Exercise Training and Thrombotic Risk in Post-menopausal Women

Menopause Clinical Trial

— TIME  

Official title:

Susceptibility to Thrombosis in Post-menopausal Women- Influence of Exercise Training

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04596501
• Other study ID #: Thrombosis in PM Women
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 31, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Exercise Training
• Menopause
• Thrombosis
• Vascular Dilation

Intervention

Other:
• Early and late postmenopausal women
The intervention involves supervised team sports 1 h 3 x/week for 16 weeks.

Locations

Country	Name	City	State
Denmark	Ylva Hellsten	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Swansea University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in clot microstructure in early and late postmenopausal women after 16 weeks of exercise training	Clot microstructure is measured in a rheometer using unaltered whole blood	16 weeks
Primary	Changes in platelet reactivity in early and late postmenopausal women after 16 weeks of exercise training	Platelet reactivity is measured with Light Transmission Aggregometry using platelet rich and platelet poor plasma	16 weeks
Primary	Plasma concentration of coagulation factors in early and late postmenopausal women after 16 weeks of exercise training	Coagulation factors II, VII, X, VIII, D-dimer, fibrinogen and thrombin	16 weeks
Primary	Changes in vascular function in early and late postmenopausal women after 16 weeks of exercise training	Vascular function is assessed by flow-mediated dilation (FMD) in the brachial artery using ultrasound doppler	16 weeks
Primary	Changes in capillary density after 16 weeks of team sports in early and late postmenopausal women	Capillary density will be assessed by histochemistry	16 weeks
Primary	Changes in proliferative capacity of endothelial cells after 16 weeks of exercise training in early and late postmenopausal women	From a biopsy sample we isolate endothelial cells and run a proliferation assay	16 weeks
Primary	Changes in mitochondrial function of endothelial cells after 16 weeks of exercise training in early and late postmenopausal women	High resolution respirometry	16 weeks
Primary	Changes in skeletal muscle protein content important for vascular function after 16 weeks of exercise training in early and late postmenopausal women	Western blots will be used to determine endothelial nitric oxide synthase (eNOS), cyclo-oxygenase 1 and 2, prostacyclin synthase, endothelin receptor A and B, VEGF (vascular endothelial growth factor), Thrombospondin-1, Flk-1 (VEGF receptor). All protein content measures will be presented as arbitrary units.	16 weeks
Secondary	Changes in blood pressure after 16 weeks of team sports in early and late postmenopausal women	Blood pressure measured at home with an automated blood pressure device. Systolic blood pressure, diastolic blood pressure and mean arterial pressure will be collected.	16 weeks
Secondary	Changes in maximal oxygen uptake after 16 weeks of team sports in early and late postmenopausal women	Maximal oxygen uptake will be measured using a metabolic cart. The test protocol will be performed on a cycle ergometer using an incremental step test.	16 weeks
Secondary	Changes in body composition after 16 weeks of team sports in early and late postmenopausal women	Dual-energy x-ray absorptiometry (DXA) will be used to determine fat free mass, fat mass as well as bone mineral content. These values will be presented in absolute (g) as well as relative values (percentage)	16 Weeks