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Women's Health

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

Sponsored by University of Sao Paulo General Hospital

About this trial

Last updated 13 years ago

Study ID

TRH01/989-7

Status

Completed

Type

Interventional

Phase

N/A

Placebo

Yes

Accepting

18-75 Years
45 to 60 Years
Female
Female

Trial Timing

Ended 16 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

Inclusion Criteria

- Hysterectomy women, with or without ovaries, confirmed by transvaginal ultrasound.

- Climacteric women, postmenopausal for at least 1 year, with vasomotor symptoms (Kupperman, 1959) and/or laboratory diagnosis of menopause (high luteinizing hormone [LH] and follicle-stimulating hormone [FSH] and estradiol decreased).

No

Exclusion Criteria

- Hypertension or other cardiovascular disease (thromboembolism, heart disease, myocardial infarction, stroke, vascular disorders, coronary insufficiency or venous)

- Osteoporosis.

- Diagnose or suspected breast cancer or ovaries.

- Current illness or a history of severe liver failure, jaundice or severe pruritus pregnancy and liver tumor.

- Endocrine and metabolic diseases as diabetes, thyroid disorders, obesity and dyslipidemia.

- Chronic diseases such as kidney diseases and collagen diseases.

- Women with cervical or vaginal malignancies.

- Hypersensitivity to estradiol valerate.

- Previous use of estrogen-containing implants in the last two years, use of hormone replacement therapy (HRT) orally or transdermally in the last three months or HRT use by injection in the last six months before the study start.

- Limited mobility or other physical problems that contraindicate the physical exercises.

- Women who are engaged in regular physical activity.