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| Name | Class |
|---|---|
| Elsan | OTHER |
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Cardiovascular diseases (CVDs) remain the leading cause of morbidity and mortality worldwide and represent a major public health challenge, with growing evidence highlighting important sex-related differences in their epidemiology, clinical presentation, and pathophysiology. In particular, menopause is associated with an increased cardiovascular risk, likely due to the decline in sex hormones and related changes in cardiac structure and function, vascular properties, and metabolic regulation. Several studies show that physical activity and, more specifically, aerobic training improves exercise tolerance and quality of life in patients. However, no studies have evaluated the effects of hormonal status, despite numerous studies on healthy subjects highlighting the influence of sex hormones on cardiovascular responses to acute and chronic exercise.
Cardiovascular diseases (CVDs) remain the leading cause of morbidity and mortality worldwide and represent a major public health challenge. Importantly, growing evidence highlights significant sex-related differences in the epidemiology, clinical presentation, and pathophysiology of cardiovascular diseases. In particular, postmenopause represents a period of life associated with an increased risk of CVD.
Several physiological mechanisms may underlie these sex-related disparities. Differences in cardiac structure and function, vascular properties, and metabolic regulation contribute to distinct cardiovascular health between men and women. Moreover, the transition to menopause and the associated decline in circulating sex hormones are thought to play a key role in cardiovascular remodeling and functional alterations.
For many years, physical activity has been considered a first-line non-pharmacological strategy in the prevention and treatment of cardiovascular diseases. More specifically, aerobic training has been shown to improves exercise tolerance and quality of life in patients. Indeed, sentinel studies highlight an improvement in aerobic power (VO2 peak) linked to peripheral adaptations (increase in the arteriovenous difference in O2 in the muscles used) and not to central adaptations (no changes in systolic and diastolic functions). However, these studies did not assess the effects of hormonal status , whereas numerous studies on healthy subjects have highlighted the influence of sex hormones on cardiovascular responses to acute and chronic exercise.
The aims of this study:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Training | Experimental | 24 sessions of adapted physical activity at moderate intensity (aerobic exercise) |
|
| Control | No Intervention | Maintaining lifestyle habits |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Training | Other | 24 sessions of adapted physical activity at moderate intensity (aerobic exercise) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiorespiratory fitness | Maximal cardiopulmonary exercise test (VO2 peak) on a cycloergometer using an incremental protocol, supervised by a cardiologist. The test started at 30 watts, increasing by 15 watts per minute until maximum capacity was reached. | At Visit 1 and Visit 3 (30 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise tolerance | Modified Borg scale during the cardiorespiratory exercise test (scored 0 to 10, higher score indicates lower exercise tolerance). | At Visit 1 and Visit 3 (30 minutes) |
| Muscle oxygenation |
| Measure | Description | Time Frame |
|---|---|---|
| Age | Age, and menopause age (in years) | Baseline |
| Number of children | Self-reported | Baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Poitiers - UFR STAPS - Laboratory MOVE | Poitiers | 86000 | France |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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Near-infrared spectroscopy is used to measure concentrations of oxygenated and desoxygenated hemoglobin (µmol/L) during the cardiorespiratory exercise test.
| At Visit 1 and Visit 3 (30 minutes) |
| Body composition | Percentage of body fat and fat-free mass using the Tanita impedance scale. | At Visit 2 and Visit 4 (5 minutes) |
| Body mass index | Calculated from total body weight and height (kg/m²). | At Visit 2 and Visit 4 (5 minutes) |
| Aortic systolic and diastolic blood pressure | At rest, using the SphygmoCor device, which measures central blood pressure (mmHg). | At Visit 2 and Visit 4 (15 minutes) |
| Arterial stiffness (pulse wave velocity) | At rest, using the SphygmoCor device, which calculates carotid-femoral pulse wave velocity (m/s). | At Visit 2 and Visit 4 (15 minutes) |
| Endothelial function (brachial artery dilation capacity) | At rest, the flow-mediated dilatation technique is used with high-resolution Doppler ultrasound (CX-50 Philipps). | At Visit 2 and Visit 4 (30 minutes) |
| Systolic and diastolic blood pressure (ambulatory blood pressure measurement) | Systolic and diastolic blood pressure profile using the Mobil-O-Graph (mmHg). | After Visit 2 and Visit 4 (during 24 hours) |
| The Menopause-specific Quality of Life Questionnaire (MENQOL) | Composed of 29 items rating the impact of self-reported climateric symptoms in four domains (vasomotor, psychosocial, physical, and sexual). | At Visit 2 and Visit 4 (10 minutes) |
| SF-36 questionnaire | 36-item self-report questionnaire measuring health-related quality of life across eight domains (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health) | At Visit 2 and Visit 4 (10 minutes) |
| Tobacco use | Current, former, never | Baseline |
| Comorbidities | Baseline |
| Medical treatment | Baseline |
| Physical activity level | Ricci & Gagnon Questionnaire - Inclusion criteria | Baseline (5 minutes) |
| Blood hormone concentrations | 17-beta-estradiol, and follicle-stimulating hormone (ng/L) - Inclusion criteria | Baseline |
| NTproBNP | Biomarker of cardiac insufficiency (pg/mL) - Inclusion criteria | Baseline |
| TSH | Biomarker of uncontrolled thyroid (MUI/L) - Inclusion criteria | Baseline |
| Complete Blood Count | Hemoglobin (g/dL), hematocrit (%) - Inclusion criteria | Baseline |
| Spirometry | FEV₁/FVC ratio - Inclusion criteria | At Visit 1 (baseline, 15 minutes) |
| Stress echocardiography | A progressive incremental exercise test performed on a supine ergometer, combined with echocardiographic measurements taken before, during, and after exercise in order to detect ischemia, contractile abnormalities, valvular dysfunction. - Inclusion criteria | At Visit 1 (baseline, 30 minutes) |