Hemodynamic and Salivary Responses of 12 Weeks of Training With Different Anti-hypertensive

NCT03529838 | Terminated DMC

• 1 other identifier: 71285317.4.0000.5152
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Different classes of antihypertensives may have different responses when associated with exercise. Thus, this study aims to compare the responses of the association of 12 weeks of aerobic exercise and weightlifting with different classes of medications in 45 postmenopausal hypertensive women.

Conditions

Hypertension; Menopause

Keywords

Combined Exercise; Ambulatorial Blood Pressure Monitoring; Blood analysis; Salivary analysis; Heart rate variability

Outcome Measures

Primary Outcomes (1)

• Changes in Ambulatorial Blood Pressure

  All volunteers were submitted to a 24-hour Blood Pressure (BP; systolic and diastolic measurements) 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 12 weeks of exercise training

Secondary Outcomes (5)

• Changes in Ambulatorial Blood Pressure Variability

  Before and within 72 hours after 12 weeks of exercise training

• Changes in Heart Rate Variability

  Before and within 72 hours after 12 weeks of exercise training

• Changes in salivary oxidative stress

  Before and within 72 hours after 12 weeks of exercise training

• Changes of blood pressure reactivity

  Before and within 72 hours after 12 weeks of exercise training

• Changes of Biochemical markers on blood

  Before and within 72 hours after 12 weeks of exercise training

Study Arms (3)

No medication

PLACEBO COMPARATOR

Group of pre-hypertensive women with no medication who practiced 12 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

Angiotensin receptor blockers

ACTIVE COMPARATOR

Group of hypertensive women taking Angiotensin receptor blockers who practiced 12 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

Beta blockers

ACTIVE COMPARATOR

Group of hypertensive women taking Beta blockers who practiced 12 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

Interventions

Combined exercise OTHER

The program consisted of 36 sessions of combined aerobic and resistance exercises training during 12 consecutive weeks. Each session lasted 60 minutes and consisted of 30 minutes of resistance exercise and 30 minutes of aerobic exercise. The resistance training was performed in two sets of 8 to 12 repetitions in five exercises of weight training (Based on 1 repetition maximum test - 1RM). 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 65 and 75% of maximun heart rate measured in maximum incremental test. Every week the resistance load and aerobic intensity was readjusted by determined training zone (8 to 12 maximum repetitions) and heart rate predicted in the incremental respectively.

Angiotensin receptor blockers; Beta blockers; No medication

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged between 50 and 70 years;
• Be in the postmenopausal phase;
• Be able to practice physical exercise on treadmill and bodybuilding,
• Receive a release certificate for exercise practice;
• Do not present physical problems or cardiovascular complications that prevent the performance of physical exercises;
• In the case of hypertensives: present stage 1 hypertension, according to the guidelines of the Brazilian Society of Hypertension (2010);
• In the case of hypertensive patients, undergo drug treatment with β-blockers or Angiotensin receptor blockers.

You may not qualify if:

• Present history of stroke or acute myocardial infarction;
• Smokers;
• Present diagnosis of Diabetes Mellitus or renal pathologies;
• Use of antihypertensive drugs from classes that were not selected for this project;
• Make use of hormonal therapies;
• Being uncompensated hypertensive.

Sponsors & Collaborators

• Federal University of Uberlandia: lead

Study Sites (1)

Guilherme Morais Puga

Uberlândia, Minas Gerais, 38400-678, Brazil

Location

Related Publications (1)

• Mariano IM, Amaral AL, V Carrijo VH, Costa JG, Rodrigues ML, Cunha TM, Puga GM. Different cardiovascular responses to exercise training in hypertensive women receiving beta-blockers or angiotensin receptor blockers: A pilot study. Clin Exp Hypertens. 2022 Jul 4;44(5):442-450. doi: 10.1080/10641963.2022.2065290. Epub 2022 Apr 23.

  PMID: 35465803 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

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: Bachelor

Model Details: 45 women taking different antihypertensives (15 no medications, 15 angiotensin receptor blockers and 15 beta blockers) for at least 6 months will be assessed at baseline and after 12 weeks of combined exercise training.

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: May 18, 2018
• Study Start: March 1, 2017
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2021
• Last Updated: March 22, 2022

Record last verified: 2022-03

Locations

BR (1)