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Completed

NCT Number: NCT06533982

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

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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Key information

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Sport Science - MOVE Laboratory (UR20296)

Poitiers, 86000, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High intensity interval exercise session

Other

Physical activity session supervised and adapted on ergometer

Isometric neuromuscular exercise session

Other

Physical activity session supervised and adapted with a handgrip

Primary outcomes

  1. Systolic and diastolic blood pressure (ambulatory blood pressure measurement)

    Time frame: After sessions (24 hours)

    Post-exercise hypotension, using the Mobil-O-Graph (mmHg).

  2. Systolic and diastolic blood pressure (resting)

    Time frame: Before and after sessions (15 minutes)

    Automated oscillometric tensiometer (mmHg).

Secondary outcomes

  1. Concentration of cerebral oxygenation

    Time frame: Before, during, and after sessions (1 hour)

    Near-infrared spectroscopy is used to measure concentrations of oxygenated and desoxygenated hemoglobin (µmol/L).

  2. Working memory

    Time frame: Before and after sessions (10 minutes)

    2-back task (scored from 0 to 28, higher scores indicate better working memory).

  3. Episodic 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).

  4. Executive function

    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).

  5. Perception of exertion

    Time frame: After sessions (1 minute)

    Modified Borg scale (scored 0 to 10, higher score indicates lower exercise tolerance).

  6. Endothelial function (brachial artery dilation capacity)

    Time frame: Baseline (30 minutes)

    At rest, the flow-mediated dilatation technique is used with high-resolution Doppler ultrasound (CX-50 Philipps).

  7. Baroreflex sensitivity

    Time frame: Baseline (1 hour)

    At rest, baroreflex sensitivity is measured using the Finapres.

  8. Aortic systolic and diastolic blood pressure

    Time frame: Baseline (15 minutes)

    At rest, using the SphygmoCor device, which measures central blood pressure (mmHg).

  9. Arterial stiffness (pulse wave velocity)

    Time frame: Baseline (15 minutes)

    At rest, using the SphygmoCor device, which calculates carotid-femoral pulse wave velocity (m/s).

  10. Physical fitness

    Time frame: Baseline (30 minutes)

    Maximal cardiopulmonary effort test (VO2max).

  11. Blood lipid concentrations

    Time frame: Baseline (5 minutes)

    Total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), and triglycerides (g/L).

  12. Blood hormone concentrations

    Time frame: Baseline (5 minutes)

    Progesterone, 17-beta-estradiol, and follicle-stimulating hormone (ng/L).

  13. Body weight

    Time frame: Baseline (1 minute)

    Total body weight, fat mass, fat-free mass and visceral-fat mass in kilograms using the Tanita impedance scale.

  14. Body composition

    Time frame: Baseline (1 minute)

    Percentage of body fat and fat-free mass using the Tanita impedance scale.

  15. Height

    Time frame: Baseline (1 minute)

    Height in meters measured with a height gauge.

  16. Body mass index

    Time frame: Baseline (1 minute)

    Calculated from total body weight and height (kg/m²).

  17. Cognitive assessment

    Time frame: Baseline (15 minutes)

    Montreal Cognitive Assessment (MoCA) test (scored from 0 to 30, with higher scores indicating better cognitive function).

  18. Menopausal rating scale

    Time frame: Baseline (15 minutes)

    Composed of 11 items rating the severity of menopausal symptoms from 0 (no symptoms) to 4 (very severe).

  19. Hot flash related daily interference scale

    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.

  20. Hospital Anxiety and Depression Scale

    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.

  21. Global physical activity questionnaire

    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).

  22. Daily tobacco and alcohol use

    Time frame: Baseline

    Use daily or not use.

  23. Age

    Time frame: Baseline

    Age, age at menarche and menopause (in years).

  24. Educational level

    Time frame: Baseline

    Secondary education, high school graduate, bachelor's degree, master's or doctoral degree.

  25. Number of children

    Time frame: Baseline

    Self-reported.

Sponsors and collaborators

Lead sponsor

University of Poitiers

Other

Registry information

Official study title

Effect of Different Exercise Modalities on Cardiovascular and Cognitive Response in Postmenopausal Women With and Without Vasomotor Symptoms

Acronym: WOMEN-EX-MOD

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 1, 2024
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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