Cognitive FunctionNCT05898503
Effects of Different Types of Exercise on Cognitive Function in Postmenopausal Hypertensive Women
A study testing Walking exercise + resistance training, Resistance training and Walking exercise in people with Cognitive Function and Hypertension, run by Beijing Sport University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 55 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function, Hypertension
- What is being tested?
- Walking exercise + resistance training, Resistance training and Walking exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 183 participants
- Where
- 1 siteChina
- Study dates
- 23 Apr 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
School of Sports Medicine and Rehabilitation, Beijing Sport University
Beijing
Peizhen Zhang, zhpzh@bsu.edu.cn
Peizhen Zhang
About this study
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.
Read the 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.
- Conditions
- Cognitive Function, Hypertension
- Being tested
- Walking exercise + resistance training, Resistance training, Walking exercise, Health promotion
- Keywords
- Exercise intervention, Postmenopausal, Cognitive function, Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking exercise + resistance trainingBehavioural
Walking exercise and resistance training for 12 weeks
Resistance trainingBehavioural
Resistance training for 12 weeks
Walking exerciseBehavioural
Walking exercise for 12 weeks
Health promotionBehavioural
Health promotion for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Combined training group | Experimental | Not described Receives: Behavioral: Walking exercise + resistance training |
| Resistance training group | Experimental | Not described Receives: Behavioral: Resistance training |
| Walking exercise group | Experimental | Not described Receives: Behavioral: Walking exercise |
| Positive control group | Active comparator | Not described Receives: Behavioral: Health promotion |
| Negative control group | Sham comparator | Not described Receives: Behavioral: Health promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (20)
Blood pressure
The change of blood pressure before and after intervention.
Measured: 12 weeks
Quiet heart rate
The change of quiet heart rate before and after intervention.
Measured: 12 weeks
Waist and hip circumference
The change of waist circumference and hip circumference before and after intervention.
Measured: 12 weeks
Body fat percentage
The change of body fat percentage before and after intervention.
Measured: 12 weeks
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).
Measured: 12 weeks
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.
Measured: 12 weeks
Serum interleukin-6 (IL-6)
The change of inflammation indicators before and after intervention.
Measured: 12 weeks
High-sensitivity C-reactive protein (hs-CRP)
The change of inflammation indicators before and after intervention.
Measured: 12 weeks
Vascular endothelial growth factor (VEGF)
The change of growth factor indicators before and after intervention.
Measured: 12 weeks
Insulin-like growth factor(IGF-1)
The change of growth factor indicators before and after intervention.
Measured: 12 weeks
Malondialdehyde (MDA)
The change of malondialdehyde (MDA) level before and after intervention.
Measured: 12 weeks
Superoxide dismutase (SOD)
The change of superoxide dismutase (SOD) level before and after intervention.
Measured: 12 weeks
Nitric oxide (NO)
The change of nitric oxide (NO) level before and after intervention.
Measured: 12 weeks
Heart rate variability (HRV)
The change of heart rate variability (HRV) before and after intervention.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Vascular endothelial function indicator: Flow-mediated dilation (FMD)
The change of flow-mediated dilation before and after intervention.
Measured: 12 weeks
Artery stiffness indicator: Carotid-femoral pulse artery stiffness (cfPWV).
The change of carotid-femoral pulse artery stiffness (cfPWV) before and after intervention.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start23 Apr 2023
- Primary completion23 Apr 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 183 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Sport University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05898503
- Sponsor's protocol ID
- EODTOEOCFIPHW
- Status last verified
- Apr 2023
- First submitted
- 20 Apr 2023
- Last updated
- 12 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Types of Exercise on Cognitive Function in Postmenopausal Hypertensive Women
- ClinicalTrials.gov ID
- NCT05898503
- Acronym / sponsor ID
- EODTOEOCFIPHW
- Conditions
- Cognitive Function, Hypertension
- Keywords
- Exercise intervention, Postmenopausal, Cognitive function, Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 183 participants (estimated)
- Lead sponsor
- Beijing Sport UniversityUniversity, hospital or other
- Study start
- 23 Apr 2023 (actual)
- Primary completion
- 23 Apr 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Combined training group | Experimental | Behavioral: Walking exercise + resistance training |
| Resistance training group | Experimental | Behavioral: Resistance training |
| Walking exercise group | Experimental | Behavioral: Walking exercise |
| Positive control group | Active comparator | Behavioral: Health promotion |
| Negative control group | Sham comparator | Behavioral: Health promotion |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
- pre-menopausal and not in the above category
- SBP and DBP values below normal
- general health, disability or other medical conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walking exercise + resistance trainingWalking exercise and resistance training for 12 weeks | Behavioural | Combined training group |
| Resistance trainingResistance training for 12 weeks | Behavioural | Resistance training group |
| Walking exerciseWalking exercise for 12 weeks | Behavioural | Walking exercise group |
| Health promotionHealth promotion for 12 weeks | Behavioural | Negative control group, Positive control group |
Primary outcome
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.
20 secondary outcomes
Blood pressure
Time frame: 12 weeks
Quiet heart rate
Time frame: 12 weeks
Waist and hip circumference
Time frame: 12 weeks
Body fat percentage
Time frame: 12 weeks
Lipid metabolism indicators
Time frame: 12 weeks
Cardiorespiratory endurance indicator
Time frame: 12 weeks
Serum interleukin-6 (IL-6)
Time frame: 12 weeks
High-sensitivity C-reactive protein (hs-CRP)
Time frame: 12 weeks
Vascular endothelial growth factor (VEGF)
Time frame: 12 weeks
Insulin-like growth factor(IGF-1)
Time frame: 12 weeks
Malondialdehyde (MDA)
Time frame: 12 weeks
Superoxide dismutase (SOD)
Time frame: 12 weeks
Nitric oxide (NO)
Time frame: 12 weeks
Heart rate variability (HRV)
Time frame: 12 weeks
Mean flow rate (Vm) of middle cerebral artery and carotid artery
Time frame: 12 weeks
Resistance index (RI) of middle cerebral artery and carotid artery
Time frame: 12 weeks
Pulsatility index (PI) of middle cerebral artery and carotid artery
Time frame: 12 weeks
Peak systolic velocity (PSV) and end-diastolic velocity (EDV) of carotid artery
Time frame: 12 weeks
Vascular endothelial function indicator: Flow-mediated dilation (FMD)
Time frame: 12 weeks
Artery stiffness indicator: Carotid-femoral pulse artery stiffness (cfPWV).
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking exercise + resistance training, Resistance training and Walking exercise in people with Cognitive Function and Hypertension, run by Beijing Sport University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peizhen Zhang (01062989581, zhpzh@bsu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MOCA score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023.