NCT05798975

Brief Summary

Systemic arterial hypertension (SAH) is a multifactorial clinical condition, characterized by sustained elevation of blood pressure levels, contributing to 50% of deaths from cardiovascular disease. The Autonomic Nervous System (ANS) plays a fundamental role in the regulation of Blood Pressure (BP) and is closely associated with Heart Rate (HR). HR changes are called Heart Rate Variability (HRV). In individuals with SAH, HRV indices are reduced compared to normotensive individuals, showing changes in autonomic modulation, thus increasing the risk for cardiovascular events. The objective of this study will be to analyze the Heart Rate Variability in individuals with controlled SAH after a session of aerobic (EA) or resistance (RE) physical exercise.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 5, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

2.5 years

First QC Date

February 10, 2023

Last Update Submit

May 12, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Heart Rate Variability.

    Analysis of heart rate variability with Wincardio Digital ECG.

    4 hours

Study Arms (3)

Aerobic Physical Exercise

EXPERIMENTAL

Cycle ergometer exercise

Other: Resistance Exercise. 1 session of acute exerciseOther: no exercise

Resistance Physical Exercise

EXPERIMENTAL

Exercise with weights

Other: Aerobic Exercise. 1 session of acute exerciseOther: no exercise

Control

NO INTERVENTION

No exercise. Rest

Interventions

40 minutes on cycle ergometer, 60% of heart rate reserve

Resistance Physical Exercise

2 exercises for lower limbs and 2 for upper limbs with 4 sets of 12 repetitions at 60% 1-RM. 40 minutes

Aerobic Physical Exercise

Rest

Aerobic Physical ExerciseResistance Physical Exercise

Eligibility Criteria

Age30 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Controlled Systemic Alterial Hypertension

You may not qualify if:

  • Diabetes mellitus;
  • heart failure;
  • coronary artery disease;
  • chronic renal failure;
  • body mass index (BMI) ≥ 35 kg/m2;
  • smokers;
  • individuals with injuries to the upper and lower limbs that make the exercise protocol impossible;
  • not using antihypertensive medication and using beta-blocker and/or alpha-blocker medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diego Silveira da Silva

Porto Alegre, Rio Grande do Sul, Brazil

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: AE= Aerobic Exercise RE= Resistance Exercise CT= Control (no exercise)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physical education professor.

Study Record Dates

First Submitted

February 10, 2023

First Posted

April 5, 2023

Study Start

April 1, 2022

Primary Completion

October 1, 2024

Study Completion

November 30, 2024

Last Updated

May 14, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations