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Aerobic Physical Training and Heart Rate Variability in Hypertersion

Primary Purpose

Autonomic Nervous System Diseases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physical training program
Physical training program
Sponsored by
University of Campinas, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autonomic Nervous System Diseases focused on measuring Exercisy therapy, Hypertension, Physiopathology, Heart rate, Nonlinear dynamics

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • SBP ≤ 180 mmHg and DBP ≤ 110 mmHg)
  • low risk for physical training.

Exclusion Criteria:

  • obesity III
  • musculoskeletal conditions
  • peripheral neuropathy
  • Parkinson's disease.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Physical training program

    Control Group

    Arm Description

    Intervention participants are submitted to supervised aerobic physical training at the predetermined intensity, which is composed of three weekly sessions, lasting one hour, over a period of 12 weeks. All sessions were started with stretches for lower and upper limbs lasting 10 minutes for warm-up, and after trekking on treadmill using the predetermined critical velocity (Vcrit). The exercises were completed with cooling of the muscle groups for one minute still on the treadmill, plus 10 minutes of relaxation exercises on the mat at the end of aerobic exercise.

    Control participants receive routine outpatient care for a 12-week period.

    Outcomes

    Primary Outcome Measures

    Heart rate variability will be measured by nonlinear methods in hypertensive patients to observe changes in baseline values after 12 weeks.
    A heart rate meter RS800CX (Polar Electro Co.Ltda. Kempele, Finland) is used to obtain HR and R-R (iR-R) intervals. The iR-Rs are captured from a tape with a coded transmitter placed in the chest region at the 5th intercostal space and transmitted to the cardiofrequency meter where they are recorded

    Secondary Outcome Measures

    The peak oxygen consumption (mL / kg · min) will be measured by ergospirometry in hypertensive patients to observe changes in baseline values after 12 weeks.
    Cardiopulmonary exercise test used to determine peak oxygen consumption to exercise .
    The double product (mmHg) will be measured by ergospirometry in hypertensive patients to observe changes in baseline values after 12 weeks.
    Cardiopulmonary exercise test used to determine double produc to exercise .
    The oxigen pulse (ml/heart rate) will be measured by ergospirometry in hypertensive patients to observe changes in baseline values after 12 weeks.
    Cardiopulmonary exercise test used to determine oxigen pulse to exercise .

    Full Information

    First Posted
    February 19, 2017
    Last Updated
    February 21, 2017
    Sponsor
    University of Campinas, Brazil
    Collaborators
    Medical Outpatient Vlinic of the Government of the State of São Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03064256
    Brief Title
    Aerobic Physical Training and Heart Rate Variability in Hypertersion
    Official Title
    EFFECT OF AEROBIC PHYSICAL TRAINING WITH DETERMINED INTENSITY FOR THE PROTOCOL OF DOUBLE EXHAUSTIVE EFFORTS IN THE AUTONOMICAL MODULATION OF THE HEART FREQUENCY OF PATIENTS WITH SYSTEMIC ARTERIAL HYPERTENSION
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 14, 2014 (Actual)
    Primary Completion Date
    December 21, 2015 (Actual)
    Study Completion Date
    January 16, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Campinas, Brazil
    Collaborators
    Medical Outpatient Vlinic of the Government of the State of São Paulo

