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

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 Overview

• Status: Recruiting
• Conditions: Vascular Health
• Intervention / Treatment: Other: COP exercise

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peizhen Zhang; Phone Number: 01062989581; Email: zhpzh@bsu.edu.cn

Study Locations

• China
  • Beijing, China
    • Recruiting
    • School of Sports Medicine and Rehabilitation, Beijing Sport University
    • Contact: Peizhen Zhang; Email: zhpzh@bsu.edu.cn
    • Principal Investigator: Peizhen Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Postmenopausal Exercise Group (EE)	Other: COP exercise; crossover point intensity exercise
Experimental: Late Postmenopausal Exercise Group (LE)	Other: COP exercise; crossover point intensity exercise
No Intervention: Early Postmenopausal Control Group (EC)
No Intervention: Late Postmenopausal Control Group (LC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Carotid Intima-Media Thickness	The change of Carotid Intima-Media Thickness before and after intervention.	12 weeks
Carotid Diameter	The change of Carotid Diameter before and after intervention.	12 weeks
Carotid End-Diastolic Velocity	The change of Carotid End-Diastolic Velocity before and after intervention.	12 weeks
Carotid Peak Systolic Velocity	The change of Carotid Peak Systolic Velocity before and after intervention.	12 weeks
Pulsatility Index	The change of Pulsatility Index before and after intervention.	12 weeks
Resistive Index	The change of Resistive Index before and after intervention	12 weeks
Brachial-Ankle Pulse Wave Velocity	The change of Brachial-Ankle Pulse Wave Velocity before and after intervention.	12 weeks
Ankle-Brachial Index	The change of Ankle-Brachial Index before and after intervention.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Nitric Oxide level	The change of serum nitric oxide before and after intervention.	12 weeks
Plasma Nitrate level	The change of plasma nitrate before and after intervention.	12 weeks
ERRα mRNA and Protein Expression level	The change of ERRα mRNA and Protein Expression before and after intervention.	12 weeks
PGC1α mRNA Expression level	The change of PGC1α mRNA Expression before and after intervention	12 weeks
PGC1α Protein Expression level	The change of PGC1α Protein Expression before and after intervention	12 weeks
ERα mRNA Expression level	The change of ERα mRNA Expression before and after intervention	12 weeks
ERα Protein Expression level	The change of Protein Expression before and after intervention	12 weeks
p38MAPK mRNA Expression level	The change of p38MAPK mRNA Expression before and after intervention	12 weeks
p38MAPK Protein Expression level	The change of p38MAPK Protein Expression before and after intervention	12 weeks
Serum Reduced Glutathione level	The change of Serum Reduced Glutathione before and after intervention	12 weeks
Oxidized Glutathione level	The change of Oxidized Glutathione before and after intervention	12 weeks
Calculate GSSG/GSH Ratio	The change of Calculate GSSG/GSH Ratio before and after intervention	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	12 weeks
Soluble Intercellular Adhesion Molecule-1 level	The change of Soluble Intercellular Adhesion Molecule-1 before and after intervention	12 weeks
Vascular Endothelial Growth Factor level	The change of Vascular Endothelial Growth Factor before and after intervention	12 weeks
body weight	The change of body weight before and after intervention	12 weeks
body mass index	The change of body mass index before and after intervention	12 weeks
Total Cholesterol level	The change of Total Cholesterol before and after intervention	12 weeks
Triglycerides level	The change of Triglycerides before and after intervention	12 weeks
High-Density Lipoprotein Cholesterol level	The change of High-Density Lipoprotein Cholesterol before and after intervention	12 weeks
Low-Density Lipoprotein Cholesterol level	The change of Low-Density Lipoprotein Cholesterol before and after intervention	12 weeks
Apolipoprotein AI level	The change of Apolipoprotein AI before and after intervention	12 weeks
Apolipoprotein B level	The change of Apolipoprotein B before and after intervention	12 weeks
Lipoprotein(a) level	The change of Lipoprotein(a) before and after intervention	12 weeks
Interleukin 6 level	The change of Interleukin 6 before and after intervention	12 weeks
Estradiol level	The change of Estradiol before and after intervention	12 weeks
Interventricular Septum Thickness in Systole	The change of Interventricular Septum Thickness in Systole before and after intervention	12 weeks
Interventricular Septum Thickness in Diastole	The change of Interventricular Septum Thickness in Diastole before and after intervention	12 weeks
Left Ventricular End-Systolic Diameter	The change of Left Ventricular End-Systolic Diameter before and after intervention	12 weeks
Left Ventricular End-Diastolic Diameter	The change of Left Ventricular End-Diastolic Diameter before and after intervention	12 weeks
Left Ventricular Posterior Wall Thickness in Systole	The change of Left Ventricular Posterior Wall Thickness in Systole before and after intervention	12 weeks
Left Ventricular Posterior Wall Thickness in Diastole	The change of Left Ventricular Posterior Wall Thickness in Diastole before and after intervention	12 weeks
Left Ventricular End-Systolic Volume	The change of Left Ventricular End-Systolic Volume before and after intervention	12 weeks
Left Ventricular End-Diastolic Volume	The change of Left Ventricular End-Diastolic Volume before and after intervention	12 weeks
Fractional Shortening	The change of Fractional Shortening before and after intervention	12 weeks
Left Ventricular Ejection Fraction	The change of Left Ventricular Ejection Fraction before and after intervention	12 weeks
Stroke Volume	The change of Stroke Volume before and after intervention	12 weeks
Heart Rate	The change of Heart Rate before and after intervention	12 weeks
Early Diastolic Mitral Inflow Velocity	The change of Early Diastolic Mitral Inflow Velocity before and after intervention	12 weeks
Atrial Diastolic Mitral Inflow Velocity	The change of Atrial Diastolic Mitral Inflow Velocity before and after intervention	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	12 weeks
Cardiac Output	The change of Cardiac Output before and after intervention	12 weeks
NT-proBNP level	The change of NT-proBNP before and after intervention	12 weeks

Collaborators and Investigators

• Sponsor: Beijing Sport University

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2023
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Actual): January 11, 2024

Study Record Updates

• Last Update Posted (Actual): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: vascular health; crossover point
• Other Study ID Numbers: EOCPEOVFOWIDMY

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No