Clinical trial NCT05898503: Effects of Different Types of Exercise on Cognitive Function in Postmenopausal Hypertensive Women
Official title: Effects of Different Types of Exercise on Cognitive Function in Postmenopausal Hypertensive Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Function
Hypertension
Keywords: Exercise intervention
Postmenopausal
Cognitive function
Hypertension
Lead sponsor: Beijing Sport University
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 183
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Brief Summary: The study was conducted in two parts, the first of which was carried out using a cross-sectional design approach to explore the relationship between cognitive function and autonomic function, brain function, inflammation and oxidative stress, vascular function, fitness levels, cardiorespiratory endurance and lipid metabolism. The second part uses a repeated measures design approach in a randomised controlled design to explore the effects of different types of exercise on cognitive decline in postmenopausal hypertensive women and their mechanisms of action.

Detailed description: Detailed Description: The study was conducted in 2 parts. Part I: was conducted using a cross-sectional design approach to explore the relationship between cognitive function and autonomic function, brain function, inflammation and oxidative stress, vascular function, fitness levels, cardiorespiratory endurance and lipid metabolism. Multiple linear regression was used to analyse the multiple linear relationships between changes in cognitive function and the above influences. Multiple logistic regression analysis was also used to analyse which of the above risk factors might be independent predictors of cognitive decline. Therefore, a combination of both regression analyses was used to further explore the multiple linear relationships between cognitive function and the aforementioned influencing factors, providing a viable causal and theoretical basis for the next exercise intervention.

The second part of the study is to test the viability of the vascular function theory. The "vascular function theory" refers to the use of exercise to improve aerobic capacity, improve blood circulation to the heart, and improve cerebrovascular function, which in turn improves cognitive function. Based on the above hypothesis, this study aims to investigate the possible effects of 12 weeks of different types of exercise on cognitive decline in post-menopausal women with HTN, and to lay the theoretical and practical foundation for the extension of the exercise intervention to other ages and populations.

Eligibility criteria: 1. postmenopausal HTN women aged 55 to 65 years
2. 140 mm Hg ≤ SBP \< 160 mm Hg) and/or 90 mmHg \< DBP \< 99 mmHg (2016 edition of the Chinese guidelines for hypertension control)
3. non-persistent hypertension (i.e., continuous use of three or more antihypertensive drugs and blood pressure still within the normal range, or continuous use of four or more antihypertensive drugs to control blood pressure
4. no other metabolic and cardiovascular problems
5. able to participate in physical activity
6. no exercise habit (no more than 6,000 steps per day)
7. alcohol and smoking prohibited
8. moderate risk classification of having cardiovascular disease
9. voluntary participation

Exclusion criteria:

1 pre-menopausal, not falling under the above conditions 2 blood pressure not exceeding the above range 3 refractory hypertension and secondary hypertension 4 metabolic and cardiovascular diseases 5 unable to exercise for their own reasons 6 regular exercise (more than 6,000 steps per day) 7 poor lifestyle habits such as alcohol and smoking 8 suffering from cardiovascular disease risk classification of high or low

b.

Inclusion criteria for the negative control group:

1. postmenopausal women aged 55 to 65 years
2. SBP ≥ 120 mmHg, DBP \< 90 mmHg
3. good physical condition
4. practice daily exercise (more than 6000 times daily)
5. do not drink or smoke
6. have a risk classification of no risk for cardiovascular disease
7. voluntary participation

Exclusion criteria:

1. pre-menopausal and not in the above category
2. SBP and DBP values below normal
3. general health, disability or other medical conditions
4. poor diet, alcohol abuse, smoking, etc.
5. no low risk cardiovascular risk classification

Primary outcomes:
measure: MOCA score
timeFrame: 12 weeks
Secondary outcomes:
measure: Blood pressure
timeFrame: 12 weeks
measure: Quiet heart rate
timeFrame: 12 weeks
measure: Waist and hip circumference
timeFrame: 12 weeks
measure: Body fat percentage
timeFrame: 12 weeks
measure: Lipid metabolism indicators
timeFrame: 12 weeks
measure: Cardiorespiratory endurance indicator
timeFrame: 12 weeks
measure: Serum interleukin-6 (IL-6)
timeFrame: 12 weeks
measure: High-sensitivity C-reactive protein (hs-CRP)
timeFrame: 12 weeks
measure: Vascular endothelial growth factor (VEGF)
timeFrame: 12 weeks
measure: Insulin-like growth factor(IGF-1)
timeFrame: 12 weeks
measure: Malondialdehyde (MDA)
timeFrame: 12 weeks
measure: Superoxide dismutase (SOD)
timeFrame: 12 weeks
measure: Nitric oxide (NO)
timeFrame: 12 weeks
measure: Heart rate variability (HRV)
timeFrame: 12 weeks
measure: Mean flow rate (Vm) of middle cerebral artery and carotid artery
timeFrame: 12 weeks
measure: Resistance index (RI) of middle cerebral artery and carotid artery
timeFrame: 12 weeks
measure: Pulsatility index (PI) of middle cerebral artery and carotid artery
timeFrame: 12 weeks
measure: Peak systolic velocity (PSV) and end-diastolic velocity (EDV) of carotid artery
timeFrame: 12 weeks
measure: Vascular endothelial function indicator: Flow-mediated dilation (FMD)
timeFrame: 12 weeks
measure: Artery stiffness indicator: Carotid-femoral pulse artery stiffness (cfPWV).
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: School of Sports Medicine and Rehabilitation, Beijing Sport University
Study officials:
References: