Effects of Different Types of Exercise on Cognitive Function in Postmenopausal Hypertensive Women

Hypertension Clinical Trial

Official title:

Effects of Different Types of Exercise on Cognitive Function in Postmenopausal Hypertensive Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05898503
• Other study ID #: EODTOEOCFIPHW
• Status: Recruiting
• Phase: N/A
• Start date: April 23, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: Beijing Sport University
• Contact: Peizhen Zhang
• Phone: 01062989581
• Email: zhpzh[@]bsu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 183
• Est. completion date: December 31, 2024
• Est. primary completion date: April 23, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 55 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Function
• Hypertension

Intervention

Behavioral:
• Walking exercise + resistance training
Walking exercise and resistance training for 12 weeks
• Resistance training
Resistance training for 12 weeks
• Walking exercise
Walking exercise for 12 weeks
• Health promotion
Health promotion for 12 weeks

Locations

Country	Name	City	State
China	School of Sports Medicine and Rehabilitation, Beijing Sport University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Sport University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MOCA score	The change of MOCA score. Montreal cognitive assessment (MoCA). The MoCA scale includes cognitive functions such as visuospatial and executive functions, naming, attention, language, abstraction, delayed recall and orientation, and evaluates the level of cognitive function from several cognitive dimensions. The MoCA has a total score of 30 questions, with 26 being normal and <26 being cognitive decline.	12 weeks
Secondary	Blood pressure	The change of blood pressure before and after intervention.	12 weeks
Secondary	Quiet heart rate	The change of quiet heart rate before and after intervention.	12 weeks
Secondary	Waist and hip circumference	The change of waist circumference and hip circumference before and after intervention.	12 weeks
Secondary	Body fat percentage	The change of body fat percentage before and after intervention.	12 weeks
Secondary	Lipid metabolism indicators	The change of lipid metabolism indicators before and after intervention. Lipid metabolism indicators include: total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C).	12 weeks
Secondary	Cardiorespiratory endurance indicator	The change of cardiopulmonary endurance indicator before and after intervention. Cardiopulmonary endurance indicator: maximal oxygen uptake (VO2max) was determined using exercise cardiorespiratory testing system.	12 weeks
Secondary	Serum interleukin-6 (IL-6)	The change of inflammation indicators before and after intervention.	12 weeks
Secondary	High-sensitivity C-reactive protein (hs-CRP)	The change of inflammation indicators before and after intervention.	12 weeks
Secondary	Vascular endothelial growth factor (VEGF)	The change of growth factor indicators before and after intervention.	12 weeks
Secondary	Insulin-like growth factor(IGF-1)	The change of growth factor indicators before and after intervention.	12 weeks
Secondary	Malondialdehyde (MDA)	The change of malondialdehyde (MDA) level before and after intervention.	12 weeks
Secondary	Superoxide dismutase (SOD)	The change of superoxide dismutase (SOD) level before and after intervention.	12 weeks
Secondary	Nitric oxide (NO)	The change of nitric oxide (NO) level before and after intervention.	12 weeks
Secondary	Heart rate variability (HRV)	The change of heart rate variability (HRV) before and after intervention.	12 weeks
Secondary	Mean flow rate (Vm) of middle cerebral artery and carotid artery	The change of middle cerebral artery mean flow rate and carotid artery mean flow rate before and after intervention.	12 weeks
Secondary	Resistance index (RI) of middle cerebral artery and carotid artery	The change of middle cerebral artery resistance index and carotid artery resistance index before and after intervention.	12 weeks
Secondary	Pulsatility index (PI) of middle cerebral artery and carotid artery	The change of middle cerebral artery pulsatility index and carotid artery pulsatility index before and after intervention.	12 weeks
Secondary	Peak systolic velocity (PSV) and end-diastolic velocity (EDV) of carotid artery	The change of peak systolic velocity and end-diastolic velocity of carotid artery before and after intervention.	12 weeks
Secondary	Vascular endothelial function indicator: Flow-mediated dilation (FMD)	The change of flow-mediated dilation before and after intervention.	12 weeks
Secondary	Artery stiffness indicator: Carotid-femoral pulse artery stiffness (cfPWV).	The change of carotid-femoral pulse artery stiffness (cfPWV) before and after intervention.	12 weeks