Effect of Different Exercise Modalities on Cardiovascular and Cognitive Response in Postmenopausal Women

Not Applicable

Completed

• Conditions: Menopause; Blood Pressure; Cognitive Decline
• Interventions: Other: Isometric neuromuscular exercise session; Other: High intensity interval exercise session

• Registration Number: NCT06533982
• Lead Sponsor: University of Poitiers

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.

Study Timeline

• Study Start: 2023-03-10
• Primary Completion: 2023-03-28
• Study Completion: 2023-12-20
• Status Verified: 2024-07
• Study First Submitted: 2024-07-19
• Study First Submitted QC: 2024-07-31
• Last Update Submitted: 2024-07-31
• Study First Posted: 2024-08-01
• Last Update Posted: 2024-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Isometric neuromuscular exercise session	Isometric neuromuscular exercise session	Performed with a handgrip (K-Force grip, KINVENT), the intensity of the session is adapted to the participant's capacity, initially assessed by the isometric maximal voluntary force (MVF) measurement at the beginning of the session. The session consists of 4 repetitions of 2 minutes at 30% of the isometric MVF, separated by 1 minute recovery.
High intensity interval exercise session	High intensity interval exercise session	Performed on an ergometer, the intensity of the session is adapted to the participant's physical capacity, initially assessed by the VO2max test at baseline. The session begins with a 5-minute warm-up at 50% of maximum aerobic power (MAP). The exercise then consists of 2 sets of 12 repetitions of 15 seconds each at 100% of MAP and 15 seconds of passive recovery. 2-minute of passive recovery is recommended between the two sets. The session ends with 5-minute of recovery at 50% of MAP.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Working memory	Before and after sessions (10 minutes)	2-back task (scored from 0 to 28, higher scores indicate better working memory).
Baroreflex sensitivity	Baseline (1 hour)	At rest, baroreflex sensitivity is measured using the Finapres.
Blood hormone concentrations	Baseline (5 minutes)	Progesterone, 17-beta-estradiol, and follicle-stimulating hormone (ng/L).
Daily tobacco and alcohol use	Baseline	Use daily or not use.
Educational level	Baseline	Secondary education, high school graduate, bachelor's degree, master's or doctoral degree.
Number of children	Baseline	Self-reported.
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).
Arterial stiffness (pulse wave velocity)	Baseline (15 minutes)	At rest, using the SphygmoCor device, which calculates carotid-femoral pulse wave velocity (m/s).
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.
Age	Baseline	Age, age at menarche and menopause (in years).
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).
Perception of exertion	After sessions (1 minute)	Modified Borg scale (scored 0 to 10, higher score indicates lower exercise tolerance).
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).
Aortic systolic and diastolic blood pressure	Baseline (15 minutes)	At rest, using the SphygmoCor device, which measures central blood pressure (mmHg).
Physical fitness	Baseline (30 minutes)	Maximal cardiopulmonary effort test (VO2max).
Height	Baseline (1 minute)	Height in meters measured with a height gauge.
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.
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).
Blood lipid concentrations	Baseline (5 minutes)	Total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), and triglycerides (g/L).
Cognitive assessment	Baseline (15 minutes)	Montreal Cognitive Assessment (MoCA) test (scored from 0 to 30, with higher scores indicating better cognitive function).
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).
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 composition	Baseline (1 minute)	Percentage of body fat and fat-free mass using the Tanita impedance scale.

Trial Locations

Locations (1)

Faculty of Sport Science - MOVE Laboratory (UR20296); 🇫🇷 Poitiers, France