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study compared the changes in the cardiovascular, hemodynamic and metabolic variables of hypertensive patients who received aerobic physical training with intensity determined by the protocol of double non-exhaustive efforts (DENE) with that of patients who received routine outpatient care 12 weeks after Entry into the study. 63 men and women participated in the study and were allocated in the intervention group (n = 42) and control group (n = 21).The following were performed: Cardiopulmonary exercise test (TECP) for evaluation of peak oxygen consumption (VO2peak), oxygen pulse and double product; DENE protocol for the determination of the intensity of the training. It was obtained the recording of the intervals between consecutive heart beats (iRR) to evaluate the autonomic modulation of the heart rate. Body mass index, waist circumference (AC), hip circumference (CQ) and Waist / hip ratio (WHR) were measured.
    Detailed Description
    The study was designed to compare changes in the cardiovascular, hemodynamic and metabolic variables of hypertensive patients who received aerobic physical training with intensity determined by the DENE protocol with that of patients who received routine ambulatory care 12 weeks after entering the study. Sixty-three hypertensive men and women, divided into the intervention group (GI) (n=42) and the control group (n = 21) participated in the study. All procedures were performed by trained researchers and qualified staff and the evaluations and intervention were performed at the specialty medical outpatient clinic. After agreeing to participate in the study, we collected sociodemographic and clinical data, body mass index (BMI), waist circumference (WC) and waist / hip ratio (WHR). The participants were submitted to the cardiopulmonary exercise test (TECP), to evaluate the peak oxygen consumption (VO2peak), oxygen pulse and double product. Between one and seven days after TECP, consecutive heart rate intervals (iRR) were recorded for evaluation of autonomic heart rate modulation using a Polar model RS800CX (Polar Electro Co.Ltda Kempele, Finland). . The DENE protocol for determining the intensity of the training was applied in the GI to determine the training intensity in the treadmill. Intervention participants underwent supervised aerobic physical training at the pre-determined intensity, which consisted of three weekly sessions, lasting one hour, over a period of 12 weeks. Control participants receive routine care from the outpatient clinic for the same period. At the end of the 12 weeks, measures, recording of the iRR intervals, oxygen pulse, double product, BMI, waist circumference (AC), hip circumference (QC) and waist / hip ratio (WHR) were obtained. All subjects were previously informed about the procedures Signed a free and informed consent form. The project was approved by the Commission of Research Committee of the Institution with the number 086.096 / 14.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Autonomic Nervous System Diseases
    Keywords
    Exercisy therapy, Hypertension, Physiopathology, Heart rate, Nonlinear dynamics

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    63 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Physical training program
    Arm Type
    Experimental
    Arm Description
    Intervention participants are submitted to supervised aerobic physical training at the predetermined intensity, which is composed of three weekly sessions, lasting one hour, over a period of 12 weeks. All sessions were started with stretches for lower and upper limbs lasting 10 minutes for warm-up, and after trekking on treadmill using the predetermined critical velocity (Vcrit). The exercises were completed with cooling of the muscle groups for one minute still on the treadmill, plus 10 minutes of relaxation exercises on the mat at the end of aerobic exercise.
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    Control participants receive routine outpatient care for a 12-week period.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Physical training program
    Intervention Description
    Physical training program consisted of three weekly sessions lasting up to one hour over a period of twelve weeks. and will be carried out respecting the traditional training principles: biological individuality, Specificity, overload, adaptation and reversibility
    Intervention Type
    Behavioral
    Intervention Name(s)
    Physical training program
    Intervention Description
    All sessions were started with stretches for lower and upper limbs lasting 10 minutes for warm-up, and after trekking on treadmill using the predetermined critical velocity (Vcrit). The exercises were completed with cooling of the muscle groups for one minute still on the treadmill, plus 10 minutes of relaxation exercises on the mat at the end of aerobic exercise.
    Primary Outcome Measure Information:
    Title
    Heart rate variability will be measured by nonlinear methods in hypertensive patients to observe changes in baseline values after 12 weeks.
    Description
    A heart rate meter RS800CX (Polar Electro Co.Ltda. Kempele, Finland) is used to obtain HR and R-R (iR-R) intervals. The iR-Rs are captured from a tape with a coded transmitter placed in the chest region at the 5th intercostal space and transmitted to the cardiofrequency meter where they are recorded
    Time Frame
    Finalized study (12 weeks)
    Secondary Outcome Measure Information:
    Title
    The peak oxygen consumption (mL / kg · min) will be measured by ergospirometry in hypertensive patients to observe changes in baseline values after 12 weeks.
    Description
    Cardiopulmonary exercise test used to determine peak oxygen consumption to exercise .
    Time Frame
    Finalized study (12 weeks)
    Title
    The double product (mmHg) will be measured by ergospirometry in hypertensive patients to observe changes in baseline values after 12 weeks.
    Description
    Cardiopulmonary exercise test used to determine double produc to exercise .
    Time Frame
    Finalized study (12 weeks)
    Title
    The oxigen pulse (ml/heart rate) will be measured by ergospirometry in hypertensive patients to observe changes in baseline values after 12 weeks.
    Description
    Cardiopulmonary exercise test used to determine oxigen pulse to exercise .
    Time Frame
    Finalized study (12 weeks)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: SBP ≤ 180 mmHg and DBP ≤ 110 mmHg) low risk for physical training. Exclusion Criteria: obesity III musculoskeletal conditions peripheral neuropathy Parkinson's disease.

    12. IPD Sharing Statement

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