile and the quality of life of these patients. However, due to increased cardiovascular risk and physical weakness resulting from SL, the ST with vascular occlusion (STOV) could be a viable alternative training, to use low load (10-30% of maximal work capacity) with similar benefits ST traditional (STT), as already proven in other populations. The STOV is justified by the lower neuromuscular overhead, increasing the number of patients able to participate in this complementary therapy. The objective was to assess the impact of the combined strength training with vascular occlusion on SL and the skeletal muscle tissue in people harboring with HIV/Aids.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Other: Strength Training Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Resistance Training with Blood Flow Restriction
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Strength Training With Vascular Occlusion on the Syndrome Lipodystrophy in Patients Harboring With HIV/Aids
Study Start Date : August 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Training with vascular occlusion
Strength Training: intensity of 30% of 1RM, with vascular occlusion pressure in members.
Other: Strength Training

G1: will be three series of repetitions to the concentric failure with occlusion pressure, with the two-second intervals for the concentric phase and two seconds for the eccentric phase (Moore et al., 2004;. LAURENTINO et al, 2012), with 30% of 1RM and intermittent vascular occlusion members. Will be provided one-minute intervals between sets and exercises (with the exception of the interval between the exercises of upper and lower; being provided at present a three-minute break for removal and installation of restrictive cuffs).

G2: will be three series of repetitions to the concentric failure, with cadence of movement and intervals similar to the G1. The intensity will be 80% of 1RM without occlusion.


Experimental: Traditional strength training
Strength Training: intensity of 80% of 1RM, without vascular occlusion pressure in members
Other: Strength Training

G1: will be three series of repetitions to the concentric failure with occlusion pressure, with the two-second intervals for the concentric phase and two seconds for the eccentric phase (Moore et al., 2004;. LAURENTINO et al, 2012), with 30% of 1RM and intermittent vascular occlusion members. Will be provided one-minute intervals between sets and exercises (with the exception of the interval between the exercises of upper and lower; being provided at present a three-minute break for removal and installation of restrictive cuffs).

G2: will be three series of repetitions to the concentric failure, with cadence of movement and intervals similar to the G1. The intensity will be 80% of 1RM without occlusion.


No Intervention: Control
Subject untrained.



Primary Outcome Measures :
  1. strength [ Time Frame: "pre" and "after" to "Baseline and 12 weeks" ]
    weight lifted in kg


Secondary Outcome Measures :
  1. Body composition [ Time Frame: "pre" and "after" to "Baseline and 12 weeks" ]
    kilogram (kg)



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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

After agreeing to participate in the study, patients will be interviewed and so they can be included, must meet the following criteria:

  • be seropositive for HIV / AIDS and not pregnant;
  • Present picture of SL;
  • Aged 30-60 years (both male and female);
  • Using ART, with unchanged medication in the last six months;
  • With stable body weight (less than 10% change in the last six months) (DOS SANTOS, WLALDEMIR ROBERTO et al, 2013.);
  • Do not present Peripheral Arterial Disease, determined by the ankle / brachial index (ABI) of less than 0.91 or greater than 1.30 (Giollo Junior, 2010);
  • Who are not engaged in systematic programs of physical exercise for at least three months;
  • What express voluntary agreement by signing the Informed Consent and Informed (IC).

Exclusion Criteria:

They will be excluded from the study patients who:

  • have any symptoms that indicate to their stay in the training program, or arising risks by doing exercises;
  • miss more than six (06) training sessions not consecutively (> 15% of the sessions) (Smart et al 2014.);
  • Present framework hypertensive (blood pressure greater than 140/90 mmHg from home) during the program (Noble, 2010; NHS, 2011; MANINI et al, 2012.);
  • Pass the present high risk factors for thromboembolism (MOTYKIE et al., 2000; CAPRINI, 2005); CD4 + lower levels than 200 cells / mm3 (SAIF; BONA; GREENBERG, 2001; Klein et al., 2005; CRUM-Cianflone; Weekes; BAVARO, 2008; SILVA; MORI; Guimarães, 2012), and high viral load, greater than 100,000 RNA copies / mL (CRUM-Cianflone; Weekes; BAVARO, 2008; SILVA; MORI; Guimarães, 2012); concurrent diseases classified as (1) infection (Mycobacterium avium, cytomegalovirus, Pneumocystis carinii pneumonia, the herpes simplex virus, Tuberculosis, Toxoplasmosis); (2) neoplasms (Kaposi's sarcoma, non-Hodgkin's lymphoma, Hodgkin's lymphoma), (3) autoimmune diseases (Hemolytic Anemia Autoimmune - (SAIF; BONA; GREENBERG, 2001); and (5) Ischemic Heart Disease, Aortic Stenosis Severe Obstructive Hypertrophic Cardiomyopathy and (Nakajima et al., 2006).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02783417


Locations
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Brazil
USP
Ribeirão Preto, São Paulo, Brazil, 14040-900
Sponsors and Collaborators
University of Sao Paulo

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Responsible Party: THIAGO CÂNDIDO ALVES, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02783417     History of Changes
Other Study ID Numbers: 44195315.6.0000.5393
First Posted: May 26, 2016    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by THIAGO CÂNDIDO ALVES, University of Sao Paulo:
Visceral fat
Additional relevant MeSH terms:
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Cardiovascular Diseases