跳至主要内容
临床试验/NCT02783417
NCT02783417终止不适用

Impact of Strength Training With Vascular Occlusion on the Syndrome Lipodystrophy in Patients Harboring With HIV/Aids

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2015年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
22
试验地点
2
主要终点
strength

研究概览

简要总结

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.

详细描述

METHODOLOGY Type of Study It is a study of the experimental type with equivalent control groups.

Sample A convenience sample will consist of approximately 60 patients seropositive for HIV / AIDS, in use of ART. Patients will be invited between routine visits in the clinic at the Special Unit for Treatment of Infectious Diseases (UETDI) of the Hospital of the Ribeirão Preto Medical School, University of São Paulo (USP HCFMRP-). They will be invited to participate voluntarily, provided that (initially) are considered eligible to participate in the study, later confirmed by medical clearance to practice physical exercises.

Place of conducting the survey:

The study will be conducted in the Orientation and Education Center of Adult and Elderly (House 5) of the Ribeirão Preto School of Nursing, University of São Paulo (EERP / USP) and UETDI HCFMRP-USP.

Lipodystrophy Syndrome (SL) The diagnosis for SL will be determined by clinical examination upon patients' reports of fat loss in the limbs, buttocks and face, with or without fat accumulation in the trunk, waist, breasts - gynecomastia (men) and cervical back, clinically confirmed by a trained professional as previously described.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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).

研究组 & 干预措施

Training with vascular occlusion

Experimental

Strength Training: intensity of 30% of 1RM, with vascular occlusion pressure in members.

干预措施: Strength Training (Other)

Traditional strength training

Experimental

Strength Training: intensity of 80% of 1RM, without vascular occlusion pressure in members

干预措施: Strength Training (Other)

Control

No Intervention

Subject untrained.

结局指标

主要结局

strength

时间窗: "pre" and "after" to "Baseline and 12 weeks"

weight lifted in kg

次要结局

  • Body composition("pre" and "after" to "Baseline and 12 weeks")

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

THIAGO CÂNDIDO ALVES

Principal Investigator

University of Sao Paulo

研究点 (2)

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