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

Sponsor

Beijing Sport University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05898503

Collaborator

(none)

183

Enrollment

Location

Arms

20.3

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cognitive Function Hypertension	Behavioral: Walking exercise + resistance training Behavioral: Resistance training Behavioral: Walking exercise Behavioral: Health promotion	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

183 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Apr 23, 2023

Anticipated Primary Completion Date :

Apr 23, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Combined training group	Behavioral: Walking exercise + resistance training Walking exercise and resistance training for 12 weeks
Experimental: Resistance training group	Behavioral: Resistance training Resistance training for 12 weeks
Experimental: Walking exercise group	Behavioral: Walking exercise Walking exercise for 12 weeks
Active Comparator: Positive control group	Behavioral: Health promotion Health promotion for 12 weeks
Sham Comparator: Negative control group	Behavioral: Health promotion Health promotion for 12 weeks

Outcome Measures

Primary Outcome Measures

MOCA score [12 weeks]
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.

Secondary Outcome Measures

Blood pressure [12 weeks]
The change of blood pressure before and after intervention.
Quiet heart rate [12 weeks]
The change of quiet heart rate before and after intervention.
Waist and hip circumference [12 weeks]
The change of waist circumference and hip circumference before and after intervention.
Body fat percentage [12 weeks]
The change of body fat percentage before and after intervention.
Lipid metabolism indicators [12 weeks]
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).
Cardiorespiratory endurance indicator [12 weeks]
The change of cardiopulmonary endurance indicator before and after intervention. Cardiopulmonary endurance indicator: maximal oxygen uptake (VO2max) was determined using exercise cardiorespiratory testing system.
Serum interleukin-6 (IL-6) [12 weeks]
The change of inflammation indicators before and after intervention.
High-sensitivity C-reactive protein (hs-CRP) [12 weeks]
The change of inflammation indicators before and after intervention.
Vascular endothelial growth factor (VEGF) [12 weeks]
The change of growth factor indicators before and after intervention.
Insulin-like growth factor(IGF-1) [12 weeks]
The change of growth factor indicators before and after intervention.
Malondialdehyde (MDA) [12 weeks]
The change of malondialdehyde (MDA) level before and after intervention.
Superoxide dismutase (SOD) [12 weeks]
The change of superoxide dismutase (SOD) level before and after intervention.
Nitric oxide (NO) [12 weeks]
The change of nitric oxide (NO) level before and after intervention.
Heart rate variability (HRV) [12 weeks]
The change of heart rate variability (HRV) before and after intervention.
Mean flow rate (Vm) of middle cerebral artery and carotid artery [12 weeks]
The change of middle cerebral artery mean flow rate and carotid artery mean flow rate before and after intervention.
Resistance index (RI) of middle cerebral artery and carotid artery [12 weeks]
The change of middle cerebral artery resistance index and carotid artery resistance index before and after intervention.
Pulsatility index (PI) of middle cerebral artery and carotid artery [12 weeks]
The change of middle cerebral artery pulsatility index and carotid artery pulsatility index before and after intervention.
Peak systolic velocity (PSV) and end-diastolic velocity (EDV) of carotid artery [12 weeks]
The change of peak systolic velocity and end-diastolic velocity of carotid artery before and after intervention.
Vascular endothelial function indicator: Flow-mediated dilation (FMD) [12 weeks]
The change of flow-mediated dilation before and after intervention.
Artery stiffness indicator: Carotid-femoral pulse artery stiffness (cfPWV). [12 weeks]
The change of carotid-femoral pulse artery stiffness (cfPWV) before and after intervention.

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

postmenopausal HTN women aged 55 to 65 years
140 mm Hg ≤ SBP < 160 mm Hg) and/or 90 mmHg < DBP < 99 mmHg (2016 edition of the Chinese guidelines for hypertension control)
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
no other metabolic and cardiovascular problems
able to participate in physical activity
no exercise habit (no more than 6,000 steps per day)
alcohol and smoking prohibited
moderate risk classification of having cardiovascular disease
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

Inclusion criteria for the negative control group:

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

Exclusion criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	School of Sports Medicine and Rehabilitation, Beijing Sport University	Beijing		China

Sponsors and Collaborators

Beijing Sport University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Beijing Sport University

ClinicalTrials.gov Identifier:

NCT05898503

Other Study ID Numbers:

EODTOEOCFIPHW

First Posted:

Jun 12, 2023

Last Update Posted:

Jun 12, 2023

Last Verified:

Apr 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Beijing Sport University

Exercise intervention

Postmenopausal

Cognitive function

Hypertension

Additional relevant MeSH terms:

Hypertension

Study Results

No Results Posted as of Jun 12, 2023