Faculty of Sport Science - MOVE Laboratory (UR20296)
Poitiers, 86000, France
NCT Number: NCT06533982
Menopause is a natural stage in female aging, increasing cardiometabolic risk and making cardio-neuro-vascular disease (CNVD) the leading cause of mortality in women over 60. Declining ovarian hormones are linked to changes in body composition, increased blood pressure, and mild cognitive impairment. Menopause also often involves significant symptoms like menopausal vasomotor symptoms (VMS), affecting 60-80% of women for 5-10 years. Women with VMS exhibit a worse cardiovascular profile and greater cognitive decline.
Physical exercise is a promising non-pharmacological option to reduce CNVD risk and limit cognitive impairment in postmenopausal women, who have a 10-year window post-menopause during which physical activity benefits vascular and possibly neurovascular health. Studies link physical activity to lower cognitive decline and improved quality of life. However, optimal exercise modalities for managing CNVD risk in postmenopausal women remain undetermined.
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Notify Me45 year–65 year
Female
Interventional
Not applicable
Poitiers, 86000, France
Menopause is a natural stage in the female aging process, resulting in increased cardiometabolic risk, making cardio-neuro-vascular disease (CNVD) the leading cause of female mortality worldwide after the age of 60. Indeed, falling ovarian hormone concentrations are associated with altered body composition, increased blood pressure, as well as mild cognitive impairment.
For some women, menopause is also accompanied by symptoms that have a significant impact on their quality of life. Among these, menopausal vasomotor symptoms (VMS - hot flushes, night sweats...) are the most frequent, affecting 60% to 80% of women for an average of 5 to 10 years. Several studies have highlighted an altered cardiovascular profile (dyslipidemia, insulin resistance, pre-hypertension/hypertension...) and a more marked decline in cognitive performance in women with VMS.
In order to reduce the risk of CNVD and limit cognitive impairment, physical exercise appears to be a particularly interesting non-pharmacological management option for postmenopausal women. Indeed, the latter seem to present a 10-year post-menopausal time window, during which physical activity has a positive vascular and probably neurovascular effect, although the latter remains to be demonstrated. Numerous studies have also shown that physical activity is associated with a lower rate of cognitive decline, and improved quality of life.
However, to date, there is little evidence to determine which exercise modalities are most effective in managing the risk of CNVD in postmenopausal women.
The aims of this study:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Physical activity session supervised and adapted on ergometer
Physical activity session supervised and adapted with a handgrip
Time frame: After sessions (24 hours)
Post-exercise hypotension, using the Mobil-O-Graph (mmHg).
Time frame: Before and after sessions (15 minutes)
Automated oscillometric tensiometer (mmHg).
Time frame: Before, during, and after sessions (1 hour)
Near-infrared spectroscopy is used to measure concentrations of oxygenated and desoxygenated hemoglobin (µmol/L).
Time frame: Before and after sessions (10 minutes)
2-back task (scored from 0 to 28, higher scores indicate better working memory).
Time frame: Before and after sessions (15 minutes)
Memory scale III (MEM-III), a story recall task taken from the test battery in the Wechsler-Memory Scale-Revised (scored from 0 to 25, higher scores indicate better episodic memory).
Time frame: Before and after sessions (15 minutes)
Stroop task, used to assess inhibitory control (scored as a ratio, negative score indicates worse inhibitory control vs. positive score indicates better inhibitory control).
Time frame: After sessions (1 minute)
Modified Borg scale (scored 0 to 10, higher score indicates lower exercise tolerance).
Time frame: Baseline (30 minutes)
At rest, the flow-mediated dilatation technique is used with high-resolution Doppler ultrasound (CX-50 Philipps).
Time frame: Baseline (1 hour)
At rest, baroreflex sensitivity is measured using the Finapres.
Time frame: Baseline (15 minutes)
At rest, using the SphygmoCor device, which measures central blood pressure (mmHg).
Time frame: Baseline (15 minutes)
At rest, using the SphygmoCor device, which calculates carotid-femoral pulse wave velocity (m/s).
Time frame: Baseline (30 minutes)
Maximal cardiopulmonary effort test (VO2max).
Time frame: Baseline (5 minutes)
Total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), and triglycerides (g/L).
Time frame: Baseline (5 minutes)
Progesterone, 17-beta-estradiol, and follicle-stimulating hormone (ng/L).
Time frame: Baseline (1 minute)
Total body weight, fat mass, fat-free mass and visceral-fat mass in kilograms using the Tanita impedance scale.
Time frame: Baseline (1 minute)
Percentage of body fat and fat-free mass using the Tanita impedance scale.
Time frame: Baseline (1 minute)
Height in meters measured with a height gauge.
Time frame: Baseline (1 minute)
Calculated from total body weight and height (kg/m²).
Time frame: Baseline (15 minutes)
Montreal Cognitive Assessment (MoCA) test (scored from 0 to 30, with higher scores indicating better cognitive function).
Time frame: Baseline (15 minutes)
Composed of 11 items rating the severity of menopausal symptoms from 0 (no symptoms) to 4 (very severe).
Time frame: Baseline (15 minutes)
Composed of 10 items scored from 0 (no impact) to 10 (completely interferes), evaluating the impact of vasomotor symptoms on daily life.
Time frame: Baseline (15 minutes)
It provides two scores ranging from 0 to 21 that quantify anxiety and depression. Higher scores indicate more severe symptoms.
Time frame: Baseline (15 minutes)
Physical activity and sedentary time assessed using the Global Physical Activity Questionnaire. Higher scores indicate better physical activity levels (categorized into high, moderate, and low physical activity levels).
Time frame: Baseline
Use daily or not use.
Time frame: Baseline
Age, age at menarche and menopause (in years).
Time frame: Baseline
Secondary education, high school graduate, bachelor's degree, master's or doctoral degree.
Time frame: Baseline
Self-reported.
University of Poitiers
Other
Effect of Different Exercise Modalities on Cardiovascular and Cognitive Response in Postmenopausal Women With and Without Vasomotor Symptoms
Acronym: WOMEN-EX-MOD
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