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

NCT04371757 | Unknown DMC

• 1 other identifier: Autonomic nervous system
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autonomic Nervous System; Hypertension

Keywords

Endothelium; Physical Exercise

Outcome Measures

Primary Outcomes (1)

• Changes in the endothelial function of hypertensive individuals after a session of aerobic exercise, resistance exercise and combined exercise in α1-adrenoreceptor blocker and placebo condition.

  The method of assessing the flow-mediated dilation (FMD) of the brachial artery by ultrasonography is an indirect method to assess endothelial function. To analyze the FMD of the brachial artery a rapid deflation cuff will be placed around the forearm 5 cm distal to the antecubital fossa and the image of the brachial artery will be obtained in the distal third of the arm. Baseline diameters will be recorded for 1 minute, before the forearm cuff is inflated at 50 mmHg above the SBP, for 5 minutes. The recording of the images will be resumed 30 seconds before the deflation of the cuff and maintained for 3 minutes after deflation. The video signal of the Doppler Ultrasound will be recorded in real time by a USB video card and saved for offline analysis. The analysis of diameter will be performed using edge detection and wall tracking software. The FMD will be calculated as the percentage change in the peak diameter after deflating the cuff from the baseline diameter.

  Ten minutes before the exercise session and 10, 40 and 70 minutes after the exercise session.

Study Arms (3)

Aerobic exercise session

EXPERIMENTAL

The aerobic exercise session will be performed on a horizontal cycle ergometer. A warm-up will be performed (5 minutes), followed by 40 minutes with moderate intensity (60% HRreserve) and controlled by a heart rate monitor, as well as the subjective effort scale (Borg 6 to 20 points). Blood pressure, heart rate and the Borg scale will be assessed at the beginning of aerobic exercise and every 5 minutes until the end.

Drug: α1-adrenergic block; Other: Placebo

Resistance exercise session

EXPERIMENTAL

The resistance exercise session will be structured with knee extension, knee flexion, leg pressure and plantar flexion, in a station with guided weights, with 4x12 repetitions and 60% intensity of 1-RM; the cadence will be adjusted to 2:2 (concentric: eccentric) and controlled by a metronome. The rest between sets and exercises will be 90 seconds (total duration: 40 minutes). Blood pressure, heart rate and Borg scale will be recorded at the beginning and at the end of the 4th series of each exercise.

Drug: α1-adrenergic block; Other: Placebo

Combined exercise session

EXPERIMENTAL

The combined exercise session will be structured with 20 minutes of resistance exercise + 20 minutes of aerobic exercise, as already described, except that the resistance exercises will have 2 sets of each exercise. As with other sessions, blood pressure, heart rate and the Borg scale will be assessed at the beginning and end of the second series of resistance exercise, as well as at the beginning and every 5 minutes of aerobic exercise up to 15 minutes after end of exercises.

Drug: α1-adrenergic block; Other: Placebo

Interventions

α1-adrenergic block DRUG

Ninety minutes before starting the experimental exercise protocol, participants will be offered a capsule containing an α-1 adrenoreceptor blocker (Drozazosin; 0.05 mg / kg-1 body weight) and will be instructed to lie down. All capsules will be handled by a specialized pharmacy.

Also known as: Doxazosin

Aerobic exercise session; Combined exercise session; Resistance exercise session

Placebo OTHER

Ninety minutes before starting the experimental exercise protocol, participants will be offered a capsule containing an placebo (microcrystalline cellulose; 0.05 mg.kg-1 body weight) and will be instructed to lie down. All capsules will be handled by a specialized pharmacy.

Also known as: Microcrystalline cellulose

Aerobic exercise session; Combined exercise session; Resistance exercise session

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical diagnosis of systemic arterial hypertension;
• Must be able to reality physical exercise.

You may not qualify if:

• Diabetes mellitus;
• Chronic renal failure;
• Body mass index ≥ 35kg/m2;
• Coronary artery disease;
• Heart failure;
• Use of beta-blocker;
• Uso of alpha-blocker;
• Smoker;
• Menopause (woman).

Sponsors & Collaborators

• Instituto de Cardiologia do Rio Grande do Sul: lead

Study Sites (1)

Gustavo Waclawovsky

Porto Alegre, Rio Grande do Sul, 90440-010, Brazil

RECRUITING

Related Publications (25)

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  PMID: 24277765 RESULT

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• Waclawovsky G, Boll LFC, Neto SG, Irigoyen MCC, Lehnen AM. 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. Trials. 2021 Aug 19;22(1):548. doi: 10.1186/s13063-021-05516-x.

  PMID: 34412668 DERIVED

MeSH Terms

Conditions

Hypertension; Motor Activity

Interventions

Doxazosin; microcrystalline cellulose

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Prazosin; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Gustavo Waclawovsky, PhD

CONTACT

555132354070; gwsaude@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The allocation secrecy will be maintained until the time of the experiments, through a randomization list, in a remote place and without direct access by the researchers.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization for exercise interventions, as well as placebo or α1-adrenergic, will be performed using a computer program containing the coded distribution. The randomization of the subjects will be characterized as simple and divided into two parts; (A) directed to the three arms of exercise (aerobica exercise, resistido exercise and combinade exercise) and (B) the order in relation to the placebo or α1-adrenergic block.

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: May 1, 2020
• Study Start: April 30, 2020
• Primary Completion: December 20, 2020
• Study Completion: December 23, 2021
• Last Updated: May 1, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)