Clinical trial NCT06533982: Effect of Different Exercise Modalities on Cardiovascular and Cognitive Response in Postmenopausal Women
Official title: Effect of Different Exercise Modalities on Cardiovascular and Cognitive Response in Postmenopausal Women With and Without Vasomotor Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Blood Pressure
Cognitive Decline
Keywords: Physical exercise
High intensity interval exercise
Handgrip
Lead sponsor: University of Poitiers
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 30
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Systolic and diastolic blood pressure (ambulatory blood pressure measurement)
timeFrame: After sessions (24 hours)
measure: Systolic and diastolic blood pressure (resting)
timeFrame: Before and after sessions (15 minutes)
Secondary outcomes:
measure: Concentration of cerebral oxygenation
timeFrame: Before, during, and after sessions (1 hour)
measure: Working memory
timeFrame: Before and after sessions (10 minutes)
measure: Episodic memory
timeFrame: Before and after sessions (15 minutes)
measure: Executive function
timeFrame: Before and after sessions (15 minutes)
measure: Perception of exertion
timeFrame: After sessions (1 minute)
measure: Endothelial function (brachial artery dilation capacity)
timeFrame: Baseline (30 minutes)
measure: Baroreflex sensitivity
timeFrame: Baseline (1 hour)
measure: Aortic systolic and diastolic blood pressure
timeFrame: Baseline (15 minutes)
measure: Arterial stiffness (pulse wave velocity)
timeFrame: Baseline (15 minutes)
measure: Physical fitness
timeFrame: Baseline (30 minutes)
measure: Blood lipid concentrations
timeFrame: Baseline (5 minutes)
measure: Blood hormone concentrations
timeFrame: Baseline (5 minutes)
measure: Body weight
timeFrame: Baseline (1 minute)
measure: Body composition
timeFrame: Baseline (1 minute)
measure: Height
timeFrame: Baseline (1 minute)
measure: Body mass index
timeFrame: Baseline (1 minute)
measure: Cognitive assessment
timeFrame: Baseline (15 minutes)
measure: Menopausal rating scale
timeFrame: Baseline (15 minutes)
measure: Hot flash related daily interference scale
timeFrame: Baseline (15 minutes)
measure: Hospital Anxiety and Depression Scale
timeFrame: Baseline (15 minutes)
measure: Global physical activity questionnaire
timeFrame: Baseline (15 minutes)
measure: Daily tobacco and alcohol use
timeFrame: Baseline
measure: Age
timeFrame: Baseline
measure: Educational level
timeFrame: Baseline
measure: Number of children
timeFrame: Baseline
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Faculty of Sport Science - MOVE Laboratory (UR20296)
Study officials:
affiliation: University of Poitiers - Faculty of Sport Science - MOVE Laboratory (UR20296)
name: Laurent Bosquet, Pr
role: PRINCIPAL_INVESTIGATOR
References:
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