Isolated and Associated Effects of Physical Exercise and Estrogen Therapy on Climactercs Women

2014-07-24 14:05:47 | BioPortfolio


This study will investigate the isolated and the associated effect of estrogen therapy and physical exercise in the function, regulation and cardiovascular risk markers of 60 postmenopausal women, (45 - 60 years old). The volunteers will be randomaized into two groups: estrogen therapy (estradiol valerate 1 mg/day oraly) and placebo. The two groups will be randomaized into two subgroups: exercise group (aerobic trainning,cicle-ergometre, 50 minutes, 3 x week) and sedentary group. At 0, 6 and 12 months the volunteers will be submited to: clinical analise, cardiorespiratory analise (ergoepirometric test), quality of life questionare (Short Form-36 [SF-36]), ambulatory blood pressure monitoring during 24 hours and to 2 experimental sessions where the cardiovascular responses to insulin action (euglicemic/hiperinsulinemic clamp) and to physical and mental stress (microneurography) will be accessed. Besides these, the volunteers of the sedentary group will be submited to an extra session at 6 months of study evaluate the physiological answer to insulin infusion after an acute session of exercise.


More than an isolated event, menopause is an universal process that produces many physiologic changes, affecting not only the reproductive tissues but other systems of women's body. Post-menopause period is usually accompanied by an increase in climacteric symptoms, which decrease healthy related quality of life. Moreover, many unhealthy changes occur at this period of women's life, increasing the risk for metabolic syndrome development, which might be due, at least in part, to an increase in insulin resistance and compensatory hyperinsulinemia.

Hormone therapy is indicated as the main treatment to reduce or relief the negative effects of menopause. Although many studies have confirmed the possible positive effects of this approach on postmenopausal symptoms, its effects on insulin resistance and other metabolic syndrome factors remain controversial.

On the other hand, it's well known that acute and chronic exercises can provide a wide range of benefits for postmenopausal women's health, including decrease of insulin resistance and symptoms relief.

In clinical practice, many postmenopausal women are using hormone therapy and are instructed to exercise. However, the effects of this association are poorly studied.

Thus, the main goal of this randomized placebo-controlled trial was to evaluate, in healthy, middle age, and hysterectomized postmenopausal women, the single and combined effects of physical exercise and oral estrogen use on blood pressure (BP), heart rate (HR), muscle blood flow, and autonomic function measured at baseline conditions and under hyperinsulinemia stimulus. Moreover, it also investigated the effects of these interventions on symptoms relief and quality of life.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research


Women's Health


Estradiol valerate, Aerobic training, Placebo, Control




University of Sao Paulo General Hospital

Results (where available)

View Results


Published on BioPortfolio: 2014-07-24T14:05:47-0400

Clinical Trials [4728 Associated Clinical Trials listed on BioPortfolio]

A Study of Prevention and Treatment of Postmenopausal Osteoporosis in Chinese Women

The purpose of this trial is to study the efficacy and safety of low dose of estradiol valerate in the prevention and treatment of postmenopausal osteoporosis.

Bioequivalence Study: 3 mg Estradiol Valerate (EV) With and Without Levomefolate Calcium

Investigation of the bioequivalence (BE) of Estradiol Valerate (EV) after administration of one film-coated tablet containing 3 mg Estradiol Valerate and 0.451 mg Levomefolate calcium as c...

The Influence of Estradiol Supplementation During the Luteal in Patients Undergoing IVF Treatment

To evaluate whether treatment with Estradiol supplementation during the luteal phase improves IVF outcomes Patients undergoing IVF treatment with controlled ovarian hyperstimulation using...

Luteal Phase Support With Estradiol In Poor Responders Undergoing In Vitro Fertilization

The role of progesterone (P) supplementation in the luteal phase of in vitro fertilization (IVF) cycles is well established world-wide , but the influence of the luteal phase estradiol lev...

Effect Sildenafil and Estradiiol Valerate on Endometrial Thickness in Infertile Women

The endometrium is a dynamic tissue that responds to changing hormonal signals throughout the cycle. The changes in the endometrial composition are expressed in alteration in gene expressi...

PubMed Articles [28199 Associated PubMed Articles listed on BioPortfolio]

Exercise training in thermo-mineral spring water has beneficial effects on hemodynamic and health-related factors in young-older hypertensive women: A randomized control trial.

The aim of the study was to evaluate the effects of an 8-week aerobic training in mineral geothermal water on hemodynamic variables, VO, and body composition in sedentary hypertensive women. Twenty po...

Effect of exercise order of combined aerobic and resistance training on arterial stiffness in older men.

Arterial stiffness increases with advancing age, and is as an emerging biomarker in the assessment of vascular health. Some studies suggest that high-intensity resistance training increases arterial s...

Randomized Controlled Trial Evaluating Aerobic Training and Common Sport-Related Concussion Outcomes in Healthy Participants.

Aerobic exercise interventions are increasingly being prescribed for concussion rehabilitation, but whether aerobic training protocols influence clinical concussion diagnosis and management assessment...

27-hydroxycholesterol, an endogenous SERM, and risk of fracture in postmenopausal women: A nested case-cohort study in the Women's Health Initiative.

27-hydroxycholesterol (27HC) is a purported, novel endogenous SERM. In animal models, 27HC has an anti-estrogen effect in bone, and 17β-estradiol mitigates this effect. 27HC in relation to fracture r...

A phase 2b multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of vaginal rings containing nomegestrol acetate or etonogestrel and 17β-estradiol in the treatment of women with primary dysmenorrhea.

To evaluate the effect of investigational vaginal rings containing nomegestrol acetate (NOMAC) plus 17β-estradiol (E2) or etonogestrel (ENG) plus E2 in women with moderate to severe primary dysmenorr...

Medical and Biotech [MESH] Definitions

WHO regional office for the Americas acting as a coordinating agency for the improvement of health conditions in the hemisphere. The four main functions are: control or eradication of communicable diseases, strengthening of national and local health services, education and training, and research.

Education centers authorized by the Comprehensive Health Manpower Training Act, 1971, for the training of health personnel in areas where health needs are the greatest. May be used for centers other than those established by the United States act.

Generally refers to the 17-beta-isomer of estradiol, an aromatized C18 steroid with hydroxyl group at 3-beta- and 17-beta-position. Estradiol-17-beta is the most potent form of mammalian estrogenic steroids. In humans, it is produced primarily by the cyclic ovaries and the PLACENTA. It is also produced by the adipose tissue of men and postmenopausal women. The 17-alpha-isomer of estradiol binds weakly to estrogen receptors (RECEPTORS, ESTROGEN) and exhibits little estrogenic activity in estrogen-responsive tissues. Various isomers can be synthesized.

Steroidal compounds related to ESTRADIOL, the major mammalian female sex hormone. Estradiol congeners include important estradiol precursors in the biosynthetic pathways, metabolites, derivatives, and synthetic steroids with estrogenic activities.

The concept covering the physical and mental conditions of women.

More From BioPortfolio on "Isolated and Associated Effects of Physical Exercise and Estrogen Therapy on Climactercs Women"

Quick Search


Relevant Topics

Cardiovascular disease (CVD)
Acute Coronary Syndromes (ACS) Blood Cardiovascular Dialysis Hypertension Stent Stroke Vascular Cardiovascular disease (CVD) includes all the diseases of the heart and circulation including coronary heart disease (angina...

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Searches Linking to this Trial