Effects of Crossover Point Exercise on Vascular Function of Women in Different Menopausal Years

Vascular Health Clinical Trial

Official title:

Effects of Crossover Point Exercise on Vascular Function of Women in Different Menopausal Years

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06201312
• Other study ID #: EOCPEOVFOWIDMY
• Status: Recruiting
• Phase: N/A
• Start date: December 11, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: Beijing Sport University
• Contact: Peizhen Zhang
• Phone: 01062989581
• Email: zhpzh[@]bsu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 70 Years

Eligibility

Inclusion Criteria:

• Postmenopausal women without cardiovascular disease

Exclusion Criteria:

• 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)

• 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.

Related Conditions & MeSH terms

• Vascular Health

Intervention

Other:
• COP exercise
crossover point intensity exercise

Locations

Country	Name	City	State
China	School of Sports Medicine and Rehabilitation, Beijing Sport University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Sport University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks
Primary	Carotid Intima-Media Thickness	The change of Carotid Intima-Media Thickness before and after intervention.	12 weeks
Primary	Carotid Diameter	The change of Carotid Diameter before and after intervention.	12 weeks
Primary	Carotid End-Diastolic Velocity	The change of Carotid End-Diastolic Velocity before and after intervention.	12 weeks
Primary	Carotid Peak Systolic Velocity	The change of Carotid Peak Systolic Velocity before and after intervention.	12 weeks
Primary	Pulsatility Index	The change of Pulsatility Index before and after intervention.	12 weeks
Primary	Resistive Index	The change of Resistive Index before and after intervention	12 weeks
Primary	Brachial-Ankle Pulse Wave Velocity	The change of Brachial-Ankle Pulse Wave Velocity before and after intervention.	12 weeks
Primary	Ankle-Brachial Index	The change of Ankle-Brachial Index before and after intervention.	12 weeks
Secondary	Serum Nitric Oxide level	The change of serum nitric oxide before and after intervention.	12 weeks
Secondary	Plasma Nitrate level	The change of plasma nitrate before and after intervention.	12 weeks
Secondary	ERRa mRNA and Protein Expression level	The change of ERRa mRNA and Protein Expression before and after intervention.	12 weeks
Secondary	PGC1a mRNA Expression level	The change of PGC1a mRNA Expression before and after intervention	12 weeks
Secondary	PGC1a Protein Expression level	The change of PGC1a Protein Expression before and after intervention	12 weeks
Secondary	ERa mRNA Expression level	The change of ERa mRNA Expression before and after intervention	12 weeks
Secondary	ERa Protein Expression level	The change of Protein Expression before and after intervention	12 weeks
Secondary	p38MAPK mRNA Expression level	The change of p38MAPK mRNA Expression before and after intervention	12 weeks
Secondary	p38MAPK Protein Expression level	The change of p38MAPK Protein Expression before and after intervention	12 weeks
Secondary	Serum Reduced Glutathione level	The change of Serum Reduced Glutathione before and after intervention	12 weeks
Secondary	Oxidized Glutathione level	The change of Oxidized Glutathione before and after intervention	12 weeks
Secondary	Calculate GSSG/GSH Ratio	The change of Calculate GSSG/GSH Ratio before and after intervention	12 weeks
Secondary	Serum Soluble Vascular Cell Adhesion Molecule-1 level	The change of Serum Soluble Vascular Cell Adhesion Molecule-1 Expression before and after intervention	12 weeks
Secondary	Soluble Intercellular Adhesion Molecule-1 level	The change of Soluble Intercellular Adhesion Molecule-1 before and after intervention	12 weeks
Secondary	Vascular Endothelial Growth Factor level	The change of Vascular Endothelial Growth Factor before and after intervention	12 weeks
Secondary	body weight	The change of body weight before and after intervention	12 weeks
Secondary	body mass index	The change of body mass index before and after intervention	12 weeks
Secondary	Total Cholesterol level	The change of Total Cholesterol before and after intervention	12 weeks
Secondary	Triglycerides level	The change of Triglycerides before and after intervention	12 weeks
Secondary	High-Density Lipoprotein Cholesterol level	The change of High-Density Lipoprotein Cholesterol before and after intervention	12 weeks
Secondary	Low-Density Lipoprotein Cholesterol level	The change of Low-Density Lipoprotein Cholesterol before and after intervention	12 weeks
Secondary	Apolipoprotein AI level	The change of Apolipoprotein AI before and after intervention	12 weeks
Secondary	Apolipoprotein B level	The change of Apolipoprotein B before and after intervention	12 weeks
Secondary	Lipoprotein(a) level	The change of Lipoprotein(a) before and after intervention	12 weeks
Secondary	Interleukin 6 level	The change of Interleukin 6 before and after intervention	12 weeks
Secondary	Estradiol level	The change of Estradiol before and after intervention	12 weeks
Secondary	Interventricular Septum Thickness in Systole	The change of Interventricular Septum Thickness in Systole before and after intervention	12 weeks
Secondary	Interventricular Septum Thickness in Diastole	The change of Interventricular Septum Thickness in Diastole before and after intervention	12 weeks
Secondary	Left Ventricular End-Systolic Diameter	The change of Left Ventricular End-Systolic Diameter before and after intervention	12 weeks
Secondary	Left Ventricular End-Diastolic Diameter	The change of Left Ventricular End-Diastolic Diameter before and after intervention	12 weeks
Secondary	Left Ventricular Posterior Wall Thickness in Systole	The change of Left Ventricular Posterior Wall Thickness in Systole before and after intervention	12 weeks
Secondary	Left Ventricular Posterior Wall Thickness in Diastole	The change of Left Ventricular Posterior Wall Thickness in Diastole before and after intervention	12 weeks
Secondary	Left Ventricular End-Systolic Volume	The change of Left Ventricular End-Systolic Volume before and after intervention	12 weeks
Secondary	Left Ventricular End-Diastolic Volume	The change of Left Ventricular End-Diastolic Volume before and after intervention	12 weeks
Secondary	Fractional Shortening	The change of Fractional Shortening before and after intervention	12 weeks
Secondary	Left Ventricular Ejection Fraction	The change of Left Ventricular Ejection Fraction before and after intervention	12 weeks
Secondary	Stroke Volume	The change of Stroke Volume before and after intervention	12 weeks
Secondary	Heart Rate	The change of Heart Rate before and after intervention	12 weeks
Secondary	Early Diastolic Mitral Inflow Velocity	The change of Early Diastolic Mitral Inflow Velocity before and after intervention	12 weeks
Secondary	Atrial Diastolic Mitral Inflow Velocity	The change of Atrial Diastolic Mitral Inflow Velocity before and after intervention	12 weeks
Secondary	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	12 weeks
Secondary	Cardiac Output	The change of Cardiac Output before and after intervention	12 weeks
Secondary	NT-proBNP level	The change of NT-proBNP before and after intervention	12 weeks