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Clinical Trials/NCT06201312
NCT06201312
Recruiting
Not Applicable

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

Beijing Sport University1 site in 1 country120 target enrollmentDecember 11, 2023
ConditionsVascular Health

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vascular Health
Sponsor
Beijing Sport University
Enrollment
120
Locations
1
Primary Endpoint
Brachial-Ankle Pulse Wave Velocity
Status
Recruiting
Last Updated
2 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
December 11, 2023
End Date
December 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Beijing Sport University
Responsible Party
Sponsor

Eligibility Criteria

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;

Outcomes

Primary Outcomes

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.

Carotid Intima-Media Thickness

Time Frame: 12 weeks

The change of Carotid Intima-Media Thickness before and after intervention.

Resistive Index

Time Frame: 12 weeks

The change of Resistive Index before and after intervention

Carotid Diameter

Time Frame: 12 weeks

The change of Carotid Diameter before and after intervention.

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 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.

Secondary Outcomes

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

Study Sites (1)

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