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Resistance Training in People Living With HIV/AIDS

Primary Purpose

HIV/AIDS

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Exercise group
Sponsored by
State University of Maringá
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV/AIDS focused on measuring Exercise, Cognition, Body composition, Inflammatory biomarkers, CD4

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • State University of Maringá

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise group

Control group

Arm Description

Exercise group was resistance training three times per week, during 45 to 60 minutes per day. Training program was composed by bench press, leg press 45°, lat pulldown, knee extension, dumbbell lateral raise, horizontal leg curl, triceps pulldown, seated calf raise, biceps curls and abdominal. Participants should complete 3 series with 8-12 repetitions of each exercise, which was supervised by trained research personnel. There were 60 seconds of interval between series and exercises were separated by a 120 seconds recovery period.

Control group was not do any exercise during intervention period. Participants was asked to keep their habitual routine until finish the final evaluations.

Outcomes

Primary Outcome Measures

Change in Cognitive Function
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 Outcome Measures

CD4 / CD8
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).
Concentration of Inflammatory markers
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).
Health cellular
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).

Full Information

First Posted
March 12, 2019
Last Updated
March 18, 2019
Sponsor
State University of Maringá
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1. Study Identification

Unique Protocol Identification Number
NCT03879993
Brief Title
Resistance Training in People Living With HIV/AIDS
Official Title
Effects of Resistance Training in People Living With HIV/AIDS
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
February 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of Maringá

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
Keywords
Exercise, Cognition, Body composition, Inflammatory biomarkers, CD4

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Blood collections and subsequent analyzes were done blindly.
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise group
Arm Type
Experimental
Arm Description
Exercise group was resistance training three times per week, during 45 to 60 minutes per day. Training program was composed by bench press, leg press 45°, lat pulldown, knee extension, dumbbell lateral raise, horizontal leg curl, triceps pulldown, seated calf raise, biceps curls and abdominal. Participants should complete 3 series with 8-12 repetitions of each exercise, which was supervised by trained research personnel. There were 60 seconds of interval between series and exercises were separated by a 120 seconds recovery period.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group was not do any exercise during intervention period. Participants was asked to keep their habitual routine until finish the final evaluations.
Intervention Type
Other
Intervention Name(s)
Exercise group
Other Intervention Name(s)
Training group
Intervention Description
Resistance training 3 times per week (45-60 minutes of resistance training)
Primary Outcome Measure Information:
Title
Change in Cognitive Function
Description
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).
Time Frame
Baseline and eight weeks
Secondary Outcome Measure Information:
Title
CD4 / CD8
Description
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).
Time Frame
Baseline and eight weeks
Title
Concentration of Inflammatory markers
Description
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).
Time Frame
Baseline and eight weeks
Title
Health cellular
Description
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).
Time Frame
Baseline and eight weeks
Other Pre-specified Outcome Measures:
Title
Change in body composition
Description
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.
Time Frame
Baseline and eight weeks
Title
Change in body circumferences
Description
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).
Time Frame
Baseline and eight weeks
Title
Change brachial blood pressure
Description
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).
Time Frame
Baseline and eight weeks
Title
Change autonomic cardiac modulation
Description
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).
Time Frame
Baseline and eight weeks
Title
Change in handgrip strength
Description
Handgrip strength was evaluated by handgrip dynamometer at baseline and after eight weeks of intervention in both groups (EG and CG).
Time Frame
Baseline and eight weeks
Title
Change in flexibility
Description
Flexibility was evaluated by sit and reach test at baseline and after eight weeks of intervention in both groups (EG and CG).
Time Frame
Baseline and eight weeks
Title
Training load control
Description
Training load control was done by weekly monitoring and adjustment of the weights (kg) used in each exercise.
Time Frame
Baseline and eight weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ademar Avelar, PhD
Organizational Affiliation
State University of Maringá
Official's Role
Principal Investigator
Facility Information:
Facility Name
State University of Maringá
City
Maringá
State/Province
PR
Country
Brazil

12. IPD Sharing Statement

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Resistance Training in People Living With HIV/AIDS

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