Vascular HealthNCT06201312
Effects of Crossover Point Exercise on Vascular Function of Women in Different Menopausal Years
A study testing COP exercise in people with Vascular Health, run by Beijing Sport University at 1 site in China.
Trial summary
Recruit postmenopausal women and randomly assign them to one of four groups: Early Postmenopausal Exercise Group (EE), Late Postmenopausal Exercise Group (LE), Early Postmenopausal Control Group (EC), and Late Postmenopausal Control Group (LC). Read more about this study
- Who is it for?
- Ages 45 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vascular Health
- What is being tested?
- COP exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 11 Dec 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 45 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women without cardiovascular disease
Who cannot join
- Women with undetermined menopause
- BMI <18.5 kg/m2 or BMI >28 kg/m2
- fasting plasma triglyceride levels ≥500 mgdl
- diabetes mellitus or fasting glucose >140 mgd
- blood creatinine >2.0 mgdl
- uncontrolled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >110 mmHg)
Show all 11Show fewer
- untreated thyroid disease
- life-threatening illness with a prognosis of <5 years;
- history of deep vein thrombosis,
- pulmonary embolism, or breast cancer;
- currently receiving estrogen therapy.
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
Recruit postmenopausal women and randomly assign them to one of four groups: Early Postmenopausal Exercise Group (EE), Late Postmenopausal Exercise Group (LE), Early Postmenopausal Control Group (EC), and Late Postmenopausal Control Group (LC).
All participates will undergo a graded exercise test to determine their maximum oxygen uptake, and vascular function response will be measured immediately after the exercise test. The COP exercise intensity for postmenopausal women will be obtained through the exercise test, and subjects in the EE and LE groups will undergo exercise training at this intensity for a period of three months. Tests and analyses of relevant indicators will be conducted on subjects in all four groups before and after the intervention. The exercise load experiments will be performed on a cycle ergometer.
- Conditions
- Vascular Health
- Being tested
- COP exercise
- Keywords
- vascular health, crossover point
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COP exerciseOther
crossover point intensity exercise
| Study group | Role | What they receive |
|---|---|---|
| Early Postmenopausal Exercise Group (EE) | Experimental | Not described Receives: Other: COP exercise |
| Late Postmenopausal Exercise Group (LE) | Experimental | Not described Receives: Other: COP exercise |
| Early Postmenopausal Control Group (EC) | No intervention | Not described |
| Late Postmenopausal Control Group (LC) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial Artery Flow-Mediated Dilation
The changes in brachial artery flow-mediated dilation are assessed at three time points: before the intervention, after the acute exercise, and three months following the intervention.
Measured: 12 weeks
Carotid Intima-Media Thickness
The change of Carotid Intima-Media Thickness before and after intervention.
Measured: 12 weeks
Carotid Diameter
The change of Carotid Diameter before and after intervention.
Measured: 12 weeks
Carotid End-Diastolic Velocity
The change of Carotid End-Diastolic Velocity before and after intervention.
Measured: 12 weeks
Carotid Peak Systolic Velocity
The change of Carotid Peak Systolic Velocity before and after intervention.
Measured: 12 weeks
Pulsatility Index
The change of Pulsatility Index before and after intervention.
Measured: 12 weeks
Resistive Index
The change of Resistive Index before and after intervention
Measured: 12 weeks
Brachial-Ankle Pulse Wave Velocity
The change of Brachial-Ankle Pulse Wave Velocity before and after intervention.
Measured: 12 weeks
Ankle-Brachial Index
The change of Ankle-Brachial Index before and after intervention.
Measured: 12 weeks
Secondary outcomes (43)
Serum Nitric Oxide level
The change of serum nitric oxide before and after intervention.
Measured: 12 weeks
Plasma Nitrate level
The change of plasma nitrate before and after intervention.
Measured: 12 weeks
ERRα mRNA and Protein Expression level
The change of ERRα mRNA and Protein Expression before and after intervention.
Measured: 12 weeks
PGC1α mRNA Expression level
The change of PGC1α mRNA Expression before and after intervention
Measured: 12 weeks
PGC1α Protein Expression level
The change of PGC1α Protein Expression before and after intervention
Measured: 12 weeks
ERα mRNA Expression level
The change of ERα mRNA Expression before and after intervention
Measured: 12 weeks
ERα Protein Expression level
The change of Protein Expression before and after intervention
Measured: 12 weeks
p38MAPK mRNA Expression level
The change of p38MAPK mRNA Expression before and after intervention
Measured: 12 weeks
p38MAPK Protein Expression level
The change of p38MAPK Protein Expression before and after intervention
Measured: 12 weeks
Serum Reduced Glutathione level
The change of Serum Reduced Glutathione before and after intervention
Measured: 12 weeks
Oxidized Glutathione level
The change of Oxidized Glutathione before and after intervention
Measured: 12 weeks
Calculate GSSG/GSH Ratio
The change of Calculate GSSG/GSH Ratio before and after intervention
Measured: 12 weeks
Serum Soluble Vascular Cell Adhesion Molecule-1 level
The change of Serum Soluble Vascular Cell Adhesion Molecule-1 Expression before and after intervention
Measured: 12 weeks
Soluble Intercellular Adhesion Molecule-1 level
The change of Soluble Intercellular Adhesion Molecule-1 before and after intervention
Measured: 12 weeks
Vascular Endothelial Growth Factor level
The change of Vascular Endothelial Growth Factor before and after intervention
Measured: 12 weeks
body weight
The change of body weight before and after intervention
Measured: 12 weeks
body mass index
The change of body mass index before and after intervention
Measured: 12 weeks
Total Cholesterol level
The change of Total Cholesterol before and after intervention
Measured: 12 weeks
Triglycerides level
The change of Triglycerides before and after intervention
Measured: 12 weeks
High-Density Lipoprotein Cholesterol level
The change of High-Density Lipoprotein Cholesterol before and after intervention
Measured: 12 weeks
Low-Density Lipoprotein Cholesterol level
The change of Low-Density Lipoprotein Cholesterol before and after intervention
Measured: 12 weeks
Apolipoprotein AI level
The change of Apolipoprotein AI before and after intervention
Measured: 12 weeks
Apolipoprotein B level
The change of Apolipoprotein B before and after intervention
Measured: 12 weeks
Lipoprotein(a) level
The change of Lipoprotein(a) before and after intervention
Measured: 12 weeks
Interleukin 6 level
The change of Interleukin 6 before and after intervention
Measured: 12 weeks
Estradiol level
The change of Estradiol before and after intervention
Measured: 12 weeks
Interventricular Septum Thickness in Systole
The change of Interventricular Septum Thickness in Systole before and after intervention
Measured: 12 weeks
Interventricular Septum Thickness in Diastole
The change of Interventricular Septum Thickness in Diastole before and after intervention
Measured: 12 weeks
Left Ventricular End-Systolic Diameter
The change of Left Ventricular End-Systolic Diameter before and after intervention
Measured: 12 weeks
Left Ventricular End-Diastolic Diameter
The change of Left Ventricular End-Diastolic Diameter before and after intervention
Measured: 12 weeks
Left Ventricular Posterior Wall Thickness in Systole
The change of Left Ventricular Posterior Wall Thickness in Systole before and after intervention
Measured: 12 weeks
Left Ventricular Posterior Wall Thickness in Diastole
The change of Left Ventricular Posterior Wall Thickness in Diastole before and after intervention
Measured: 12 weeks
Left Ventricular End-Systolic Volume
The change of Left Ventricular End-Systolic Volume before and after intervention
Measured: 12 weeks
Left Ventricular End-Diastolic Volume
The change of Left Ventricular End-Diastolic Volume before and after intervention
Measured: 12 weeks
Fractional Shortening
The change of Fractional Shortening before and after intervention
Measured: 12 weeks
Left Ventricular Ejection Fraction
The change of Left Ventricular Ejection Fraction before and after intervention
