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Isolated and Associated Effects of Physical Exercise and Estrogen Therapy on Climactercs Women (TRH01/989-7)

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Eduardo Moacyr Krieger, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01120665
First received: April 28, 2010
Last updated: June 21, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Women's Health
 Drug: Estradiol valerate
Other: Aerobic training
Drug: Placebo
Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Health Services Research
Official Title: Isolated and Associated Effects of Physical Exercise and Estrogen Therapy on Climactercs Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Blood pressure [ Time Frame: six months ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • hemodynamics mechanisms [ Time Frame: six months ] [ Designated as safety issue: Yes ]
    Hemodynamics mechanisms will be evaluate by air-occlusion pletismography

  • autonomics mechanisms [ Time Frame: six months ] [ Designated as safety issue: Yes ]
    autonomics mechanisms will be evaluated by microneurography methods and heart rate and blood pressure variability


Enrollment: 62
Study Start Date: February 2002
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PLACEBO-CONTROL
PLACEBO + CONTROL TO EXERCISE
 Drug: Placebo
lactose powder, corn starch, microcrystalline cellulose, and magnesium stearate
Other Name: placebo
Other: Control
The control group was advised to maintain their normal habits, and not to begin any physical exercise program during the study period
Other Name: sedentary
Experimental: ESTROGEN THERAPY + CONTROL
ESTROGEN THERAPY (estradiol valerate 1 mg/dia orally) + CONTROL TO EXERCISE
 Drug: Estradiol valerate
estradiol valerate, 1 mg/day, orally.
Other Name: hormone therapy
Other: Control
The control group was advised to maintain their normal habits, and not to begin any physical exercise program during the study period
Other Name: sedentary
Experimental: PLACEBO+AEROBIC TRAINING
PLACEBO + AEROBIC TRAINING (cicle-ergometer, 50 minutes, 3x week)
 Other: Aerobic training
Aerobic trainin (cycleergometer, 3x/week, moderate intensity, 50 minutes)
Other Name: physical training
Drug: Placebo
lactose powder, corn starch, microcrystalline cellulose, and magnesium stearate
Other Name: placebo
Experimental: ESTROGEN THERAPY + AEROBIC TRAINING
ESTROGEN THERAPY (estradiol valerate 1 mg/dia orally) + AEROBIC TRAINING (cicle-ergometer, 50 minutes, 3x week)
 Drug: Estradiol valerate
estradiol valerate, 1 mg/day, orally.
Other Name: hormone therapy
Other: Aerobic training
Aerobic trainin (cycleergometer, 3x/week, moderate intensity, 50 minutes)
Other Name: physical training

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.

  Eligibility

Ages Eligible for Study:   45 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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).

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01120665

Sponsors and Collaborators
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Angela M Fonseca, PhD University of São 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
  More Information

No publications provided

Responsible Party: Eduardo Moacyr Krieger, Associate Professor, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01120665     History of Changes
Other Study ID Numbers: TRH01/989-7
Study First Received: April 28, 2010
Last Updated: June 21, 2012
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by University of Sao Paulo General Hospital:
women's health
hormone replacement therapy
exercise

Additional relevant MeSH terms:
Contraceptive Agents, Female
Estradiol
Polyestradiol phosphate
Estrogens
Hormones
Estradiol valerate
Estradiol 3-benzoate
 Estradiol 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013