Women's HealthTRH01/989-7NCT01120665
Isolated and Associated Effects of Physical Exercise and Estrogen Therapy on Climactercs Women
A study testing Estradiol valerate and Aerobic training in people with Women's Health, run by University of Sao Paulo General Hospital.
Trial 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). Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Women's Health
- What is being tested?
- Estradiol valerate and Aerobic training
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- Feb 2002to Feb 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
About this study
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.
Read the 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
- Being tested
- Estradiol valerate, Aerobic training, Placebo, Control
- Keywords
- women's health, hormone replacement therapy, exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estradiol valerateDrug
Also called hormone therapy
estradiol valerate, 1 mg/day, orally.
Aerobic trainingOther
Also called physical training
Aerobic trainin (cycleergometer, 3x/week, moderate intensity, 50 minutes)
PlaceboDrug
lactose powder, corn starch, microcrystalline cellulose, and magnesium stearate
ControlOther
Also called sedentary
The control group was advised to maintain their normal habits, and not to begin any physical exercise program during the study period
| Study group | Role | What they receive |
|---|---|---|
| PLACEBO-CONTROL | Experimental | PLACEBO + CONTROL TO EXERCISE Receives: Drug: Placebo; Other: Control |
| ESTROGEN THERAPY + CONTROL | Experimental | ESTROGEN THERAPY (estradiol valerate 1 mg/dia orally) + CONTROL TO EXERCISE Receives: Drug: Estradiol valerate; Other: Control |
| PLACEBO+AEROBIC TRAINING | Experimental | PLACEBO + AEROBIC TRAINING (cicle-ergometer, 50 minutes, 3x week) Receives: 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) Receives: Drug: Estradiol valerate; Other: Aerobic training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: six months
Secondary outcomes (2)
hemodynamics mechanisms
Hemodynamics mechanisms will be evaluate by air-occlusion pletismography
Measured: six months
autonomics mechanisms
autonomics mechanisms will be evaluated by microneurography methods and heart rate and blood pressure variability
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2010 (estimated)
- Study startFeb 2002
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women's HealthStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Eduardo Moacyr Krieger, University of Sao Paulo General Hospital
- Investigators
- Angela M Fonseca, PhD, Principal investigator, University of Sao PauloDecio Mion Jr, PhD, Principal investigator, University of Sao PauloClaudia LM Forjaz, PhD, Principal investigator, University of Sao PauloSandra B Abrahão, PhD, Principal investigator, University of Sao PauloTaís Tinucci, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01120665
- Sponsor's protocol ID
- TRH01/989-7
- Acronym
- TRH01/989-7
- Status last verified
- Jun 2012
- First submitted
- 28 Apr 2010
- Last updated
- 22 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isolated and Associated Effects of Physical Exercise and Estrogen Therapy on Climactercs Women
- ClinicalTrials.gov ID
- NCT01120665
- Acronym / sponsor ID
- TRH01/989-7 / TRH01/989-7
- Conditions
- Women's Health
- Keywords
- women's health, hormone replacement therapy, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Feb 2002
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 11 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PLACEBO-CONTROL | Experimental | Drug: Placebo, Other: ControlPLACEBO + CONTROL TO EXERCISE |
| ESTROGEN THERAPY + CONTROL | Experimental | Drug: Estradiol valerate, Other: ControlESTROGEN THERAPY (estradiol valerate 1 mg/dia orally) + CONTROL TO EXERCISE |
| PLACEBO+AEROBIC TRAINING | Experimental | Other: Aerobic training, Drug: PlaceboPLACEBO + AEROBIC TRAINING (cicle-ergometer, 50 minutes, 3x week) |
| ESTROGEN THERAPY + AEROBIC TRAINING | Experimental | Drug: Estradiol valerate, Other: Aerobic trainingESTROGEN THERAPY (estradiol valerate 1 mg/dia orally) + AEROBIC TRAINING (cicle-ergometer, 50 minutes, 3x week) |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Estradiol valerateAlso: hormone therapyestradiol valerate, 1 mg/day, orally. | Drug | ESTROGEN THERAPY + AEROBIC TRAINING, ESTROGEN THERAPY + CONTROL |
| Aerobic trainingAlso: physical trainingAerobic trainin (cycleergometer, 3x/week, moderate intensity, 50 minutes) | Other | ESTROGEN THERAPY + AEROBIC TRAINING, PLACEBO+AEROBIC TRAINING |
| Placebolactose powder, corn starch, microcrystalline cellulose, and magnesium stearate | Drug | PLACEBO+AEROBIC TRAINING, PLACEBO-CONTROL |
| ControlAlso: sedentaryThe control group was advised to maintain their normal habits, and not to begin any physical exercise program during the study period | Other | ESTROGEN THERAPY + CONTROL, PLACEBO-CONTROL |
Primary outcome
Blood pressure
Time frame: six months
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.
2 secondary outcomes
hemodynamics mechanisms
Time frame: six months
autonomics mechanisms
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela M Fonseca, PhD principal investigator
University of Sao Paulo
Decio Mion Jr, PhD principal investigator
University of Sao Paulo
Claudia LM Forjaz, PhD principal investigator
University of Sao Paulo
Questions about this trial
What is this clinical trial studying?
A study testing Estradiol valerate and Aerobic training in people with Women's Health, run by University of Sao Paulo General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2012.