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

NCT01120665 | Completed DMC

• 1 other identifier: TRH01/989-7
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

women's health; hormone replacement therapy; exercise

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• hemodynamics mechanisms

  six months

• autonomics mechanisms

  six months

Study Arms (4)

PLACEBO-CONTROL

EXPERIMENTAL

PLACEBO + CONTROL TO EXERCISE

Drug: Placebo; Other: Control

ESTROGEN THERAPY + CONTROL

EXPERIMENTAL

ESTROGEN THERAPY (estradiol valerate 1 mg/dia orally) + CONTROL TO EXERCISE

Drug: Estradiol valerate; Other: Control

PLACEBO+AEROBIC TRAINING

EXPERIMENTAL

PLACEBO + AEROBIC TRAINING (cicle-ergometer, 50 minutes, 3x week)

Other: Aerobic training; Drug: Placebo

ESTROGEN THERAPY + AEROBIC TRAINING

EXPERIMENTAL

ESTROGEN THERAPY (estradiol valerate 1 mg/dia orally) + AEROBIC TRAINING (cicle-ergometer, 50 minutes, 3x week)

Drug: Estradiol valerate; Other: Aerobic training

Interventions

Estradiol valerate DRUG

estradiol valerate, 1 mg/day, orally.

Also known as: hormone therapy

ESTROGEN THERAPY + AEROBIC TRAINING; ESTROGEN THERAPY + CONTROL

Aerobic training OTHER

Aerobic trainin (cycleergometer, 3x/week, moderate intensity, 50 minutes)

Also known as: physical training

ESTROGEN THERAPY + AEROBIC TRAINING; PLACEBO+AEROBIC TRAINING

Placebo DRUG

lactose powder, corn starch, microcrystalline cellulose, and magnesium stearate

PLACEBO+AEROBIC TRAINING; PLACEBO-CONTROL

Control OTHER

The control group was advised to maintain their normal habits, and not to begin any physical exercise program during the study period

Also known as: sedentary

ESTROGEN THERAPY + CONTROL; PLACEBO-CONTROL

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

MeSH Terms

Conditions

Motor Activity

Interventions

Estradiol; Physical Conditioning, Human

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• 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

• Taís Tinucci, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 28, 2010
• First Posted: May 11, 2010
• Study Start: February 1, 2002
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: June 22, 2012

Record last verified: 2012-06