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Effect of electrical stimulation applied to the left ear associated with physical training on a bicycle in people with high blood pressure

Effects of Noninvasive Vagus Nerve Stimulation and Aerobic Exercise on Blood Pressure, Cardiac Autonomic Modulation, Inflammation and Functional Capacity in Hypertensive Patients: a controlled, randomized, blinded clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3s6fk6j
Enrollment
Unknown
Registered
2024-11-12
Start date
2024-11-01
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

Hypertension

Interventions

This is a three-arm, blinded, randomized controlled clinical study. Seventeen volunteers in the experimental group will receive vagus nerve stimulation associated with physical exercise, seventeen vol
30 minutes of exercise on an exercise bike at moderate intensity between 50% and 60% of their maximum heart rate reserve, estimated at 220 minus the participa
G11.427.410.698.277

Sponsors

Associação Educacional Nove de Julho
Lead Sponsor
Associação Educacional Nove de Julho
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Individuals of both genders diagnosed with mild to moderate hypertension (Stages I and II); over 18 years of age; who use a maximum of 3 classes of drugs; hypertensive individuals with systolic blood pressure (SBP) levels of 140 to 160 mmHg and diastolic blood pressure (DBP) of 90 to 100 mmHg; hypertensive individuals physically fit to perform exercises and with medical clearance for the activity

Exclusion criteria

Exclusion criteria: Individuals with contraindications for the use of vagus nerve stimulation (cochlear implant, metals or skin lesions at the application site); Individuals with a history of ischemic stroke, coronary disease, chronic obstructive or restrictive pulmonary disease, peripheral arterial disease, hyper or hypothyroidism, chronic atrial fibrillation, Diabetes Mellitus, immunodependent, chronic kidney disease on dialysis; Individuals using antihypertensives (beta blockers); pregnant women; Individuals with cardiac pacemakers; Individuals who do not complete all training and who do not perform post-intervention evaluations will be excluded from the final analysis

Design outcomes

Primary

MeasureTime frame
It is expected that transcutaneous auricular vagus nerve stimulation combined with physical exercise will reduce clinical systolic and diastolic blood pressure in hypertensive individuals much more than transcutaneous auricular vagus nerve stimulation alone or physical exercise alone

Secondary

MeasureTime frame
It is expected that transcutaneous auricular vagus nerve stimulation associated with physical exercise will significantly improve blood pressure measured by ambulatory blood pressure monitoring (ABPM) in hypertensive individuals than transcutaneous auricular vagus nerve stimulation alone or physical exercise alone;It is expected that transcutaneous auricular vagus nerve stimulation associated with physical exercise will decrease the levels of inflammatory markers Interleukin 1-beta (IL-1ß); Interleukin 6 (IL-6); Interleukin 10 (IL-10); Tumor Necrosis Factor Alpha (TNF-a) much more than transcutaneous auricular vagus nerve stimulation alone or physical exercise alone;It is expected that transcutaneous auricular vagus nerve stimulation associated with physical exercise will significantly reduce the levels of oxidative stress markers Hydrogen Peroxide, NADPH oxidase, Catalase (CAT), Superoxide Dismutase (SOD), Iron Reducing Antioxidant Power (FRAP), Thiobarbituric Acid Reactive Substances (TBARS), carbonyls and nitrites than transcutaneous auricular vagus nerve stimulation alone or physical exercise alone;It is expected that transcutaneous auricular vagus nerve stimulation associated with physical exercise will improve cardiac autonomic modulation in hypertensive individuals much more than transcutaneous auricular vagus nerve stimulation alone or physical exercise alone;It is expected that transcutaneous auricular vagus nerve stimulation associated with physical exercise will improve the functional capacity of hypertensive individuals much more than transcutaneous auricular vagus nerve stimulation alone or physical exercise alone

Countries

Brazil

Contacts

Public ContactFernanda Corrêa

Universidade Nove de Julho - UNINOVE

fecorrea@uni9.pro.br+55 (11) 2633-9000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)