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Exercise Training and Thrombotic Risk in Post-menopausal Women

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04596501
Acronym
TIME
Enrollment
30
Registered
2020-10-22
Start date
2021-03-01
Completion date
2023-12-31
Last updated
2023-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise Training, Menopause, Thrombosis, Vascular Dilation

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.

Interventions

OTHEREarly and late postmenopausal women

The intervention involves supervised team sports 1 h 3 x/week for 16 weeks.

Sponsors

Swansea University
CollaboratorOTHER
University of Copenhagen
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
50 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in skeletal muscle protein content important for vascular function after 16 weeks of exercise training in early and late postmenopausal women16 weeksWestern 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.
Changes in capillary density after 16 weeks of team sports in early and late postmenopausal women16 weeksCapillary density will be assessed by histochemistry
Changes in proliferative capacity of endothelial cells after 16 weeks of exercise training in early and late postmenopausal women16 weeksFrom a biopsy sample we isolate endothelial cells and run a proliferation assay
Changes in mitochondrial function of endothelial cells after 16 weeks of exercise training in early and late postmenopausal women16 weeksHigh resolution respirometry
Changes in clot microstructure in early and late postmenopausal women after 16 weeks of exercise training16 weeksClot microstructure is measured in a rheometer using unaltered whole blood
Changes in platelet reactivity in early and late postmenopausal women after 16 weeks of exercise training16 weeksPlatelet reactivity is measured with Light Transmission Aggregometry using platelet rich and platelet poor plasma
Plasma concentration of coagulation factors in early and late postmenopausal women after 16 weeks of exercise training16 weeksCoagulation factors II, VII, X, VIII, D-dimer, fibrinogen and thrombin
Changes in vascular function in early and late postmenopausal women after 16 weeks of exercise training16 weeksVascular function is assessed by flow-mediated dilation (FMD) in the brachial artery using ultrasound doppler

Secondary

MeasureTime frameDescription
Changes in blood pressure after 16 weeks of team sports in early and late postmenopausal women16 weeksBlood pressure measured at home with an automated blood pressure device. Systolic blood pressure, diastolic blood pressure and mean arterial pressure will be collected.
Changes in maximal oxygen uptake after 16 weeks of team sports in early and late postmenopausal women16 weeksMaximal oxygen uptake will be measured using a metabolic cart. The test protocol will be performed on a cycle ergometer using an incremental step test.
Changes in body composition after 16 weeks of team sports in early and late postmenopausal women16 WeeksDual-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)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026