Clinical trial NCT06201312: Effects of Crossover Point Exercise on Vascular Function of Women in Different Menopausal Years
Official title: Effects of Crossover Point Exercise on Vascular Function of Women in Different Menopausal Years
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vascular Health
Keywords: vascular health
crossover point
Lead sponsor: Beijing Sport University
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 120
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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;
* currently receiving estrogen therapy.

Primary outcomes:
measure: Brachial Artery Flow-Mediated Dilation
timeFrame: 12 weeks
measure: Carotid Intima-Media Thickness
timeFrame: 12 weeks
measure: Carotid Diameter
timeFrame: 12 weeks
measure: Carotid End-Diastolic Velocity
timeFrame: 12 weeks
measure: Carotid Peak Systolic Velocity
timeFrame: 12 weeks
measure: Pulsatility Index
timeFrame: 12 weeks
measure: Resistive Index
timeFrame: 12 weeks
measure: Brachial-Ankle Pulse Wave Velocity
timeFrame: 12 weeks
measure: Ankle-Brachial Index
timeFrame: 12 weeks
Secondary outcomes:
measure: Serum Nitric Oxide level
timeFrame: 12 weeks
measure: Plasma Nitrate level
timeFrame: 12 weeks
measure: ERRα mRNA and Protein Expression level
timeFrame: 12 weeks
measure: PGC1α mRNA Expression level
timeFrame: 12 weeks
measure: PGC1α Protein Expression level
timeFrame: 12 weeks
measure: ERα mRNA Expression level
timeFrame: 12 weeks
measure: ERα Protein Expression level
timeFrame: 12 weeks
measure: p38MAPK mRNA Expression level
timeFrame: 12 weeks
measure: p38MAPK Protein Expression level
timeFrame: 12 weeks
measure: Serum Reduced Glutathione level
timeFrame: 12 weeks
measure: Oxidized Glutathione level
timeFrame: 12 weeks
measure: Calculate GSSG/GSH Ratio
timeFrame: 12 weeks
measure: Serum Soluble Vascular Cell Adhesion Molecule-1 level
timeFrame: 12 weeks
measure: Soluble Intercellular Adhesion Molecule-1 level
timeFrame: 12 weeks
measure: Vascular Endothelial Growth Factor level
timeFrame: 12 weeks
measure: body weight
timeFrame: 12 weeks
measure: body mass index
timeFrame: 12 weeks
measure: Total Cholesterol level
timeFrame: 12 weeks
measure: Triglycerides level
timeFrame: 12 weeks
measure: High-Density Lipoprotein Cholesterol level
timeFrame: 12 weeks
measure: Low-Density Lipoprotein Cholesterol level
timeFrame: 12 weeks
measure: Apolipoprotein AI level
timeFrame: 12 weeks
measure: Apolipoprotein B level
timeFrame: 12 weeks
measure: Lipoprotein(a) level
timeFrame: 12 weeks
measure: Interleukin 6 level
timeFrame: 12 weeks
measure: Estradiol level
timeFrame: 12 weeks
measure: Interventricular Septum Thickness in Systole
timeFrame: 12 weeks
measure: Interventricular Septum Thickness in Diastole
timeFrame: 12 weeks
measure: Left Ventricular End-Systolic Diameter
timeFrame: 12 weeks
measure: Left Ventricular End-Diastolic Diameter
timeFrame: 12 weeks
measure: Left Ventricular Posterior Wall Thickness in Systole
timeFrame: 12 weeks
measure: Left Ventricular Posterior Wall Thickness in Diastole
timeFrame: 12 weeks
measure: Left Ventricular End-Systolic Volume
timeFrame: 12 weeks
measure: Left Ventricular End-Diastolic Volume
timeFrame: 12 weeks
measure: Fractional Shortening
timeFrame: 12 weeks
measure: Left Ventricular Ejection Fraction
timeFrame: 12 weeks
measure: Stroke Volume
timeFrame: 12 weeks
measure: Heart Rate
timeFrame: 12 weeks
measure: Early Diastolic Mitral Inflow Velocity
timeFrame: 12 weeks
measure: Atrial Diastolic Mitral Inflow Velocity
timeFrame: 12 weeks
measure: Ratio of Early to Atrial Diastolic Mitral Inflow Velocity
timeFrame: 12 weeks
measure: Cardiac Output
timeFrame: 12 weeks
measure: NT-proBNP level
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: School of Sports Medicine and Rehabilitation, Beijing Sport University
Study officials:
References: