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

Primary Purpose

Cognitive Function, Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Walking exercise + resistance training
Resistance training
Walking exercise
Health promotion
Sponsored by
Beijing Sport University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Function focused on measuring Exercise intervention, Postmenopausal, Cognitive function, Hypertension

Eligibility Criteria

55 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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 b. 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

Sites / Locations

  • School of Sports Medicine and Rehabilitation, Beijing Sport UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Sham Comparator

Arm Label

Combined training group

Resistance training group

Walking exercise group

Positive control group

Negative control group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Blood pressure
The change of blood pressure before and after intervention.
Quiet heart rate
The change of quiet heart rate before and after intervention.
Waist and hip circumference
The change of waist circumference and hip circumference before and after intervention.
Body fat percentage
The change of body fat percentage before and after intervention.
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).
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.
Serum interleukin-6 (IL-6)
The change of inflammation indicators before and after intervention.
High-sensitivity C-reactive protein (hs-CRP)
The change of inflammation indicators before and after intervention.
Vascular endothelial growth factor (VEGF)
The change of growth factor indicators before and after intervention.
Insulin-like growth factor(IGF-1)
The change of growth factor indicators before and after intervention.
Malondialdehyde (MDA)
The change of malondialdehyde (MDA) level before and after intervention.
Superoxide dismutase (SOD)
The change of superoxide dismutase (SOD) level before and after intervention.
Nitric oxide (NO)
The change of nitric oxide (NO) level before and after intervention.
Heart rate variability (HRV)
The change of heart rate variability (HRV) before and after intervention.
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.
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.
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.
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.
Vascular endothelial function indicator: Flow-mediated dilation (FMD)
The change of flow-mediated dilation before and after intervention.
Artery stiffness indicator: Carotid-femoral pulse artery stiffness (cfPWV).
The change of carotid-femoral pulse artery stiffness (cfPWV) before and after intervention.

Full Information

First Posted
April 20, 2023
Last Updated
June 1, 2023
Sponsor
Beijing Sport University
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1. Study Identification

Unique Protocol Identification Number
NCT05898503
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 23, 2023 (Actual)
Primary Completion Date
April 23, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Sport University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Function, Hypertension
Keywords
Exercise intervention, Postmenopausal, Cognitive function, Hypertension

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
183 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combined training group
Arm Type
Experimental
Arm Title
Resistance training group
Arm Type
Experimental
Arm Title
Walking exercise group
Arm Type
Experimental
Arm Title
Positive control group
Arm Type
Active Comparator
Arm Title
Negative control group
Arm Type
Sham Comparator
Intervention Type
Behavioral
Intervention Name(s)
Walking exercise + resistance training
Intervention Description
Walking exercise and resistance training for 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Resistance training
Intervention Description
Resistance training for 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Walking exercise
Intervention Description
Walking exercise for 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Health promotion
Intervention Description
Health promotion for 12 weeks
Primary Outcome Measure Information:
Title
MOCA score
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Blood pressure
Description
The change of blood pressure before and after intervention.
Time Frame
12 weeks
Title
Quiet heart rate
Description
The change of quiet heart rate before and after intervention.
Time Frame
12 weeks
Title
Waist and hip circumference
Description
The change of waist circumference and hip circumference before and after intervention.
Time Frame
12 weeks
Title
Body fat percentage
Description
The change of body fat percentage before and after intervention.
Time Frame
12 weeks
Title
Lipid metabolism indicators
Description
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).
Time Frame
12 weeks
Title
Cardiorespiratory endurance indicator
Description
The change of cardiopulmonary endurance indicator before and after intervention. Cardiopulmonary endurance indicator: maximal oxygen uptake (VO2max) was determined using exercise cardiorespiratory testing system.
Time Frame
12 weeks
Title
Serum interleukin-6 (IL-6)
Description
The change of inflammation indicators before and after intervention.
Time Frame
12 weeks
Title
High-sensitivity C-reactive protein (hs-CRP)
Description
The change of inflammation indicators before and after intervention.
Time Frame
12 weeks
Title
Vascular endothelial growth factor (VEGF)
Description
The change of growth factor indicators before and after intervention.
Time Frame
12 weeks
Title
Insulin-like growth factor(IGF-1)
Description
The change of growth factor indicators before and after intervention.
Time Frame
12 weeks
Title
Malondialdehyde (MDA)
Description
The change of malondialdehyde (MDA) level before and after intervention.
Time Frame
12 weeks
Title
Superoxide dismutase (SOD)
Description
The change of superoxide dismutase (SOD) level before and after intervention.
Time Frame
12 weeks
Title
Nitric oxide (NO)
Description
The change of nitric oxide (NO) level before and after intervention.
Time Frame
12 weeks
Title
Heart rate variability (HRV)
Description
The change of heart rate variability (HRV) before and after intervention.
Time Frame
12 weeks
Title
Mean flow rate (Vm) of middle cerebral artery and carotid artery
Description
The change of middle cerebral artery mean flow rate and carotid artery mean flow rate before and after intervention.
Time Frame
12 weeks
Title
Resistance index (RI) of middle cerebral artery and carotid artery
Description
The change of middle cerebral artery resistance index and carotid artery resistance index before and after intervention.
Time Frame
12 weeks
Title
Pulsatility index (PI) of middle cerebral artery and carotid artery
Description
The change of middle cerebral artery pulsatility index and carotid artery pulsatility index before and after intervention.
Time Frame
12 weeks
Title
Peak systolic velocity (PSV) and end-diastolic velocity (EDV) of carotid artery
Description
The change of peak systolic velocity and end-diastolic velocity of carotid artery before and after intervention.
Time Frame
12 weeks
Title
Vascular endothelial function indicator: Flow-mediated dilation (FMD)
Description
The change of flow-mediated dilation before and after intervention.
Time Frame
12 weeks
Title
Artery stiffness indicator: Carotid-femoral pulse artery stiffness (cfPWV).
Description
The change of carotid-femoral pulse artery stiffness (cfPWV) before and after intervention.
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 b. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peizhen Zhang
Phone
01062989581
Email
zhpzh@bsu.edu.cn
Facility Information:
Facility Name
School of Sports Medicine and Rehabilitation, Beijing Sport University
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peizhen Zhang
Email
zhpzh@bsu.edu.cn
First Name & Middle Initial & Last Name & Degree
Peizhen Zhang

12. IPD Sharing Statement

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

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