Effects of CE on the Risk of Arteriosclerosis in SED Postmenopausal Women
Effects of Combined Exercise on the Risk of Arteriosclerosis in Sedentary Postmenopausal Women
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Beijing, China
- School of Sports Medicine and Rehabilitation, Beijing Sport University
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants have been postmenopausal for more than 12 months and have not received any exogenous estrogen supplementation after menopause.
- Participants were screened using the International Physical Activity Questionnaire-Short Form (IPAQ-S), with a physical activity level classified as "low." They must not have engaged in moderate-intensity physical activity for at least 3 days per week, with a duration of no less than 30 minutes per day, for over 3 consecutive months.
- Participants were screened using the Physical Activity Readiness Questionnaire+ (PAR-Q+) and be deemed safe to undergo further intervention.
Exclusion Criteria:
- Participants with acute or chronic musculoskeletal disorders, cardiovascular diseases, or similar conditions.
- Participants with abnormal blood pressure: resting systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg, or those taking antihypertensive medications.
- Participants with abnormally high arterial stiffness (within pathological range): brachial-ankle pulse wave velocity (baPWV) >1800 cm/s.
- Participants recently taken medications that may affect blood indicators, such as hormones or anti-inflammatory drugs.
- Participants with unstable body weight in the past 3 months (fluctuation greater than ±2.5 kg).
- Participants currently participating in other intervention studies or those with regular exercise habits in daily life.
- Participants who smoke or consume alcohol regularly.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: AE group
|
Aerobic exercise
|
|
Active Comparator: RE group
|
Resistance exercise
|
|
Active Comparator: CE group
|
Combined exercise
|
|
Active Comparator: CON group
|
No intervention
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Flow mediated dilation (FMD)
Time Frame: 12 weeks
|
The change of flow mediated dilation before and after intervention.
|
12 weeks
|
|
Brachial ankle pulse wave velocity (baPWV)
Time Frame: 12 weeks
|
The change of baPWV before and after intervention.
|
12 weeks
|
|
Ankle brachial index (ABI)
Time Frame: 12 weeks
|
The change of ABI before and after intervention.
|
12 weeks
|
|
Carotid intima-media thickness (cIMT)
Time Frame: 12 weeks
|
The change of cIMT before and after intervention.
|
12 weeks
|
|
Systolic blood pressure (SBP)
Time Frame: 12 weeks
|
The change of SBP before and after intervention.
|
12 weeks
|
|
Diastolic blood pressure (DBP)
Time Frame: 12 weeks
|
The change of DBP before and after intervention.
|
12 weeks
|
|
Peak systolic velocity (PSV)
Time Frame: 12 weeks
|
The change of PSV of carotid artery before and after intervention.
|
12 weeks
|
|
End diastolic velocity (EDV)
Time Frame: 12 weeks
|
The change of EDV of carotid artery before and after intervention.
|
12 weeks
|
|
Pulsatility index (PI)
Time Frame: 12 weeks
|
The change of PI of carotid artery before and after intervention.
|
12 weeks
|
|
Resistance index (RI)
Time Frame: 12 weeks
|
The change of RI of carotid artery before and after intervention.
|
12 weeks
|
|
Wall Shear Stress (WSS)
Time Frame: 12 weeks
|
The change of WSS of carotid artery before and after intervention.
|
12 weeks
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nitric oxide (NO)
Time Frame: 12 weeks
|
The change of serum NO before and after intervention.
|
12 weeks
|
|
Prostacyclin (PGI2)
Time Frame: 12 weeks
|
The change of serum PGI2 before and after intervention.
|
12 weeks
|
|
Endothelin-1 (ET-1)
Time Frame: 12 weeks
|
The change of serum ET-1 before and after intervention.
|
12 weeks
|
|
Angiotensin II (AngII)
Time Frame: 12 weeks
|
The change of serum AngII before and after intervention.
|
12 weeks
|
|
C-Reactive protein (CRP)
Time Frame: 12 weeks
|
The change of serum CRP before and after intervention.
