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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PLACEBO-CONTROL | Experimental | PLACEBO + CONTROL TO EXERCISE |
|
| ESTROGEN THERAPY + CONTROL | Experimental | ESTROGEN THERAPY (estradiol valerate 1 mg/dia orally) + CONTROL TO EXERCISE |
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| PLACEBO+AEROBIC TRAINING | Experimental | PLACEBO + AEROBIC TRAINING (cicle-ergometer, 50 minutes, 3x week) |
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| ESTROGEN THERAPY + AEROBIC TRAINING | Experimental | ESTROGEN THERAPY (estradiol valerate 1 mg/dia orally) + AEROBIC TRAINING (cicle-ergometer, 50 minutes, 3x week) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Estradiol valerate | Drug | estradiol valerate, 1 mg/day, orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Blood pressure will be measured as often as needed, respecting the interval 1-2 minutes among measurements, until you obtain three consecutive measurements with a difference of less than 5 mmHg by auscultation and oscilometric methods. The verification of calibration of the monitor is often assessed by comparison with the mercury. | six months |
| Measure | Description | Time Frame |
|---|---|---|
| hemodynamics mechanisms | Hemodynamics mechanisms will be evaluate by air-occlusion pletismography | six months |
| autonomics mechanisms | autonomics mechanisms will be evaluated by microneurography methods and heart rate and blood pressure variability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angela M Fonseca, PhD | University of Sao Paulo | Principal Investigator |
| Decio Mion Jr, PhD | University of Sao Paulo | Principal Investigator |
| Claudia LM Forjaz, PhD | University of Sao Paulo | Principal Investigator |
| Sandra B Abrahão, PhD | University of Sao Paulo | Principal Investigator |
| TaÃs Tinucci, PhD | University of Sao Paulo | Principal Investigator |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D004958 | Estradiol |
| D064797 | Physical Conditioning, Human |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Aerobic training | Other | Aerobic trainin (cycleergometer, 3x/week, moderate intensity, 50 minutes) |
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| Placebo | Drug | lactose powder, corn starch, microcrystalline cellulose, and magnesium stearate |
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| Control | Other | The control group was advised to maintain their normal habits, and not to begin any physical exercise program during the study period |
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| six months |
| D011083 |
| Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |