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

About this trial
This is an interventional treatment trial for Hypertension focused on measuring exercise, resistant hypertension, blood pressure
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
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
NCT ID
NCT02987452
First Posted
December 6, 2016
Last Updated
December 13, 2016
Sponsor
Heitor Moreno Junior
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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