NCT01120665

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: Female
• Age: 45 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Women's Health

Interventions

Type	Name	Description
DRUG	Estradiol valerate	estradiol valerate, 1 mg/day, orally.
OTHER	Aerobic training	Aerobic trainin (cycleergometer, 3x/week, moderate intensity, 50 minutes)
DRUG	Placebo	lactose powder, corn starch, microcrystalline cellulose, and magnesium stearate
OTHER	Control	The control group was advised to maintain their normal habits, and not to begin any physical exercise program during the study period

Timeline

• Start date: 2002-02-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2010-05-11
• Last updated: 2012-06-22