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

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.

Conditions

• Women's Health

Interventions

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

Sponsors & Collaborators

• Fundação de Amparo à Pesquisa do Estado de São Paulo

  collaborator OTHER_GOV

• University of Sao Paulo General Hospital

  lead OTHER

Principal Investigators

• Angela M Fonseca, PhD · University of Sao Paulo

• Decio Mion Jr, PhD · University of Sao Paulo

• Claudia LM Forjaz, PhD · University of Sao Paulo

• Sandra B Abrahão, PhD · University of Sao Paulo

• Taís Tinucci, PhD · University of Sao Paulo

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

60 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2002-02-28

Primary Completion

2009-02-28

Completion

2009-02-28