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Completed

NCT Number: NCT05135247

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

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Key information

Conditions

Autonomic Dysfunction Autonomic Nervous System Diseases Cardiovascular Diseases Hypertension Nervous System Diseases Primary Dysautonomias Vascular Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

3 different types of training or control

Primary outcomes

  1. Heart rate

    Time frame: 12 weeks

    Heart rate was obtained before and after the protocol by electrocardiogram, performed before and after tilt test at each time.

  2. Low frequency band

    Time frame: 12 weeks

    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.

  3. High frequency band

    Time frame: 12 weeks

    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.

  4. Entropy

    Time frame: 12 weeks

    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.

  5. Short term detrended fluctuation analysis

    Time frame: 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 26, 2021
Registry last updated
Nov 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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