University of Poitiers - UFR STAPS - Laboratory MOVE
Poitiers, 86000, France
NCT Number: NCT07422961
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.
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Notify Me40 year–70 year
Female
Interventional
Not applicable
Poitiers, 86000, France
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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
24 sessions of adapted physical activity at moderate intensity (aerobic exercise)
Time frame: At Visit 1 and Visit 3 (30 minutes)
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.
Time frame: At Visit 1 and Visit 3 (30 minutes)
Modified Borg scale during the cardiorespiratory exercise test (scored 0 to 10, higher score indicates lower exercise tolerance).
Time frame: At Visit 1 and Visit 3 (30 minutes)
Near-infrared spectroscopy is used to measure concentrations of oxygenated and desoxygenated hemoglobin (µmol/L) during the cardiorespiratory exercise test.
Time frame: At Visit 2 and Visit 4 (5 minutes)
Percentage of body fat and fat-free mass using the Tanita impedance scale.
Time frame: At Visit 2 and Visit 4 (5 minutes)
Calculated from total body weight and height (kg/m²).
Time frame: At Visit 2 and Visit 4 (15 minutes)
At rest, using the SphygmoCor device, which measures central blood pressure (mmHg).
Time frame: At Visit 2 and Visit 4 (15 minutes)
At rest, using the SphygmoCor device, which calculates carotid-femoral pulse wave velocity (m/s).
Time frame: At Visit 2 and Visit 4 (30 minutes)
At rest, the flow-mediated dilatation technique is used with high-resolution Doppler ultrasound (CX-50 Philipps).
Time frame: After Visit 2 and Visit 4 (during 24 hours)
Systolic and diastolic blood pressure profile using the Mobil-O-Graph (mmHg).
Time frame: At Visit 2 and Visit 4 (10 minutes)
Composed of 29 items rating the impact of self-reported climateric symptoms in four domains (vasomotor, psychosocial, physical, and sexual).
Time frame: At Visit 2 and Visit 4 (10 minutes)
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)
Time frame: Baseline
Age, and menopause age (in years)
Time frame: Baseline
Self-reported
Time frame: Baseline
Current, former, never
Time frame: Baseline
Time frame: Baseline
Time frame: Baseline (5 minutes)
Ricci & Gagnon Questionnaire - Inclusion criteria
Time frame: Baseline
17-beta-estradiol, and follicle-stimulating hormone (ng/L) - Inclusion criteria
Time frame: Baseline
Biomarker of cardiac insufficiency (pg/mL) - Inclusion criteria
Time frame: Baseline
Biomarker of uncontrolled thyroid (MUI/L) - Inclusion criteria
Time frame: Baseline
Hemoglobin (g/dL), hematocrit (%) - Inclusion criteria
Time frame: At Visit 1 (baseline, 15 minutes)
FEV₁/FVC ratio - Inclusion criteria
Time frame: At Visit 1 (baseline, 30 minutes)
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
University of Poitiers
Other
Response to Endurance Training in Postmenopausal Women With Exercise Intolerance.
Acronym: WOMEN-EX-IC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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