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CompletedNCT05135247Updated Nov 26, 2021

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

An interventional study of Exercise in Autonomic Dysfunction, sponsored by University of Sao Paulo. Completed. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-26.

Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 years 9 months after the study started (first participant enrolled Jan 2015, registered Nov 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
61
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study summary

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

Read the 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)
02

Conditions studied

  • Autonomic Dysfunction

Keywords

  • older individuals
  • heart rate variability
  • physical training
  • hypertension
03

In context

Autonomic Nervous System Diseases

166 studies on the registry are indexed under Autonomic Nervous System Diseases; 36 are open to participants now.

This study's enrollment of 61 is above the median of 40 across 107 interventional studies indexed under Autonomic Nervous System Diseases.

Browse Autonomic Nervous System Diseases studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
61 participants (actual)

Study arms

  • Experimental
    continuous aerobic training (CA)

    The CA group was trained with 70% of maximum heart rate (MHR) for 30 minutes.

    Other: Exercise

  • 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

  • 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

  • No intervention
    control (C)

    Individuals in the control group maintained their usual activities.

Interventions

  • OtherExercise

    3 different types of training or control

06

What researchers measure

Primary outcomes

  1. Heart rate

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

    Time frame: 12 weeks

  2. 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.

    Time frame: 12 weeks

  3. 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.

    Time frame: 12 weeks

  4. 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.

    Time frame: 12 weeks

  5. 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.

    Time frame: 12 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — Individual data of volunteers, without identification, can be provided if requested by other authors, through contact with the main researcher

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05135247
Lead sponsor
University of Sao Paulo
Responsible party
Nereida Kilza da Costa Lima (Associated Professor, University of Sao Paulo) — Principal investigator
First posted
Nov 26, 2021
Start date
Jan 10, 2015
Primary completion
Jun 10, 2017
Completion
Jul 10, 2017
Last update
Nov 26, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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