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Ambulatory and Blood Pressure Variability Responses to Exercise in Normotensive and Hypertensive Women

Primary Purpose

Menopause, Exercise, Blood Pressure, High

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Combined Exercise Training
Sponsored by
Federal University of Uberlandia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Menopause focused on measuring Blood Pressure Variability, Ambulatorial Blood Pressure Monitoring, Combined Exercise

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • amenorrhea for at least 12 months; body mass index ≤30 kg/m2; ability to engage in treadmill and resistance exercises; hypertension nom-medicated with beta-blockers

Exclusion Criteria:

  • history of diabetes, cancer or cardiovascular disease (except for hypertension in Hypertensive group); doing hormone therapy or soy derived supplementation; smokers

Sites / Locations

  • Guilherme Morais Puga

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hypertensive Women

Normotensive Women

Arm Description

Group of hypertensive and controlled women who practiced 10 weeks of training with Combined Exercise Training, non-obese, nonsmokers and with no characteristics that prevented them from performing the activities. In addition this group could not modify the dose or type of the medicine and should be using the same medicine and dose for at least 6 months

Group of normotensive women who practiced 10 weeks of training with Combined Exercise Training, non-obese, nonsmokers and with no characteristics that prevented them from performing the activities.

Outcomes

Primary Outcome Measures

Changes in Ambulatorial Blood Pressure
All volunteers were submitted to a 24-hour Blood Pressure (BP) assessment by Ambulatorial Blood Pressure Monitoring (ABPM) before and after 10 weeks of combined exercise training, with a minimum of 48 hours after the last training session. A device was used associated with a diary of examination to self-report of activities of daily living (sleep, work, food) or any event that could interfere abnormally with BP or device measurements. The device was always placed 7am and the measurements were made every 15 minutes from 7h to 23h and every 30 minutes from 23h to 7h. The monitoring was considered valid when it happened for a period of 24 hours. The following results were evaluated: systolic blood pressure; diastolic blood pressure, mean blood pressure and heart rate in awake, sleep and 24-hour periods. Before the use ABPM during daily activities, resting blood pressure were measured using the same equipment after 15 min of rest in siting position.

Secondary Outcome Measures

Changes in Ambulatorial Blood Pressure Variability
Based on Ambulatorial Blood Pressure data, were calculated Blood Pressure Variability by: 24-hour standard deviation weighted by the time interval between consecutive readings; the mean diurnal and nocturnal deviations weighted for the duration of the daytime and nighttime interval; the average real variability weighted for the time interval between consecutive readings; the ambulatory arterial stiffness index calculated by the slope of the trend curve of the dispersion of pressure data; the morning surge that represents the dynamic daytime variation in morning pressure that tends to increase, being assessed from the point of least pressure during sleep in relation to the first two hours after waking; and nocturnal dipping, that represents the average percentage drop of sleep pressure in relation to wakefulness, and individuals with falls of 10% or more are considered dippers and below that are considered nom-dippers.
Changes in Heart Rate Variability
Heart Rate (HR) was recorded using a heart rate monitor in a beat-by-beat basis. HR was registered in a seat position for 20 min of rest. Prior to the HR Variability (HRV) analysis, the RR intervals (RRi) were visually inspected and filtered using a moving average filter. The HRV was analyzed in both time-, frequency- and nonlinear-domain. Being that for frequency-domain analysis, firstly the RRi series were interpolated at 4 Hz and then the signal linear trend component removal was performed using the smooth priors approach.
Changes in salivary oxidative stress
The salivary was collected after 12-hours fasting and the total antioxidant capacity was evaluated using the Ferric-Ability of Plasma (FRAP) methodology and calculated from the standard trolox curve. The activity of the enzyme superoxide dismutase (SOD) was determined based on the auto oxidation capacity of pyrogallol and catalase activity (CAT) by monitoring the consumption of hydrogen peroxide at 240 nm. Lipid peroxidation levels were determined by the TBARS method (thiobarbituric acid reactive substances), using as standard a curve of 1,1,3,3-tetraethoxypropane (TMP). The total protein concentration was obtained by the Bradford method (BRADFORD, 1976), using bovine serum albumin (BSA) as standard. The amounts of nitric oxide (NO) were estimated by the determination of total nitrite by the Griess colorimetric method.

Full Information

First Posted
April 17, 2018
Last Updated
January 7, 2021
Sponsor
Federal University of Uberlandia
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1. Study Identification

Unique Protocol Identification Number
NCT03531034
Brief Title
Ambulatory and Blood Pressure Variability Responses to Exercise in Normotensive and Hypertensive Women
Official Title
Ambulatory and Blood Pressure Variability Responses to Combined Exercise in Normotensive and Hypertensive Menopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2014 (Actual)
Primary Completion Date
December 25, 2015 (Actual)
Study Completion Date
December 25, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Uberlandia

4. Oversight

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

5. Study Description

Brief Summary
This study evaluated the differences between normotensive and hypertensive menopausal women in ambulatory and blood pressure variability responses to combined aerobic and resistance exercise.
Detailed Description
The differences in hypotensive and cardioprotective responses of exercise among menopausal hypertensive and normotensive women are still not very clear, mainly the responses of blood pressure variability. In this way, were evaluated 6 indices related to the variability of 24 hour ambulatory pressure measurements in these women before and after 12 weeks of combined exercise training.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menopause, Exercise, Blood Pressure, High
Keywords
Blood Pressure Variability, Ambulatorial Blood Pressure Monitoring, Combined Exercise