|
12 weeks
|
|
Interleukin-6 (IL-6)
Time Frame: 12 weeks
|
The change of serum IL-6 before and after intervention.
|
12 weeks
|
|
Estrogen
Time Frame: 12 weeks
|
The change of serum estrogen before and after intervention.
|
12 weeks
|
|
Soluble intercellular adhesion molecule-1(sICAM-1)
Time Frame: 12 weeks
|
The change of serum sICAM-1 before and after intervention.
|
12 weeks
|
|
Soluble vascular cell adhesion molecule-1 (sVCAM-1)
Time Frame: 12 weeks
|
The change of serum sVCAM-1 before and after intervention.
|
12 weeks
|
|
Total Cholesterol (TC)
Time Frame: 12 weeks
|
The change of serum TC before and after intervention.
|
12 weeks
|
|
High-density lipoprotein cholesterol (HDL-C)
Time Frame: 12 weeks
|
The change of serum HDL-C before and after intervention.
|
12 weeks
|
|
Low-density lipoprotein cholesterol (LDL-C)
Time Frame: 12 weeks
|
The change of serum LDL-C before and after intervention.
|
12 weeks
|
|
Left ventricular posterior wall thickness at end-diastole (LVPWd)
Time Frame: 12 weeks
|
The change of LVPWd before and after intervention.
|
12 weeks
|
|
Left ventricular posterior wall thickness at end-systole (LVPWs)
Time Frame: 12 weeks
|
The change of LVPWs before and after intervention.
|
12 weeks
|
|
Stroke volume (SV)
Time Frame: 12 weeks
|
The change of SV before and after intervention.
|
12 weeks
|
|
Heart rate (HR)
Time Frame: 12 weeks
|
The change of HR before and after intervention.
|
12 weeks
|
|
Left ventricular ejection fraction (LVEF)
Time Frame: 12 weeks
|
The change of LVEF before and after intervention.
|
12 weeks
|
|
Cardiac output (CO)
Time Frame: 12 weeks
|
The change of CO before and after intervention.
|
12 weeks
|
|
Endothelial Nitric Oxide Synthase (eNOS)
Time Frame: 12 weeks
|
The change of serum eNOS before and after intervention.
|
12 weeks
|
|
Maximal oxygen uptake (VO2max)
Time Frame: 12 weeks
|
The change of VO2max before and after intervention.
|
12 weeks
|
|
Body mass index (BMI)
Time Frame: 12 weeks
|
The change of BMI before and after intervention.
|
12 weeks
|
|
Body fat weight
Time Frame: 12 weeks
|
The change of body fat weight before and after intervention.
|
12 weeks
|
|
Body fat%
Time Frame: 12 weeks
|
The change of body fat% before and after intervention.
|
12 weeks
|
|
Pittsburgh sleep quality index (PSQI)
Time Frame: 12 weeks
|
The change of PSQI before and after intervention.
|
12 weeks
|
|
Food frequency questionnaire (FFQ)
Time Frame: 12 weeks
|
The change of FFQ before and after intervention.
|
12 weeks
|
|
Cluster of Differentiation 14 (CD14) mRNA and Protein Expression
Time Frame: 12 weeks
|
The change of CD14 mRNA and Protein Expression before and after intervention.
|
12 weeks
|
|
Mitogen-activated protein kinase 14 (MAPK14) mRNA
Time Frame: 12 weeks
|
The change of MAPK14 mRNA before and after intervention.
|
12 weeks
|
|
p38 Mitogen-activated protein kinase (p38 MAPK) Protein Expression
Time Frame: 12 weeks
|
The change of p38 MAPK Protein Expression before and after intervention.
|
12 weeks
|
|
Tetraspanin 4 (TSPAN4) mRNA and Protein Expression
Time Frame: 12 weeks
|
The change of TSPAN4 mRNA and Protein Expression before and after intervention.
|
12 weeks
|
|
Nitric Oxide Synthase 3 (NOS3) mRNA and Protein Expression
Time Frame: 12 weeks
|
The change of NOS3 mRNA and Protein Expression before and after intervention.
|
12 weeks
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- EOCEOTROAISPW
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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