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

June 1, 2023 updated by: Beijing Sport University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

183

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • School of Sports Medicine and Rehabilitation, Beijing Sport University
        • Contact:
        • Principal Investigator:
          • Peizhen Zhang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MOCA score
Time Frame: 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.
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Sport University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2023

Primary Completion (Estimated)

April 23, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

April 20, 2023

First Submitted That Met QC Criteria

June 1, 2023

First Posted (Actual)

June 12, 2023

Study Record Updates

Last Update Posted (Actual)

June 12, 2023

Last Update Submitted That Met QC Criteria

June 1, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EODTOEOCFIPHW

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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