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

Not Applicable

Completed

• Conditions: Menopause; Cardiovascular Diseases; Metabolic Diseases; Cardiac Function Impaired; Blood Platelet Disorders
• Interventions: Behavioral: Spinning

• Registration Number: NCT02135575
• Lead Sponsor: University of Copenhagen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-01
• Study Start: 2014-05
• Study First Submitted QC: 2014-05-06
• Study First Posted: 2014-05-12
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-14
• Last Update Posted: 2018-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Premenopausal women	Spinning	The Premenopausal women are randomized to exercise by spinning (cycle)
Postmenopausal women	Spinning	The Postmenopausal women are randomized to exercise by spinning (cycle)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Copenhagen; 🇩🇰 Copenhagen, Denmark