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Acute Effects of Different Exercises on Blood Pressure in Hypertensive Subjects

Primary Purpose

Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
aerobic exercise
resistance exercise
combined exercise
Sponsored by
Heitor Moreno Junior
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring exercise, resistant hypertension, blood pressure

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • the diagnosis recommended by the AHA Statement on Resistant Hypertension (2008)
  • a 6-month period clinic follow-up
  • give written informed consent form

Exclusion Criteria:

  • secondary Hypertension
  • pseudoresistance hypertension (poor medication adherence and white coat hypertension)
  • patients with symptomatic ischemic heart disease, impaired renal function, liver disease and history of stroke, myocardial infarction and peripheral vascular diseases, heart failure
  • pregnant women
  • smoking
  • regular physical activity
  • mental or physical limitation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    aerobic exercise

    resistance exercise

    combined exercise

    Arm Description

    Aerobic exercise (EA): activity on a treadmill lasting 45 minutes with intensity of 50-60% of maximum heart rate (HR) obtained from ergometer test

    resistance exercise (RE): 4 series of 12 repetitions of resistance exercises at moderate intensity (until moderate fatigue), for 45 minutes

    combined exercise (CE): EA (25 minutes) + ER (20 minutes), with an interval of 2 minutes between sessions totalizing 45 minutes

    Outcomes

    Primary Outcome Measures

    systolic blood pressure in mmHg
    systolic blood pressure will be assessed for 15 minutes in baseline, 60 minutes and 24 hours post each interventions.

    Secondary Outcome Measures

    arterial stiffness
    by pulse wave velocity, Sphygmocor CPV system
    ambulatory blood pressure monitoring
    ambulatory blood pressure will be assessed in baseline and post each intervention
    interleukin 6
    interleukin 6 will be assessed by ELISA
    interleukin 10
    interleukin 10 will be assessed by ELISA
    tumor necrosis factor alpha
    tumor necrosis factor alpha will be assessed by ELISA

    Full Information

    First Posted
    December 6, 2016
    Last Updated
    December 13, 2016
    Sponsor
    Heitor Moreno Junior
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02987452
    Brief Title
    Acute Effects of Different Exercises on Blood Pressure in Hypertensive Subjects
    Official Title
    Hemodynamic, Autonomic and Inflammatory Answers to Different Types of Exercises in Resistant Hypertensive Patients: an Metabolomic Approach
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2017 (undefined)
    Primary Completion Date
    December 2017 (Anticipated)
    Study Completion Date
    March 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Heitor Moreno Junior

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Lifestyle changes might reduce cardiovascular risk due to the decrease in blood pressure (BP). However, whether combining aerobic and resistance exercises affect BP and hemodynamic parameters, as well as arterial stiffness and inflammation markers in resistant hypertensive (RHTN) patients, have not been investigated yet.
    Detailed Description
    Objective: The investigators aim to evaluate the acute effects of aerobic, resistance and combined (aerobic+ resistance) exercise on the BP, hemodynamic and inflammatory parameters, as well as arterial stiffness in RHTN patients compared to mild to moderate hypertensive (HTN) and normotensive (NT) subjects. Design and Methods: This interventional, randomized, single-blind, crossover study will be conducted in 30 patients (RHTN=10, HTN=10, and NT=10) regularly followed in the Outpatient Resistant Hypertension Clinic at UNICAMP- Brazil. All the subjects will be submitted to a previous adaptation of physical activity, especially to determine the load to be implemented in each patient. Then, the modalities of physical exercises (aerobic, resistance and combined) will be randomly performed in three isolated sessions, which will consist of: a) Aerobic exercise (EA): activity on a treadmill lasting 45 minutes with intensity of 50-60% of maximum heart rate (HR) obtained from ergometer test; b) resistance exercise (RE): 4 series of 12 repetitions of resistance exercises at moderate intensity (until moderate fatigue), for 45 minutes; c) combined exercise (CE): EA (25 minutes) + ER (20 minutes), with an interval of 2 minutes between sessions totalizing 45 minutes. Body composition (plethysmography) and cardiorespiratory functional capacity (ergometry) will be determined before the physical training. In addition, the investigators will assess BP recording (by Finometer, office and ambulatory BP), arterial stiffness (by pulse wave velocity, Sphygmocor CPV system), plasma biomarkers (TNF-α, interleukins -1, -6, -10, and -17 by ELISA) in pre and post periods of each physical exercise. Results: Since the physical exercise in its different modalities provides chronic effects on BP in HTN patients, the investigators hypothesized that the isolated (aerobic and resistance) and combined exercise can acutely promote changes in BP levels in RHTN patients when compared to the participants counterparts. Secondarily, some biological mechanisms related to BP control (vascular function and cytokines production) may also be involved in these possible alterations. Conclusion: The investigators expect to define whether a physical exercise program applied to RHTN patients has medical relevance in a realistic clinical setting. These findings may guide the prescription of physical activity as an additional therapeutic approach, in order to decrease the cardiovascular risk associated to these subjects.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension
    Keywords
    exercise, resistant hypertension, blood pressure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    aerobic exercise
    Arm Type
    Experimental
    Arm Description
    Aerobic exercise (EA): activity on a treadmill lasting 45 minutes with intensity of 50-60% of maximum heart rate (HR) obtained from ergometer test
    Arm Title
    resistance exercise
    Arm Type
    Active Comparator
    Arm Description
    resistance exercise (RE): 4 series of 12 repetitions of resistance exercises at moderate intensity (until moderate fatigue), for 45 minutes
    Arm Title
    combined exercise
    Arm Type
    Active Comparator
    Arm Description
    combined exercise (CE): EA (25 minutes) + ER (20 minutes), with an interval of 2 minutes between sessions totalizing 45 minutes
    Intervention Type
    Other
    Intervention Name(s)
    aerobic exercise
    Intervention Description
    Aerobic exercise (EA): activity on a treadmill lasting 45 minutes with intensity of 50-60% of maximum heart rate (HR) obtained from ergometer test
    Intervention Type
    Other
    Intervention Name(s)
    resistance exercise
    Intervention Description
    resistance exercise (RE): 4 series of 12 repetitions of resistance exercises at moderate intensity (until moderate fatigue), for 45 minutes
    Intervention Type
    Other
    Intervention Name(s)
    combined exercise
    Intervention Description
    combined exercise (CE): EA (25 minutes) + ER (20 minutes), with an interval of 2 minutes between sessions totalizing 45 minutes
    Primary Outcome Measure Information:
    Title
    systolic blood pressure in mmHg
    Description
    systolic blood pressure will be assessed for 15 minutes in baseline, 60 minutes and 24 hours post each interventions.
    Time Frame
    15 minutes
    Secondary Outcome Measure Information:
    Title
    arterial stiffness
    Description
    by pulse wave velocity, Sphygmocor CPV system
    Time Frame
    baseline and 60 minutes post each intervention
    Title
    ambulatory blood pressure monitoring
    Description
    ambulatory blood pressure will be assessed in baseline and post each intervention
    Time Frame
    baseline and post each intervention
    Title
    interleukin 6
    Description
    interleukin 6 will be assessed by ELISA
    Time Frame
    baseline, 60 minutes and 24 hours post each intervention
    Title
    interleukin 10
    Description
    interleukin 10 will be assessed by ELISA
    Time Frame
    baseline, 60 minutes and 24 hours post each intervention
    Title
    tumor necrosis factor alpha
    Description
    tumor necrosis factor alpha will be assessed by ELISA
    Time Frame
    baseline, 60 minutes and 24 hours post each intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: the diagnosis recommended by the AHA Statement on Resistant Hypertension (2008) a 6-month period clinic follow-up give written informed consent form Exclusion Criteria: secondary Hypertension pseudoresistance hypertension (poor medication adherence and white coat hypertension) patients with symptomatic ischemic heart disease, impaired renal function, liver disease and history of stroke, myocardial infarction and peripheral vascular diseases, heart failure pregnant women smoking regular physical activity mental or physical limitation
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nayara F. Pires, PhD student
    Phone
    +551935219538
    Email
    nayarafraccari@yahoo.com.br
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nayara F. Pires, PhD student
    Organizational Affiliation
    University of Campinas
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    35496038
    Citation
    Fraccari-Pires N, Coelho-Junior HJ, Gambassi BB, Cabral de Faria AP, Ritter AMV, Gasparetti CS, Pioli MR, Ruberti OM, Ferreira-Melo SE, Moreno H, Rodrigues B. Cardiovascular Autonomic Responses to Aerobic, Resistance and Combined Exercises in Resistance Hypertensive Patients. Biomed Res Int. 2022 Apr 20;2022:8202610. doi: 10.1155/2022/8202610. eCollection 2022.
    Results Reference
    derived

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    Acute Effects of Different Exercises on Blood Pressure in Hypertensive Subjects

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