Blood Pressure, Cognitive Decline, Menopause
Conditions
Keywords
Physical exercise, High intensity interval exercise, Handgrip
Brief summary
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.
Detailed description
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: * To examine the effect of exercise on markers of cardio-neuro-vascular health and cognition in postmenopausal women. * Second, to compare the differences in the cardio-neuro-vascular and cognitive response to exercise, dependent on the type of exercise, the physical fitness and the presence of menopausal symptoms. * Third, to examine the effect of menopausal symptoms, and physical fitness on cardio-neuro-vascular health markers and cognitive health markers.
Interventions
OTHERHigh intensity interval exercise session
Physical activity session supervised and adapted on ergometer
OTHERIsometric neuromuscular exercise session
Physical activity session supervised and adapted with a handgrip
Sponsors
University of Poitiers
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Menopausal women (absence of menstruation for 12 consecutive months) for less than 10 years * Women with or without vasomotor symptoms * Women covered by the French Social Security system
Exclusion criteria
* Surgical menopause (oophorectomy) * Premature ovarian failure * Chronic renal failure * Respiratory pathology (unstable asthma, respiratory insufficiency or pulmonary hypertension) * Cardiovascular disease (coronary, valvular, hypertrophic, hypertensive, infiltrative, constrictive or rhythmic) * Medically treated hypertension * Severe obesity (BMI \> 40 kg/m²) * Hearing or vision problems that prevent reading or distinguishing colors * Recent (\< 1 year) central neurological or psychiatric disorders * Moderate to severe cognitive impairment (MoCA \< 18). * Judicial protection or guardianship
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic and diastolic blood pressure (ambulatory blood pressure measurement) | After sessions (24 hours) | Post-exercise hypotension, using the Mobil-O-Graph (mmHg). |
| Systolic and diastolic blood pressure (resting) | Before and after sessions (15 minutes) | Automated oscillometric tensiometer (mmHg). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Height | Baseline (1 minute) | Height in meters measured with a height gauge. |
| Concentration of cerebral oxygenation | Before, during, and after sessions (1 hour) | Near-infrared spectroscopy is used to measure concentrations of oxygenated and desoxygenated hemoglobin (µmol/L). |
| Working memory | Before and after sessions (10 minutes) | 2-back task (scored from 0 to 28, higher scores indicate better working memory). |
| Episodic memory | 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). |
| Executive function | 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). |
| Perception of exertion | After sessions (1 minute) | Modified Borg scale (scored 0 to 10, higher score indicates lower exercise tolerance). |
| Endothelial function (brachial artery dilation capacity) | Baseline (30 minutes) | At rest, the flow-mediated dilatation technique is used with high-resolution Doppler ultrasound (CX-50 Philipps). |
| Baroreflex sensitivity | Baseline (1 hour) | At rest, baroreflex sensitivity is measured using the Finapres. |
| Aortic systolic and diastolic blood pressure | Baseline (15 minutes) | At rest, using the SphygmoCor device, which measures central blood pressure (mmHg). |
| Arterial stiffness (pulse wave velocity) | Baseline (15 minutes) | At rest, using the SphygmoCor device, which calculates carotid-femoral pulse wave velocity (m/s). |
| Physical fitness | Baseline (30 minutes) | Maximal cardiopulmonary effort test (VO2max). |
| Cognitive assessment | Baseline (15 minutes) | Montreal Cognitive Assessment (MoCA) test (scored from 0 to 30, with higher scores indicating better cognitive function). |
| Blood hormone concentrations | Baseline (5 minutes) | Progesterone, 17-beta-estradiol, and follicle-stimulating hormone (ng/L). |
| Body weight | Baseline (1 minute) | Total body weight, fat mass, fat-free mass and visceral-fat mass in kilograms using the Tanita impedance scale. |
| Body mass index | Baseline (1 minute) | Calculated from total body weight and height (kg/m²). |
| Menopausal rating scale | Baseline (15 minutes) | Composed of 11 items rating the severity of menopausal symptoms from 0 (no symptoms) to 4 (very severe). |
| Hot flash related daily interference scale | 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. |
| Hospital Anxiety and Depression Scale | Baseline (15 minutes) | It provides two scores ranging from 0 to 21 that quantify anxiety and depression. Higher scores indicate more severe symptoms. |
| Global physical activity questionnaire | 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). |
| Daily tobacco and alcohol use | Baseline | Use daily or not use. |
| Age | Baseline | Age, age at menarche and menopause (in years). |
| Educational level | Baseline | Secondary education, high school graduate, bachelor's degree, master's or doctoral degree. |
| Number of children | Baseline | Self-reported. |
| Blood lipid concentrations | Baseline (5 minutes) | Total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), and triglycerides (g/L). |
| Body composition | Baseline (1 minute) | Percentage of body fat and fat-free mass using the Tanita impedance scale. |
Countries
France
Outcome results
None listed