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

Exercise Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03531034
• Other study ID #: 40622414.9.0000.5152
• Status: Completed
• Phase: N/A
• Start date: March 1, 2014
• Est. completion date: December 25, 2016

Study information

• Verified date: January 2021
• Source: Federal University of Uberlandia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 25, 2016
• Est. primary completion date: December 25, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure, High
• Exercise
• Hypertension
• Menopause

Intervention

Other:
• Combined Exercise Training
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.

Locations

Country	Name	City	State
Brazil	Guilherme Morais Puga	Uberlandia	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Uberlandia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Before and within 72 hours after 10 weeks of exercise training
Secondary	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.	Before and within 72 hours after 10 weeks of exercise training
Secondary	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.	Before and within 72 hours after 10 weeks of exercise training
Secondary	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.	Before and within 72 hours after 10 weeks of exercise training