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Clinical Trials/NCT02135575
NCT02135575
Completed
Not Applicable

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

University of Copenhagen1 site in 1 country36 target enrollmentMay 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Menopause
Sponsor
University of Copenhagen
Enrollment
36
Locations
1
Primary Endpoint
Platelet function
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2014
End Date
July 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ylva Hellsten

Professor

University of Copenhagen

Eligibility Criteria

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

  • Excessive alcohol intake
  • Regular medication including hormone replacement treatment
  • Chronic disease

Outcomes

Primary Outcomes

Platelet function

Time Frame: Baseline comparison and changes from baseline to 3 months

Platelet aggregation assay of whole blood and platelet rich plasma

Leg vascular function

Time Frame: 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

Time Frame: Baseline comparison and changes from baseline to 3 months

Magnetic resonance imaging and transthoracic echocardiography

Secondary Outcomes

  • Expression of proteins in muscle samples(Baseline comparison and changes from baseline to 3 months)
  • Genomic profile in blood samples(Baseline comparison and changes from baseline to 3 months)
  • Gene expression of proteins in muscle samples(Baseline comparison and changes from baseline to 3 months)
  • Insulin sensitivity and glycaemic control(Baseline comparison and changes from baseline to 3 months)
  • Arterial blood pressure(Baseline comparison and changes from baseline to 3 months)
  • Maximal aerobic effect(Baseline comparison and changes from baseline to 3 months)
  • Health related parameters in blood(Baseline comparison and changes from baseline to 3 months)

Study Sites (1)

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