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

NCT03531034 | Completed DMC

• 1 other identifier: 40622414.9.0000.5152
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause; Exercise; Blood Pressure, High

Keywords

Blood Pressure Variability; Ambulatorial Blood Pressure Monitoring; Combined Exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Changes in Ambulatorial Blood Pressure Variability

  Before and within 72 hours after 10 weeks of exercise training

• Changes in Heart Rate Variability

  Before and within 72 hours after 10 weeks of exercise training

• Changes in salivary oxidative stress

  Before and within 72 hours after 10 weeks of exercise training

Study Arms (2)

Hypertensive Women

EXPERIMENTAL

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

Other: Combined Exercise Training

Normotensive Women

ACTIVE COMPARATOR

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.

Other: Combined Exercise Training

Interventions

Combined Exercise Training OTHER

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.

Hypertensive Women; Normotensive Women

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of Uberlandia: lead

Study Sites (1)

Guilherme Morais Puga

Uberlândia, Minas Gerais, 38400-678, Brazil

Location

MeSH Terms

Conditions

Motor Activity; Hypertension

Condition Hierarchy (Ancestors)

Behavior; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Guilherme M Puga, Dr

  Federal University of Uberlandia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: May 21, 2018
• Study Start: March 1, 2014
• Primary Completion: December 25, 2015
• Study Completion: December 25, 2016
• Last Updated: January 11, 2021

Record last verified: 2021-01

Locations

BR (1)