Clinical trial NCT02135575: Effects of Exercise Training on Cardiovascular Health in Middle-aged Women
Official title: Effects of Exercise Training on Cardiovascular Health in Middle-aged Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Cardiac Function Impaired
Cardiovascular Diseases
Blood Platelet Disorders
Metabolic Diseases
Keywords: premenopausal
postmenopausal
cardiovascular
exercise training
vascular function
cardiac function
cardiac morphology
health
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Glostrup University Hospital, Copenhagen
name: Rigshospitalet, Denmark
First posted: 2014-05-12
Enrollment: 36
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 57
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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:

* Smoking
* Excessive alcohol intake
* Regular medication including hormone replacement treatment
* Chronic disease

Primary outcomes:
measure: Leg vascular function
timeFrame: Baseline comparison and changes from baseline to 3 months
measure: Cardiac structure and function
timeFrame: Baseline comparison and changes from baseline to 3 months
measure: Platelet function
timeFrame: Baseline comparison and changes from baseline to 3 months
Secondary outcomes:
measure: Expression of proteins in muscle samples
timeFrame: Baseline comparison and changes from baseline to 3 months
measure: Maximal aerobic effect
timeFrame: Baseline comparison and changes from baseline to 3 months
measure: Genomic profile in blood samples
timeFrame: Baseline comparison and changes from baseline to 3 months
measure: Insulin sensitivity and glycaemic control
timeFrame: Baseline comparison and changes from baseline to 3 months
measure: Arterial blood pressure
timeFrame: Baseline comparison and changes from baseline to 3 months
measure: Gene expression of proteins in muscle samples
timeFrame: Baseline comparison and changes from baseline to 3 months
measure: Health related parameters in blood
timeFrame: Baseline comparison and changes from baseline to 3 months
Other outcomes:
measure: Anthropometry
timeFrame: Baseline comparison and changes from baseline to 3 months
measure: Activity measure
timeFrame: Baseline comparison and changes from baseline to 3 months
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen
Study officials:
affiliation: University of Copenhagen
name: Erik Richter, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Egelund J, Jorgensen PG, Mandrup CM, Fritz-Hansen T, Stallknecht B, Bangsbo J, Nyberg M, Hellsten Y. Cardiac Adaptations to High-Intensity Aerobic Training in Premenopausal and Recent Postmenopausal Women: The Copenhagen Women Study. J Am Heart Assoc. 2017 Aug 18;6(8):e005469. doi: 10.1161/JAHA.117.005469.