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Completed

NCT Number: NCT03879993

Resistance Training in People Living With HIV/AIDS

The aim of this study will be to verify effects of resistance training in people living with HIV/AIDS.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Behavior Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Motor Activity RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

State University of Maringá

Maringá, Paraná, Brazil

About this study

The aim of this study was verify effects of resistance training in cognitive function, body composition and biochemical parameters of inflammation and oxidative stress in people living with HIV/AIDS. The sample was composed by patients with HIV/AIDS of both sexes. The patients were randomized in two groups, a exercise group (EG), which was receive intervention with eight weeks of resistance training, and a control group (CG), that was not to do exercise. The cognitive function was analyzed with Stroop Test and Trail Test; body composition was evaluated by bioimpedance; blood tests was use to analyze biochemical parameters of inflammation and oxidative stress. For statistical analysis was used ANOVA of two factors for repeated measurements, having the (EG and PG) group and the time (pre and post exercise). Level of significance adopted was P < 0,05.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnostic for HIV/AIDS.
  • Clinical condition and viral count stabilized.
  • Have been using (HAART) for 6 months or more.
  • Not have participated in physical exercise programs in six months before beginning of study.
  • Not have muscle or joint injuries that make it impossible to practice physical activity.
  • Not be pregnant.

Exclusion criteria

  • Not attending more than 15% of the intervention sessions or visits to the laboratory.
  • Aggravation of the disease.
  • Stick to a physical activity program in addition to that offered by the study.

Treatment and study plan

Exercise group

Other

Resistance training 3 times per week (45-60 minutes of resistance training)

Other names: Training group

Primary outcomes

  1. Change in Cognitive Function

    Time frame: Baseline and eight weeks

    Victoria Stroop, Castro Cunha & Martins Stroop and Trail Test were performed at baseline and after eight weeks of intervention in both groups (EG and CG). Blood will be collected and brain-derived neurotrophic factor (BDNF) will be measured by Enzyme-Linked Immunosorbent Assay Method (Human - ELISA Kit) at baseline and after eight weeks of intervention in both groups (EG and CG).

Secondary outcomes

  1. CD4 / CD8

    Time frame: Baseline and eight weeks

    Blood was collected and cluster of differentiation 4 (T CD4+) and cluster of differentiation 8 (T CD8+) cells was measured by flow cytometry (BD TrucountTM Tubes) with FACSCalibur (Dickinson, New Jersey, USA) at baseline and after eight weeks of intervention in both groups (EG and CG).

  2. Concentration of Inflammatory markers

    Time frame: Baseline and eight weeks

    Blood was collected and interferon (INF-y), interleukin 4 (IL-4), interleukin 6 (IL-6) and interleukin 10 (IL-10) was be measured by Enzyme-Linked Immunosorbent Assay Method (Human - ELISA Kit) at baseline and after eight weeks of intervention in both groups (EG and CG).

  3. Health cellular

    Time frame: Baseline and eight weeks

    Cellular health was evaluated through phase angle value using the bio-electrical bioimpedance method (Biodynamics 450 analyzer, Biodynamics Corporation, Seattle, USA) at baseline and after eight weeks of intervention in both groups (EG and CG).

Other outcomes

  1. Change in body composition

    Time frame: Baseline and eight weeks

    Body composition was evaluated at baseline and after eight weeks of intervention in both groups (EG and CG) using thickness of skin folds (Lange Adipometer). The skin folds of the triceps, subscapular, supra iliac, abdominal, thigh and leg were collected. The data were inserted into formulas appropriate to the population studied for calculating body composition.

  2. Change in body circumferences

    Time frame: Baseline and eight weeks

    Perimeters of arms, chest, abdomen, waist, hip, thigh and leg were measured at baseline and after eight weeks of intervention in both groups (EG and CG).

  3. Change brachial blood pressure

    Time frame: Baseline and eight weeks

    Brachial blood pressure (systolic and diastolic pressures) was assessed through an automatic monitor (HEM-742, Omron Healthcare, Japan) at baseline and after eight weeks of intervention in both groups (EG and CG).

  4. Change autonomic cardiac modulation

    Time frame: Baseline and eight weeks

    The autonomic cardiac modulation was evaluated through a heart rate monitor (Polar, model RS-800, USA) at baseline and after eight weeks of intervention in both groups (EG and CG).

  5. Change in handgrip strength

    Time frame: Baseline and eight weeks

    Handgrip strength was evaluated by handgrip dynamometer at baseline and after eight weeks of intervention in both groups (EG and CG).

  6. Change in flexibility

    Time frame: Baseline and eight weeks

    Flexibility was evaluated by sit and reach test at baseline and after eight weeks of intervention in both groups (EG and CG).

  7. Training load control

    Time frame: Baseline and eight weeks

    Training load control was done by weekly monitoring and adjustment of the weights (kg) used in each exercise.

Sponsors and collaborators

Lead sponsor

State University of Maringá

Other

Registry information

Official study title

Effects of Resistance Training in People Living With HIV/AIDS

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Mar 19, 2019
Registry last updated
Mar 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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