Effect of Different Exercise Modalities on Cardiovascular and Cognitive Response in Postmenopausal Women With and Without Vasomotor Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Systolic and diastolic blood pressure (ambulatory blood pressure measurement)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Systolic and diastolic blood pressure (ambulatory blood pressure measurement)
时间窗: After sessions (24 hours)
Post-exercise hypotension, using the Mobil-O-Graph (mmHg).
Systolic and diastolic blood pressure (resting)
时间窗: Before and after sessions (15 minutes)
Automated oscillometric tensiometer (mmHg).
次要结局
- Working memory(Before and after sessions (10 minutes))
- Baroreflex sensitivity(Baseline (1 hour))
- Blood hormone concentrations(Baseline (5 minutes))
- Daily tobacco and alcohol use(Baseline)
- Educational level(Baseline)
- Number of children(Baseline)
- Executive function(Before and after sessions (15 minutes))
- Arterial stiffness (pulse wave velocity)(Baseline (15 minutes))
- Hospital Anxiety and Depression Scale(Baseline (15 minutes))
- Age(Baseline)
- Concentration of cerebral oxygenation(Before, during, and after sessions (1 hour))
- Perception of exertion(After sessions (1 minute))
- Episodic memory(Before and after sessions (15 minutes))
- Aortic systolic and diastolic blood pressure(Baseline (15 minutes))
- Physical fitness(Baseline (30 minutes))
- Height(Baseline (1 minute))
- Body mass index(Baseline (1 minute))
- Menopausal rating scale(Baseline (15 minutes))
- Hot flash related daily interference scale(Baseline (15 minutes))
- Endothelial function (brachial artery dilation capacity)(Baseline (30 minutes))
- Blood lipid concentrations(Baseline (5 minutes))
- Cognitive assessment(Baseline (15 minutes))
- Global physical activity questionnaire(Baseline (15 minutes))
- Body weight(Baseline (1 minute))
- Body composition(Baseline (1 minute))
研究者
Laurent Bosquet
Director
University of Poitiers