Hypertension
Conditions
Interventions
This is an open-label, non-randomized, EIGHT-arm clinical trial. 240 women will be distributed into two large groups: a normotensive group (N=120) and a hypertensive group (N=120). Each large group wi
women between 25 and 45 years old, but who had POI between 25 and 39 years old and have been on HRT for at least two years
women between 55 and 65 years old who had physiological menopause
and women between 55 and 65 years old who had POI between 25 and 39 years old, but undergoing HRT until 51 years old. All groups will undergo the following experimental procedures at two different tim
complete blood count
lipid profile
hormone levels (estrogen, progesterone, FSH, LH and anti-mullerian hormone)
echocardiography
cardiopulmonary exercise test
autonomic assessment by means of analysis of BRS and HRV and BPV
serum levels of catecholamines, inflammatory markers and oxidative stress.
Sponsors
Faculdade de Medicina de Ribeirão Preto Universidade de São Paulo - FMRP/USP
Faculdade de Medicina de Ribeirão Preto Universidade de São Paulo - FMRP/USP
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: The study included normotensive and hypertensive women in two different age groups: 25 to 45 years old, and 55 to 65 years old. The younger group included women with preserved ovarian function, as well as women with premature ovarian failure who had undergone hormone replacement therapy for at least two years. The older group included women who had undergone physiological menopause, as well as women with premature ovarian failure who had undergone hormone replacement therapy until the age of physiological menopause (around 51 years).
Exclusion criteria
Exclusion criteria: Volunteers presenting any of the following conditions will not be included in the study: uncontrolled hypertension, cognitive impairment preventing understanding of the tests and aerobic physical training, musculoskeletal changes preventing physical training, endocrine, metabolic and cardiovascular diseases, such as coronary artery disease and arrhythmias Smokers, individuals using drugs that interfere with cardiac function and cardiovascular autonomic control (e.g. beta-adrenergic blockers), and those using hormone replacement therapy will also be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Women affected by premature ovarian failure, even with hormone replacement therapy, may experience impaired cardiovascular autonomic modulation, which is exacerbated by the concomitant presence of hypertension. Premature ovarian failure (POF) is a condition in which menstruation ceases before the age of physiological menopause. Women who have experienced POF and have undergone hormone replacement therapy (HRT) until the age of physiological menopause may experience impaired cardiovascular autonomic modulation. This condition is exacerbated by the concomitant presence of hypertension. The identification of these impairments is facilitated by spectral analysis of heart rate, which is then compared to conditions before and after the aerobic physical training program.;It is expected to find metabolic alterations, evaluated through blood samples, such as: increase in fasting glucose and insulin; increase in total cholesterol and fractions; increase in triglycerides; increase in C-reactive creatine; increased levels of tumor necrosis and interleukins (IL-6 and IL-10). All these variables are influenced by the aerobic physical training program. | — |
Secondary
| Measure | Time frame |
|---|---|
| The aerobic physical training program may be able to promote in all women affected by hypertension and/or premature ovarian insufficiency the improvement of cardiorespiratory and metabolic function, such as the anaerobic threshold and volume of oxygen consumed at peak exercise (VO2peak) , evaluated by means of the ergospirometric test.;The aerobic physical training program may also be able to promote different cardiac hemodynamic and autonomic effects, decrease inflammatory markers, in addition to improving skeletal muscle strength and functionality, which may provide health benefits. | — |
Countries
Brazil, Colombia
Contacts
Public ContactHugo;Ana Souza;Veiga
Faculdade de Medicina de Ribeirão Preto - FMRP/USP;Faculdade de Medicina de Ribeirão Preto - FMRP/USP
Outcome results
None listed