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypertensive Women
Arm Type
Experimental
Arm Description
Group of hypertensive and controlled women who practiced 10 weeks of training with Combined Exercise Training, non-obese, nonsmokers and with no characteristics that prevented them from performing the activities. In addition this group could not modify the dose or type of the medicine and should be using the same medicine and dose for at least 6 months
Arm Title
Normotensive Women
Arm Type
Active Comparator
Arm Description
Group of normotensive women who practiced 10 weeks of training with Combined Exercise Training, non-obese, nonsmokers and with no characteristics that prevented them from performing the activities.
Intervention Type
Other
Intervention Name(s)
Combined Exercise Training
Intervention Description
The program consisted of 30 sessions of combined aerobic and resistance exercises training during 10 consecutive weeks. Each session lasted 45 minutes and consisted of 5 minutes warm-up, 20 minutes of resistance exercise and 20 minutes of aerobic exercise. The resistance training was performed in two sets of 15 repetitions in seven exercises of weight training (Based on 1 repetition maximum test - 1RM) for large muscle groups. The aerobic exercise was performed on a treadmill, at a speed of 5.5 km/h and intensity (imposed by treadmill inclination and heart rate) between ventilatory threshold 1 and 2 intensities. After 5 weeks of training, 1RM test was performed again to readjust the resistance load and aerobic intensity was readjusted by heart rate predicted in the incremental test.
Primary Outcome Measure Information:
Title
Changes in Ambulatorial Blood Pressure
Description
All volunteers were submitted to a 24-hour Blood Pressure (BP) assessment by Ambulatorial Blood Pressure Monitoring (ABPM) before and after 10 weeks of combined exercise training, with a minimum of 48 hours after the last training session. A device was used associated with a diary of examination to self-report of activities of daily living (sleep, work, food) or any event that could interfere abnormally with BP or device measurements. The device was always placed 7am and the measurements were made every 15 minutes from 7h to 23h and every 30 minutes from 23h to 7h. The monitoring was considered valid when it happened for a period of 24 hours. The following results were evaluated: systolic blood pressure; diastolic blood pressure, mean blood pressure and heart rate in awake, sleep and 24-hour periods. Before the use ABPM during daily activities, resting blood pressure were measured using the same equipment after 15 min of rest in siting position.
Time Frame
Before and within 72 hours after 10 weeks of exercise training
Secondary Outcome Measure Information:
Title
Changes in Ambulatorial Blood Pressure Variability
Description
Based on Ambulatorial Blood Pressure data, were calculated Blood Pressure Variability by: 24-hour standard deviation weighted by the time interval between consecutive readings; the mean diurnal and nocturnal deviations weighted for the duration of the daytime and nighttime interval; the average real variability weighted for the time interval between consecutive readings; the ambulatory arterial stiffness index calculated by the slope of the trend curve of the dispersion of pressure data; the morning surge that represents the dynamic daytime variation in morning pressure that tends to increase, being assessed from the point of least pressure during sleep in relation to the first two hours after waking; and nocturnal dipping, that represents the average percentage drop of sleep pressure in relation to wakefulness, and individuals with falls of 10% or more are considered dippers and below that are considered nom-dippers.
Time Frame
Before and within 72 hours after 10 weeks of exercise training
Title
Changes in Heart Rate Variability
Description
Heart Rate (HR) was recorded using a heart rate monitor in a beat-by-beat basis. HR was registered in a seat position for 20 min of rest. Prior to the HR Variability (HRV) analysis, the RR intervals (RRi) were visually inspected and filtered using a moving average filter. The HRV was analyzed in both time-, frequency- and nonlinear-domain. Being that for frequency-domain analysis, firstly the RRi series were interpolated at 4 Hz and then the signal linear trend component removal was performed using the smooth priors approach.
Time Frame
Before and within 72 hours after 10 weeks of exercise training
Title
Changes in salivary oxidative stress
Description
The salivary was collected after 12-hours fasting and the total antioxidant capacity was evaluated using the Ferric-Ability of Plasma (FRAP) methodology and calculated from the standard trolox curve. The activity of the enzyme superoxide dismutase (SOD) was determined based on the auto oxidation capacity of pyrogallol and catalase activity (CAT) by monitoring the consumption of hydrogen peroxide at 240 nm. Lipid peroxidation levels were determined by the TBARS method (thiobarbituric acid reactive substances), using as standard a curve of 1,1,3,3-tetraethoxypropane (TMP). The total protein concentration was obtained by the Bradford method (BRADFORD, 1976), using bovine serum albumin (BSA) as standard. The amounts of nitric oxide (NO) were estimated by the determination of total nitrite by the Griess colorimetric method.
Time Frame
Before and within 72 hours after 10 weeks of exercise training

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: amenorrhea for at least 12 months; body mass index ≤30 kg/m2; ability to engage in treadmill and resistance exercises; hypertension nom-medicated with beta-blockers Exclusion Criteria: history of diabetes, cancer or cardiovascular disease (except for hypertension in Hypertensive group); doing hormone therapy or soy derived supplementation; smokers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guilherme M Puga, Dr
Organizational Affiliation
Federal University of Uberlandia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guilherme Morais Puga
City
Uberlandia
State/Province
Minas Gerais
ZIP/Postal Code
38400-678
Country
Brazil

12. IPD Sharing Statement

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