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Effect of vagus nerve stimulation and physical exercise on cardiovascular, metabolic and cognitive responses in people with HIV

Effect of Auricular Transcutaneous Electrostimulation of the Vague Nerve and Physical Exercise on the cardiovascular, metabolic and cognitive parameters of people living with HIV / AIDS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8k54cz
Enrollment
Unknown
Registered
2020-07-09
Start date
2019-12-02
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Interventions

The sample will consist of 60 volunteers, equally divided into 2 groups: 1) TAVNS Physical Exercise
2) Sham-t physical exercise (inactive stimulation of the taVNS). The stimulation sessions will last for 30 minutes, in 3 days with 48h intervals, for 12 weeks. A TENS device (Tens Fes Clinico 2 Channe
2-3 series
intensity of 8-12 maximum repetitions
90s interval between sets and 120s between exercises
and cadence ranging from 3-5 seconds.
Device
Behavioural
G11.427.410.698.277

Sponsors

Universidade Federal do Rio Grande do Norte
Lead Sponsor
Universidade Federal do Rio Grande do Norte
Collaborator

Eligibility

Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Individuals will need to present a medical certificate clearing the practice of physical exercise, be aged between 18-60 years, present a number of TCD4 lymphocyte cells equal to or above 350 cells / mm³ of blood and enroll as participants in the “VIVER +” project.

Exclusion criteria

Exclusion criteria: Individuals who do not have conditions to carry out the protocol and the evaluations during the research, have opportunistic injuries or infections, have undergone cardiac surgery or have heart disease, are currently dependent on illicit drugs, have serious medical disorders and / or have less than 75% will be excluded. attendance at physical exercise sessions.

Design outcomes

Primary

MeasureTime frame
Improved cardiac autonomic control at rest with increased parasympathetic activity, assessed through heart rate variability, using a Polar H10 heart rate transmitter in conjunction with the Elite HRV smartphone app, before and after the initial 12 weeks and before and after 12 final weeks

Secondary

MeasureTime frame
better postural control, will be evaluated using a CEFISE force platform before and after the initial 12 weeks and before and after the final 12 weeks.;Greater heart rate recovery after a 6-minute walk test, measured using Polar's H10 heart rate transmitter along with the Elite HRV smartphone app, before and after the initial 12 weeks and before and after the final 12 weeks.;improvement of body composition, with an increase in muscle mass and a reduction in the percentage of fat, which will be assessed using Dual Energy Radiological Absortometry (DEXA) using the Lunar Prodigy Bone Densitometry device, before and after the initial 12 weeks and before and after the final 12 weeks.;Higher oxygen consumption and a more controlled energy expenditure during rest, using substrates through fat to obtain energy, these variables will be evaluated by the motorized treadmill stress test (Centuriom 300, Brasília-DF, Brazil) following a protocol of individualized ramp, in addition, the assessment of resting metabolism will also be made. Ventilatory variables will be measured by a metabolic gas analyzer (Metalyzer 3B-MICROMED model), before and after the initial 12 weeks and before and after the final 12 weeks.;Greater control of serum levels of biochemical markers, which will be evaluated for fasting blood glucose and insulin, lipid profile (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides), inflammatory markers (IL1; IL6; TNF; And PCR), factor marker neurotrophic (BDNF) and hormonal profile (cortisol, adrenaline and noradrenaline), before and after the initial 12 weeks and before and after the final 12 weeks. ;Better cognitive response through the evaluation of cognitive parameters, which will be measured the executive functions where they will be evaluated through the Stroop test of Colors and Words; Cognitive flexibility: through the Trail Making Test; Visomotor attention and dexterity: through the test of replacing digits with symbols (WAIS-IV); Praxis and

Countries

Brazil

Contacts

Public ContactPhelipe Varela

Universidade Federal do Rio Grande do Norte

phelipewilde97@hotmail.com+55-84-999628109

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 3, 2026