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Effects of Neuromodulation on Blood Pressure of hypertenses submitted to Physical Exercise

Effects of Neuromodulation of insular cortex on Blood Pressure of hypertenses submitted to Aerobic Exercise

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-56jg3n
Enrollment
Unknown
Registered
2019-03-26
Start date
2020-01-13
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

Twenty individuals will be randomized (1:1) and assigned to the hypertensive group (active group: GA) who will perform moderate-intensity aerobic physical exercises and will receive transcranial direc
Device
E02.331.750
G11.427.410.698.277

Sponsors

Universidade Federal da Paraíba
Lead Sponsor
Instituto de Educação Superior da Paraíba - IESP
Collaborator

Eligibility

Age
No minimum to 65 Years

Inclusion criteria

Inclusion criteria: Men and women aged between 18-65 years diagnosed with arterial hypertension (systolic blood pressure greater than 130 and less than 180 mmHg or diastolic greater than 85 and less than 120 mmHg) will be included.

Exclusion criteria

Exclusion criteria: Participants will be excluded if they present a diagnosis of resistant hypertension; history of hematological diseases; neurological diseases; peripheral vascular diseases; stroke; consume more than 30g of alcohol per day; be doing any hormone replacement therapy; have a body mass index greater than 30 kg m²; have cognitive problems that make it impossible to execute commands; present physical limitations that prevent the accomplishment of the exercise protocol; have a dissecting aneurysm and miss more than 3 sessions continuously or lack at least 30% of the stimulation and physical exercise protocol.

Design outcomes

Primary

MeasureTime frame
The primary outcome will be the Blood Pressure that will be evaluated by different methods and presented in milimiters of mercury (mmHg). In this way, we will use Ambulatory Blood Pressure Monitoring (MAPA, Dyna MAPA CARDIOS, Brazil) to evaluate the physiological behavior of Blood Pressure during 24 hours through a cuff placed on the non-dominant arm connected to a belt that will contain the MAPA equipment. The entire procedure of Blood Pressure collection in the 24 hours will follow the recommendations of the European Society of Hypertension Practice Guidelines for home Blood Pressure monitoring (Parati et al., 2010). Other method used to collect Blood Pressure will be the oscillometric, which will use the Finometer (Finapress Medical Systems BV, model 1, Amsterdam, The Netherlands), which provides the Blood Pressure signal continuously and non-invasively, and therefore, it will be used to evaluate vascular autonomic control (sympathetic vasomotor modulation and spontaneous baroreflex sensitivity). The Blood Pressure signal will be recorded for 10 minutes in the DATAQ/WINDAQ DI 200 Program, at a sampling frequency of 1000Hz, and stored in a computer for later analysis. To acquire this Blood Pressure signal, subjects will be in a supine position with the cuff placed on the non-dominant arm. The third method will be the DIXTAL automatic oscillometric (DX 2020; Manaus, Brazil), which will provide the Blood Pressure values that will later be used to calculate the peripheral vascular resistance. The Blood Pressure measurement per minute will be obtained, and Blood Pressure values will be included in an individual form. To acquire these Blood Pressure values, the subjects will be in the supine position with the cuff placed on one of the lower limbs. We hope that the interventions reduce Blood Pressure greater than 2 mmHg in the active group compared to sham (the measures will be carried out 1 week before the interventions, after the first intervention and after 1 and/or

Secondary

MeasureTime frame
Muscle Blood Flow and Peripheral Vascular Resistance will be measured through verification of forearm blood flow performed using the venous occlusion plethysmography technique. A mercury-filled silastic tube connected to a low-pressure transducer, fixed around the forearm, 5 cm distal to the humeral-radial joint and connected to the plethysmograph (Hokanson / EC6 pletymograph) will be used. One cuff will be placed around the wrist and another on the upper arm. The wrist cuff will be inflated to a supra-systolic level 1 minute before the measurements are initiated. At 10-second intervals, the arm cuff will be inflated above the venous pressure for a period of 10 seconds, totaling 3 cycles / waves per minute. The increase in tension in the silastic tube will reflect the increase in forearm volume and, consequently, vasodilation. The signal of the muscle flow wave will be acquired on-line in a computer through the program WINDAQ DI-200, in the frequency of 500Hz. Vascular resistance will be calculated by the ratio of mean arterial pressure (mmHg) and forearm blood flow (ml / min / 100ml). We expect blood flow to increase and resistance decrease significantly in the active group compared to sham after interventions (the measures will be carried out 1 week before the interventions, after the first intervention and after 1 and/or 2 months of interventions).;Vasomotor variability will be obtained through the Blood Pressure (mmHg) signal through the Finometer, which will be used to generate the time series of systolic blood pressure (sistogram) and diastolic blood pressure (diastogram), later, the sistogram and diastogram will be used to obtain the power spectra. The components of the low-frequency band (0.03-0.15 Hz) of systolic blood pressure and diastolic blood pressure will be used as vascular sympathetic modulation index. We expect to decrease sympathetic activity significantly in the active group compared to sham after interventions (the measures will be carried out 1

Countries

Brazil

Contacts

Public ContactEdson;Maria Silva Filho;Brasileiro Santos

Universidade Federal da Paraíba;Universidade Federal da Paraíba

meneses.edson@yahoo.com.br;sbrasileiro@yahoo.com.br+55-081994706661;+55-083982027067

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 6, 2026