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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02135575
• Other study ID #: CWS-WP2CV
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: July 2017

Study information

• Verified date: August 2018
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 57 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Platelet Disorders
• Cardiac Function Impaired
• Cardiovascular Diseases
• Menopause
• Metabolic Diseases

Intervention

Behavioral:
• Spinning
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.

Locations

Country	Name	City	State
Denmark	University of Copenhagen	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
University of Copenhagen	Glostrup University Hospital, Copenhagen, Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anthropometry	Dual x-ray absorptiometry, height, weight, waist and hip circumference	Baseline comparison and changes from baseline to 3 months
Other	Activity measure	Activity measure for one week by accelerometer	Baseline comparison and changes from baseline to 3 months
Primary	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
Primary	Cardiac structure and function	Magnetic resonance imaging and transthoracic echocardiography	Baseline comparison and changes from baseline to 3 months
Primary	Platelet function	Platelet aggregation assay of whole blood and platelet rich plasma	Baseline comparison and changes from baseline to 3 months
Secondary	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
Secondary	Maximal aerobic effect	Maximal oxygen uptake during an incremental cycle ergometry test with gas analysis	Baseline comparison and changes from baseline to 3 months
Secondary	Genomic profile in blood samples	Genomic analysis of parameters for vascular and metabolic health	Baseline comparison and changes from baseline to 3 months
Secondary	Insulin sensitivity and glycaemic control	Fasting plasma glucose analysis and oral glucose tolerance test	Baseline comparison and changes from baseline to 3 months
Secondary	Arterial blood pressure		Baseline comparison and changes from baseline to 3 months
Secondary	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
Secondary	Health related parameters in blood	Plasma lipid status and other variables related to vascular health	Baseline comparison and changes from baseline to 3 months