Effects of Exercise Training on Cardiovascular Health in Middle-aged Women

Study Overview
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Brief Summary
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The hypothesis of the present study is that physical training can oppose detrimental changes in cardiovascular and metabolic health associated with estrogen loss after menopause.

Official Title
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Effects of Exercise Training on Cardiovascular Health in Middle-aged Women

Conditions
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Menopause, Cardiac Function Impaired, Cardiovascular Diseases, Blood Platelet Disorders, Metabolic Diseases

Intervention / Treatment
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* Behavioral: Spinning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Premenopausal (45-53 years) OR postmenopausal 50-57 years BMI> 18.5 and <30 Sedentary (no regular physical activity the last 2 years) Plasma measurements Premenopausal: estradiol> 0.20 nmol/l, Follicle stimulating hormone < 22 IU/l and progesterone >2.5 nmol/l Postmenopausal: estradiol < 0.20 nmol/l, Follicle stimulating hormone > 22 IU/l and progesterone 0.3-2.5 nmol/l Exclusion Criteria: Smoking Excessive alcohol intake Regular medication including hormone replacement treatment Chronic disease

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 57 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Premenopausal women<br>The Premenopausal women are randomized to exercise by spinning (cycle) | Behavioral: Spinning<br>* After the baseline studies the pre and postmenopausal women will be randomized to spinning training groups and the intervention will last for 3 months. The spinning group will spin three times per week under guidance of a trained instructor. The training is heart rate monitored.<br>|
| Experimental: Postmenopausal women<br>The Postmenopausal women are randomized to exercise by spinning (cycle) | Behavioral: Spinning<br>* After the baseline studies the pre and postmenopausal women will be randomized to spinning training groups and the intervention will last for 3 months. The spinning group will spin three times per week under guidance of a trained instructor. The training is heart rate monitored.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leg vascular function | Measurements of leg blood flow by ultrasound doppler during exercise and during femoral arterial infusion of vasodilators | Baseline comparison and changes from baseline to 3 months | 
| Cardiac structure and function | Magnetic resonance imaging and transthoracic echocardiography | Baseline comparison and changes from baseline to 3 months | 
| Platelet function | Platelet aggregation assay of whole blood and platelet rich plasma | Baseline comparison and changes from baseline to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expression of proteins in muscle samples | Western Blot analysis of proteins of relevance for vascular function and metabolism | Baseline comparison and changes from baseline to 3 months | 
| Maximal aerobic effect | Maximal oxygen uptake during an incremental cycle ergometry test with gas analysis | Baseline comparison and changes from baseline to 3 months | 
| Genomic profile in blood samples | Genomic analysis of parameters for vascular and metabolic health | Baseline comparison and changes from baseline to 3 months | 
| Insulin sensitivity and glycaemic control | Fasting plasma glucose analysis and oral glucose tolerance test | Baseline comparison and changes from baseline to 3 months | 
| Arterial blood pressure |  | Baseline comparison and changes from baseline to 3 months | 
| Gene expression of proteins in muscle samples | Gene analysis of relevance for vascular and metabolic function | Baseline comparison and changes from baseline to 3 months | 
| Health related parameters in blood | Plasma lipid status and other variables related to vascular health | Baseline comparison and changes from baseline to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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health, premenopausal, postmenopausal, cardiovascular, exercise training, vascular function, cardiac function, cardiac morphology