Measured: 12 weeks
Stroke Volume
The change of Stroke Volume before and after intervention
Measured: 12 weeks
Heart Rate
The change of Heart Rate before and after intervention
Measured: 12 weeks
Early Diastolic Mitral Inflow Velocity
The change of Early Diastolic Mitral Inflow Velocity before and after intervention
Measured: 12 weeks
Atrial Diastolic Mitral Inflow Velocity
The change of Atrial Diastolic Mitral Inflow Velocity before and after intervention
Measured: 12 weeks
Ratio of Early to Atrial Diastolic Mitral Inflow Velocity
The change of Ratio of Early to Atrial Diastolic Mitral Inflow Velocity before and after intervention
Measured: 12 weeks
Cardiac Output
The change of Cardiac Output before and after intervention
Measured: 12 weeks
NT-proBNP level
The change of NT-proBNP 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 posted11 Jan 2024
- Study start11 Dec 2023
- Primary completion30 Sep 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 Vascular HealthStudies 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
- 120 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
- NCT06201312
- Sponsor's protocol ID
- EOCPEOVFOWIDMY
- Status last verified
- Dec 2023
- First submitted
- 7 Dec 2023
- Last updated
- 11 Jan 2024
- 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 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Crossover Point Exercise on Vascular Function of Women in Different Menopausal Years
- ClinicalTrials.gov ID
- NCT06201312
- Acronym / sponsor ID
- EOCPEOVFOWIDMY
- Conditions
- Vascular Health
- Keywords
- vascular health, crossover point
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Beijing Sport UniversityUniversity, hospital or other
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 11 Jan 2024 (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.
Recruit postmenopausal women and randomly assign them to one of four groups: Early Postmenopausal Exercise Group (EE), Late Postmenopausal Exercise Group (LE), Early Postmenopausal Control Group (EC), and Late Postmenopausal Control Group (LC).
All participates will undergo a graded exercise test to determine their maximum oxygen uptake, and vascular function response will be measured immediately after the exercise test. The COP exercise intensity for postmenopausal women will be obtained through the exercise test, and subjects in the EE and LE groups will undergo exercise training at this intensity for a period of three months. Tests and analyses of relevant indicators will be conducted on subjects in all four groups before and after the intervention. The exercise load experiments will be performed on a cycle ergometer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Early Postmenopausal Exercise Group (EE) | Experimental | Other: COP exercise |
| Late Postmenopausal Exercise Group (LE) | Experimental | Other: COP exercise |
| Early Postmenopausal Control Group (EC) | No intervention | – |
| Late Postmenopausal Control Group (LC) | No intervention | – |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Postmenopausal women without cardiovascular disease
Key exclusion criteria (11 listed)
- Women with undetermined menopause
- BMI <18.5 kg/m2 or BMI >28 kg/m2
- fasting plasma triglyceride levels ≥500 mgdl
- diabetes mellitus or fasting glucose >140 mgd
- blood creatinine >2.0 mgdl
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 |
|---|---|---|
| COP exercisecrossover point intensity exercise | Other | Early Postmenopausal Exercise Group (EE), Late Postmenopausal Exercise Group (LE) |
Primary outcome
Brachial Artery Flow-Mediated Dilation
Time frame: 12 weeks
The changes in brachial artery flow-mediated dilation are assessed at three time points: before the intervention, after the acute exercise, and three months following the intervention.
Carotid Intima-Media Thickness
Time frame: 12 weeks
The change of Carotid Intima-Media Thickness before and after intervention.
Carotid Diameter
Time frame: 12 weeks
The change of Carotid Diameter before and after intervention.
