Cardiac Autonomic Modulation in Older Hypertensive Individuals Submitted to Different Types of Physical Training

Sixty-one sedentary older hypertensive individuals were randomized to four groups: continuous aerobic training (CA), interval aerobic training (IA), resistance training (R), and control (C) group. The protocol included 3 sessions of training by week for 12 weeks. C individuals were instructed to continue their usual activities. They were submitted to the passive tilt test before and after the research protocol, evaluating the heart rate (HR), low frequency (LF) and high frequency (HF) bands, detrended fluctuation analysis (DFAα1) and entropy

Study Overview

• Status: Completed
• Conditions: Autonomic Dysfunction
• Intervention / Treatment: Other: Exercise

Detailed Description

The individuals were randomized into four groups: continuous aerobic training (CA), interval aerobic training (IA), resistance training (R), and control (C), which performed physical exercises three times a week for twelve weeks, with a total of 36 sessions. The tilt test was performed before and after the research protocol. Individuals in the control group were only encouraged to maintain their usual activities.

For the analysis of HRV, the baseline conditions (resting in the supine position) were determined, followed by the passive postural maneuver, which characterizes the tilt test (table til tat 70 °) in order to determine the following variables:

• HR: heart rate (sympathetic action)
• LF: Low frequency band (Modulated predominantly by the sympathetic system)
• HF: High frequency band (Modulated predominantly by the parasympathetic system)
• Entropy: data complexity or irregularity index showing that, the higher the values, the better the HRV.
• DFAα1 (short term detrended fluctuation analysis)

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:men and women 60-year-old or older, extensively using prescription antihypertensive drugs, and having no previous experience with physical training -

Exclusion Criteria:

• • Positive treadmill test (TT) for ischemia

  • Related left ventricular systolic dysfunction of any degree
  • Presence of arrhythmias
  • Use of β-blockers
  • Use more than seven doses of ethyl alcohol per week
  • Renal insufficiency
  • Diabetes
  • Hyper- or hypothyroidism
  • Limiting lung disease
  • Osteomioarticular impairment that would limit exercise performance
  • SBP ≥160 and/or DBP ≥ 100 mmHg on baseline

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: continuous aerobic training (CA); The CA group was trained with 70% of maximum heart rate (MHR) for 30 minutes.	Other: Exercise; 3 different types of training or control
EXPERIMENTAL: resistance training (R); The R sessions consisted of a set of each proposed exercise: sitting bench press, legpress, back row, leg extension, shoulders high pull, seated leg curl, biceps curls, standing calf, triceps in the pulley, and abdominal crunches, with 8 - 10 repetitions with 75% 1MR.	Other: Exercise; 3 different types of training or control
EXPERIMENTAL: interval aerobic training (IA); The IA group was submitted to exercise intensities of 60% for 2 minutes and 80% for 2 minutes, alternately, with a total of 30 minutes.	Other: Exercise; 3 different types of training or control
NO_INTERVENTION: control (C); Individuals in the control group maintained their usual activities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Heart rate was obtained before and after the protocol by electrocardiogram, performed before and after tilt test at each time.	12 weeks
Low frequency band	Low frequency band was obtained before and after the protocol by electrocardiogram, performed before and after tilt test at each time.The electrical signal from the electrocardiogram was filtered and amplified. The amplified signals were processed by ananalog-digital converter (DI-720, DATAQ Instruments, Akron, OH, USA) and sampled (1000 hz per channel) by a computer program (Windaq, DATAQ, Akron, OH, USA) installed in an IBM/PC computer.	12 weeks
High frequency band	High frequency band was obtained before and after the protocol by electrocardiogram, performed before and after tilt test at each time.The electrical signal from the electrocardiogram was filtered and amplified. The amplified signals were processed by ananalog-digital converter (DI-720, DATAQ Instruments, Akron, OH, USA) and sampled (1000 hz per channel) by a computer program (Windaq, DATAQ, Akron, OH, USA) installed in an IBM/PC computer.	12 weeks
Entropy	Entropy was obtained before and after the protocol by electrocardiogram, performed before and after tilt test at each time.The electrical signal from the electrocardiogram was filtered and amplified. The amplified signals were processed by ananalog-digital converter (DI-720, DATAQ Instruments, Akron, OH, USA) and sampled (1000 hz per channel) by a computer program (Windaq, DATAQ, Akron, OH, USA) installed in an IBM/PC computer.	12 weeks
Short term detrended fluctuation analysis	Short term detrended fluctuation analysis obtained before and after the protocol by electrocardiogram, performed before and after tilt test at each time.The electrical signal from the electrocardiogram was filtered and amplified. The amplified signals were processed by ananalog-digital converter (DI-720, DATAQ Instruments, Akron, OH, USA) and sampled (1000 hz per channel) by a computer program (Windaq, DATAQ, Akron, OH, USA) installed in an IBM/PC computer.	12 weeks

Collaborators and Investigators

• Sponsor: University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 10, 2015
• Primary Completion (ACTUAL): June 10, 2017
• Study Completion (ACTUAL): July 10, 2017

Study Registration Dates

• First Submitted: November 9, 2021
• First Submitted That Met QC Criteria: November 19, 2021
• First Posted (ACTUAL): November 26, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 26, 2021
• Last Update Submitted That Met QC Criteria: November 19, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: hypertension; heart rate variability; physical training; older individuals
• Additional Relevant MeSH Terms: Nervous System Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases
• Other Study ID Numbers: 1.092.824

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual data of volunteers, without identification, can be provided if requested by other authors, through contact with the main researcher
• IPD Sharing Time Frame: Data will be made available after the publication of the study, with no time to end sharing
• IPD Sharing Access Criteria: contact with the main researcher
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No