Clinical trial NCT04596501: Exercise Training and Thrombotic Risk in Post-menopausal Women
Official title: Susceptibility to Thrombosis in Post-menopausal Women- Influence of Exercise Training
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thrombosis
Menopause
Exercise Training
Vascular Dilation
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Swansea University
First posted: 2020-10-22
Enrollment: 30
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: At menopausal transition, the risk of cardiovascular diseases increases. This is partly due to aging, but largely also the loss of estrogen, which has many positive effects on the circulation and protects against cardiovascular diseases. It has been suggested that the loss of estrogen may have a negative impact on the otherwise well-documented health promoting effects of exercise training, and that the time after menopause may be crucial for the effect of exercise training on the vascular function, and therefore also for the risk of thrombosis. Literature regarding the effect of exercise training on the risk of thrombosis is limited, and especially in women.

The purpose of the present study is to investigate whether the same effects of exercise training in relation to thrombosis is achieved if the exercise is initiated early compared to late after menopause. The aim is to provide knowledge-based recommendations regarding exercise. Teams sports will be used as the training intervention, because team sports benefits physical health and also includes a social element.

Detailed description: Part of the novelty of this project is to link functional measurements of cardiovascular health at whole body level to cell studies. Cells will be isolated from muscle samples obtained from the post-menopausal women before and after the training intervention. This will enhance the understanding of the changes that occur after prolonged loss of estrogen on thrombotic risk and vascular function, and whether exercise training can alter these parameters.

Eligibility criteria: Inclusion Criteria:

* Age: 50-70 years
* Physical activity ≤ 2 hours per week (except transportation by bike or by walking)
* BMI ≤ 30

Exclusion Criteria:

* Age \<50 years
* Injuries that prevent the performance of team sports
* Participation in other clinical projects
* Smokes or has smoked within the last 10 years
* On hormone therapy
* Not entered menopause
* Has chronic diseases that are not expected, cf. the groups sought. Including heart problems, atrial fibrillation, cancer, immune diseases and previous strokes with functionally significant sequelae
* Being treated with oral steroids
* Has alcohol / drug abuse or is being treated with disulfiram (Antabus)
* Is unable to understand the contents of the document with informed consent or the experimental procedures

Primary outcomes:
measure: Changes in clot microstructure in early and late postmenopausal women after 16 weeks of exercise training
timeFrame: 16 weeks
measure: Changes in platelet reactivity in early and late postmenopausal women after 16 weeks of exercise training
timeFrame: 16 weeks
measure: Plasma concentration of coagulation factors in early and late postmenopausal women after 16 weeks of exercise training
timeFrame: 16 weeks
measure: Changes in vascular function in early and late postmenopausal women after 16 weeks of exercise training
timeFrame: 16 weeks
measure: Changes in capillary density after 16 weeks of team sports in early and late postmenopausal women
timeFrame: 16 weeks
measure: Changes in proliferative capacity of endothelial cells after 16 weeks of exercise training in early and late postmenopausal women
timeFrame: 16 weeks
measure: Changes in mitochondrial function of endothelial cells after 16 weeks of exercise training in early and late postmenopausal women
timeFrame: 16 weeks
measure: Changes in skeletal muscle protein content important for vascular function after 16 weeks of exercise training in early and late postmenopausal women
timeFrame: 16 weeks
Secondary outcomes:
measure: Changes in blood pressure after 16 weeks of team sports in early and late postmenopausal women
timeFrame: 16 weeks
measure: Changes in maximal oxygen uptake after 16 weeks of team sports in early and late postmenopausal women
timeFrame: 16 weeks
measure: Changes in body composition after 16 weeks of team sports in early and late postmenopausal women
timeFrame: 16 Weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Ylva Hellsten
Study officials:
affiliation: Nutrition, Exercise and Sports, 2200 Copenhagen, Denmark
name: Ylva Hellsten, Dr.Med.Sci.
role: PRINCIPAL_INVESTIGATOR
References: