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

Primary Purpose

Autonomic Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autonomic Dysfunction focused on measuring older individuals, heart rate variability, physical training, hypertension

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    No Intervention

    Arm Label

    continuous aerobic training (CA)

    resistance training (R)

    interval aerobic training (IA)

    control (C)

    Arm Description

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

    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.

    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.

    Individuals in the control group maintained their usual activities.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    November 9, 2021
    Last Updated
    November 19, 2021
    Sponsor
    University of Sao Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05135247
    Brief Title
    Cardiac Autonomic Modulation in Older Hypertensive Individuals Submitted to Different Types of Physical Training
    Official Title
    Cardiac Autonomic Modulation in Older Hypertensive Individuals Submitted to Different Types of Physical Training
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 10, 2015 (Actual)
    Primary Completion Date
    June 10, 2017 (Actual)
    Study Completion Date
    July 10, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Sao Paulo

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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
    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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Autonomic Dysfunction
    Keywords
    older individuals, heart rate variability, physical training, hypertension

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model 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.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    61 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    continuous aerobic training (CA)
    Arm Type
    Experimental
    Arm Description
    The CA group was trained with 70% of maximum heart rate (MHR) for 30 minutes.
    Arm Title
    resistance training (R)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    interval aerobic training (IA)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    control (C)
    Arm Type
    No Intervention
    Arm Description
    Individuals in the control group maintained their usual activities.
    Intervention Type
    Other
    Intervention Name(s)
    Exercise
    Intervention Description
    3 different types of training or control
    Primary Outcome Measure Information:
    Title
    Heart rate
    Description
    Heart rate was obtained before and after the protocol by electrocardiogram, performed before and after tilt test at each time.
    Time Frame
    12 weeks
    Title
    Low frequency band
    Description
    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
    Title
    High frequency band
    Description
    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
    Title
    Entropy
    Description
    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
    Title
    Short term detrended fluctuation analysis
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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

    Learn more about this trial

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

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