Effect of Different Exercise Modalities on Cardiovascular and Cognitive Response in Postmenopausal Women (WOMEN-EX-MOD)

University of Poitiers

Status: Completed

Conditions: Menopause; Cognitive Decline; Blood Pressure

Treatments: Other: High intensity interval exercise session; Other: Isometric neuromuscular exercise session

Study type: Interventional

Funder types: Other

Identifiers

NCT06533982

WOMEN-EX-MOD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 3 patient groups

High intensity interval exercise session

Experimental group

Description:

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.

Treatment:

Other: High intensity interval exercise session

Isometric neuromuscular exercise session

Experimental group

Description:

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.

Treatment:

Other: Isometric neuromuscular exercise session

Control session

No Intervention group

Description:

Participants are seated for 30 minutes.