NCT02783417

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 26, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

November 1, 2017

Status Verified

October 1, 2017

Enrollment Period

1.5 years

First QC Date

May 18, 2016

Last Update Submit

October 30, 2017

Conditions

Keywords

Visceral fat

Outcome Measures

Primary Outcomes (1)

  • strength

    weight lifted in kg

    "pre" and "after" to "Baseline and 12 weeks"

Secondary Outcomes (1)

  • Body composition

    "pre" and "after" to "Baseline and 12 weeks"

Study Arms (3)

Training with vascular occlusion

EXPERIMENTAL

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

Other: Strength Training

Traditional strength training

EXPERIMENTAL

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

Other: Strength Training

Control

NO INTERVENTION

Subject untrained.

Interventions

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.

Traditional strength trainingTraining with vascular occlusion

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USP

Ribeirão Preto, São Paulo, 14040-900, Brazil

Location

Related Publications (2)

  • Alves TC, Pugliesi Abdalla P, Bohn L, Da Silva LSL, Dos Santos AP, Tasinafo Junior MF, Rossini Venturini AC, Mota J, Lopes Machado DR. Acute and chronic cardiometabolic responses induced by resistance training with blood flow restriction in HIV patients. Sci Rep. 2022 Oct 10;12(1):16989. doi: 10.1038/s41598-022-19857-3.

  • Alves TC, Santos AP, Abdalla PP, Venturini ACR, Angelotti PS, Borges FG, Reis HDO, Bollela VR, Mota J, Machado DRL. Resistance training with blood flow restriction: Impact on the muscle strength and body composition in people living with HIV/AIDS. Eur J Sport Sci. 2021 Mar;21(3):450-459. doi: 10.1080/17461391.2020.1757765. Epub 2020 May 14.

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Resistance Training with Blood Flow Restriction
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 18, 2016

First Posted

May 26, 2016

Study Start

August 1, 2015

Primary Completion

February 1, 2017

Study Completion

September 1, 2017

Last Updated

November 1, 2017

Record last verified: 2017-10

Locations