Carotid End-Diastolic Velocity
Time frame: 12 weeks
The change of Carotid End-Diastolic Velocity before and after intervention.
Carotid Peak Systolic Velocity
Time frame: 12 weeks
The change of Carotid Peak Systolic Velocity before and after intervention.
Pulsatility Index
Time frame: 12 weeks
The change of Pulsatility Index before and after intervention.
Resistive Index
Time frame: 12 weeks
The change of Resistive Index before and after intervention
Brachial-Ankle Pulse Wave Velocity
Time frame: 12 weeks
The change of Brachial-Ankle Pulse Wave Velocity before and after intervention.
Ankle-Brachial Index
Time frame: 12 weeks
The change of Ankle-Brachial Index before and after intervention.
43 secondary outcomes
Serum Nitric Oxide level
Time frame: 12 weeks
Plasma Nitrate level
Time frame: 12 weeks
ERRα mRNA and Protein Expression level
Time frame: 12 weeks
PGC1α mRNA Expression level
Time frame: 12 weeks
PGC1α Protein Expression level
Time frame: 12 weeks
ERα mRNA Expression level
Time frame: 12 weeks
ERα Protein Expression level
Time frame: 12 weeks
p38MAPK mRNA Expression level
Time frame: 12 weeks
p38MAPK Protein Expression level
Time frame: 12 weeks
Serum Reduced Glutathione level
Time frame: 12 weeks
Oxidized Glutathione level
Time frame: 12 weeks
Calculate GSSG/GSH Ratio
Time frame: 12 weeks
Serum Soluble Vascular Cell Adhesion Molecule-1 level
Time frame: 12 weeks
Soluble Intercellular Adhesion Molecule-1 level
Time frame: 12 weeks
Vascular Endothelial Growth Factor level
Time frame: 12 weeks
body weight
Time frame: 12 weeks
body mass index
Time frame: 12 weeks
Total Cholesterol level
Time frame: 12 weeks
Triglycerides level
Time frame: 12 weeks
High-Density Lipoprotein Cholesterol level
Time frame: 12 weeks
Low-Density Lipoprotein Cholesterol level
Time frame: 12 weeks
Apolipoprotein AI level
Time frame: 12 weeks
Apolipoprotein B level
Time frame: 12 weeks
Lipoprotein(a) level
Time frame: 12 weeks
Interleukin 6 level
Time frame: 12 weeks
Estradiol level
Time frame: 12 weeks
Interventricular Septum Thickness in Systole
Time frame: 12 weeks
Interventricular Septum Thickness in Diastole
Time frame: 12 weeks
Left Ventricular End-Systolic Diameter
Time frame: 12 weeks
Left Ventricular End-Diastolic Diameter
Time frame: 12 weeks
Left Ventricular Posterior Wall Thickness in Systole
Time frame: 12 weeks
Left Ventricular Posterior Wall Thickness in Diastole
Time frame: 12 weeks
Left Ventricular End-Systolic Volume
Time frame: 12 weeks
Left Ventricular End-Diastolic Volume
Time frame: 12 weeks
Fractional Shortening
Time frame: 12 weeks
Left Ventricular Ejection Fraction
Time frame: 12 weeks
Stroke Volume
Time frame: 12 weeks
Heart Rate
Time frame: 12 weeks
Early Diastolic Mitral Inflow Velocity
Time frame: 12 weeks
Atrial Diastolic Mitral Inflow Velocity
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 11 Jan 2024.
Related trials for Vascular Health
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Use and Acceptability of an AI-Assisted Health Application for Individuals Living With a Chronic Condition
Hypertension, Diabetes Mellitus, Type 2
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
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 COP exercise in people with Vascular Health, 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 1 inclusion and 11 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 11 Jan 2024. 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. 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?
Brachial Artery Flow-Mediated Dilation (time frame: 12 weeks). The study lists 9 primary outcomes in all. 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 11 Jan 2024.