Effect of Different Exercise Modalities on Cardiovascular and Cognitive Response in Postmenopausal Women
NCT Number: NCT06533982
Acronym: WOMEN-EX-MOD
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Menopause|Blood Pressure|Cognitive Decline
Interventions: OTHER: High intensity interval exercise session|OTHER: Isometric neuromuscular exercise session
Sponsor: University of Poitiers
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2023-03-10
Completion Date: 2023-12-20
Locations: Faculty of Sport Science - MOVE Laboratory (UR20296), Poitiers, 86000, France

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.

Primary Outcome Measures: Systolic and diastolic blood pressure (ambulatory blood pressure measurement), Post-exercise hypotension, using the Mobil-O-Graph (mmHg)., After sessions (24 hours)|Systolic and diastolic blood pressure (resting), Automated oscillometric tensiometer (mmHg)., Before and after sessions (15 minutes)
Secondary Outcome Measures: Concentration of cerebral oxygenation, Near-infrared spectroscopy is used to measure concentrations of oxygenated and desoxygenated hemoglobin (µmol/L)., Before, during, and after sessions (1 hour)|Working memory, 2-back task (scored from 0 to 28, higher scores indicate better working memory)., Before and after sessions (10 minutes)|Episodic memory, 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)., Before and after sessions (15 minutes)|Executive function, Stroop task, used to assess inhibitory control (scored as a ratio, negative score indicates worse inhibitory control vs. positive score indicates better inhibitory control)., Before and after sessions (15 minutes)|Perception of exertion, Modified Borg scale (scored 0 to 10, higher score indicates lower exercise tolerance)., After sessions (1 minute)|Endothelial function (brachial artery dilation capacity), At rest, the flow-mediated dilatation technique is used with high-resolution Doppler ultrasound (CX-50 Philipps)., Baseline (30 minutes)|Baroreflex sensitivity, At rest, baroreflex sensitivity is measured using the Finapres., Baseline (1 hour)|Aortic systolic and diastolic blood pressure, At rest, using the SphygmoCor device, which measures central blood pressure (mmHg)., Baseline (15 minutes)|Arterial stiffness (pulse wave velocity), At rest, using the SphygmoCor device, which calculates carotid-femoral pulse wave velocity (m/s)., Baseline (15 minutes)|Physical fitness, Maximal cardiopulmonary effort test (VO2max)., Baseline (30 minutes)|Blood lipid concentrations, Total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), and triglycerides (g/L)., Baseline (5 minutes)|Blood hormone concentrations, Progesterone, 17-beta-estradiol, and follicle-stimulating hormone (ng/L)., Baseline (5 minutes)|Body weight, Total body weight, fat mass, fat-free mass and visceral-fat mass in kilograms using the Tanita impedance scale., Baseline (1 minute)|Body composition, Percentage of body fat and fat-free mass using the Tanita impedance scale., Baseline (1 minute)|Height, Height in meters measured with a height gauge., Baseline (1 minute)|Body mass index, Calculated from total body weight and height (kg/m²)., Baseline (1 minute)|Cognitive assessment, Montreal Cognitive Assessment (MoCA) test (scored from 0 to 30, with higher scores indicating better cognitive function)., Baseline (15 minutes)|Menopausal rating scale, Composed of 11 items rating the severity of menopausal symptoms from 0 (no symptoms) to 4 (very severe)., Baseline (15 minutes)|Hot flash related daily interference scale, Composed of 10 items scored from 0 (no impact) to 10 (completely interferes), evaluating the impact of vasomotor symptoms on daily life., Baseline (15 minutes)|Hospital Anxiety and Depression Scale, It provides two scores ranging from 0 to 21 that quantify anxiety and depression. Higher scores indicate more severe symptoms., Baseline (15 minutes)|Global physical activity questionnaire, 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)., Baseline (15 minutes)|Daily tobacco and alcohol use, Use daily or not use., Baseline|Age, Age, age at menarche and menopause (in years)., Baseline|Educational level, Secondary education, high school graduate, bachelor's degree, master's or doctoral degree., Baseline|Number of children, Self-reported., Baseline