Skip to main content
OpenTrials
Completed

NCT Number: NCT02135575

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Menopause Blood Platelet Disorders Cardiac Function Impaired Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

45 year–57 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Copenhagen

Copenhagen, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spinning

Behavioral

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.

Primary outcomes

  1. 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

  2. Cardiac structure and function

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

    Magnetic resonance imaging and transthoracic echocardiography

  3. Platelet function

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

    Platelet aggregation assay of whole blood and platelet rich plasma

Secondary outcomes

  1. Expression of proteins in muscle samples

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

    Western Blot analysis of proteins of relevance for vascular function and metabolism

  2. Maximal aerobic effect

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

    Maximal oxygen uptake during an incremental cycle ergometry test with gas analysis

  3. Genomic profile in blood samples

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

    Genomic analysis of parameters for vascular and metabolic health

  4. Insulin sensitivity and glycaemic control

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

    Fasting plasma glucose analysis and oral glucose tolerance test

  5. Arterial blood pressure

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

  6. Gene expression of proteins in muscle samples

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

    Gene analysis of relevance for vascular and metabolic function

  7. Health related parameters in blood

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

    Plasma lipid status and other variables related to vascular health

Other outcomes

  1. Anthropometry

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

    Dual x-ray absorptiometry, height, weight, waist and hip circumference

  2. Activity measure

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

    Activity measure for one week by accelerometer

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Glostrup University Hospital, Copenhagen
  • Rigshospitalet, Denmark

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 12, 2014
Registry last updated
Aug 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.