NCT04371757

Influence of the Autonomic Nervous System in Response to Exercise in Hypertensive Individuals

Status unknown NA Last updated 1 May 2020

What this trial tests

NA trial testing α1-adrenergic block in Autonomic Nervous System in 39 participants. Status unknown.

Timeline

30 April 2020

Primary endpoint
20 December 2020

23 December 2021

Quick facts

Lead sponsor	Instituto de Cardiologia do Rio Grande do Sul
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	39
Start date	30 April 2020
Primary completion	20 December 2020
Estimated completion	23 December 2021
Sites	1 location across Brazil

Drugs / interventions tested

• α1-adrenergic block — full drug profile →
• Placebo

Conditions studied

• Autonomic Nervous System — all drugs for Autonomic Nervous System →
• Hypertension — all drugs for Hypertension →

Sponsor

Instituto de Cardiologia do Rio Grande do Sul — full company profile →

Who can join

Adults 35 to 55, any sex, with Autonomic Nervous System or Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Systemic arterial hypertension (SAH) has a direct association with endothelial dysfunction and major cardiovascular events. Evidence points to possible benefits of aerobic training in the endothelial function analyzed by the flow mediated dilation technique (flow mediated dilatation - FMD) in individuals with SAH. However, little is known about the influence of the autonomic nervous system (ANS) on the results of brachial artery FMD after different types of acute exercise in individuals with SAH. Thus, the objective of the research is to analyze the influence of the ANS on the FMD of the brachial artery of individuals with SAH after a session of aerobic (EA), resistance (ER) and combined (EC) exercise. For this, thirty-nine hypertensive individuals aged 35 to 55 years will be recruited and will be randomized to 2 sessions of AS, ER or EC. Also, within each modality, they will be randomized to α1-adrenergic block (Doxazosin 0.05 mg / kg-1) or placebo. The FMD will be performed by ultrasound 10 minutes before, as well as 10, 40 and 70 minutes after the exercise sessions and the autonomic control will be monitored (Finometer) for 10 minutes before each FMD. Arterial stiffness will also be analyzed, using the pulse wave velocity (PWV) by the Complior Analyzer. It is expected to demonstrate with this research the influence of the ANS on the FMD of the brachial artery in individuals with SAH in different physical exercises. This knowledge contributes to a better training prescription in this population.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effects of autonomic nervous system activation on endothelial function in response to acute exercise in hypertensive individuals: study protocol for a randomized double-blind study.
   Waclawovsky G, Boll LFC, Neto SG, Irigoyen MCC, et al · · 2021 · cited 2× · PMID 34412668 · DOI 10.1186/s13063-021-05516-x
2. Effects of Autonomic Nervous System Activation on Endothelial Function in Response to Acute Exercise in Hypertensive Individuals: Study Protocol for A Randomized Double-Blind Study
   Waclawovsky G, Boll LF, Neto SG, Irigoyen MC, et al · · 2020 · DOI 10.21203/rs.3.rs-32356/v1