Isolated and Associated Effects of Physical Exercise and Estrogen Therapy on Climactercs Women
Condition: Women's Health
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Estradiol valerate; Aerobic training; Placebo; Control
Intervention type(s): Drug; Other; Drug; Other
Intervention description(s): estradiol valerate, 1 mg/day, orally.; Aerobic trainin (cycleergometer, 3x/week, moderate intensity, 50 minutes); lactose powder, corn starch, microcrystalline cellulose, and magnesium stearate; The control group was advised to maintain their normal habits, and not to begin any physical exercise program during the study period
Other intervention name(s): hormone therapy; physical training; sedentary
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: women's health; hormone replacement therapy; exercise