An interventional study of Team Sports and Control in Thrombosis, Exercise Training and Sex Differences, sponsored by University of Copenhagen. Not yet recruiting. Open to participants aged 60 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-11.
Sponsored by University of Copenhagen · Not applicable, Interventional, and Basic science
Cardiovascular disease, and especially myocardial infarction, is the most common cause of death globally, and is particularly common in older individuals. Practical measures that can reduce both the prevalence and incidence of cardiovascular disease are of great value. It is well known that regular physical activity has a protective effect against the development of cardiovascular diseases such as acute myocardial infarction. It has been shown that physical activity can improve the function of the heart and blood vessels, but it is less well known how physical activity can affect the risk of formation of dangerous blood clots, and thus the risk of heart attack and stroke.
In a cross-sectional study it has been shown that a physically active lifestyle can reduce the risk of blood clot formation, but experimental evidence for the importance of a period of physical activity for the risk of blood clot formation is lacking. New methods have been set up for measuring the coagulation profile. The analyzes are performed on a blood sample and allow a thorough determination of platelet reactivity as well as an innovative measure of how the microstructure of a possible blood clot would develop. In this project, these methods is used to examine how physical activity, in the form of team sports, affects the coagulation profile of elderly men and women.
The increasing age-related risk of cardiovascular disease is associated with endothelial dysfunction and decrease in capillary density, and it has been shown that initiation of capillary growth is a successful method to treat cardiovascular disease. Therefore, this project will also investigate how a longer period of physical activity, in the form of team sports, affects capillary density and endothelial function in men and women aged 60-70 years. Both men and women will be recruited, as it is still unknown whether men and women respond differently to physical activity in relation to coagulation profile, susceptibility to blood clots and capillary density.
Cardiovascular disease, and especially myocardial infarction, is the most common cause of death globally, and is particularly common in older individuals. Practical measures that can reduce both the prevalence and incidence of cardiovascular disease are of great value. It is well known that regular physical activity has a protective effect against the development of cardiovascular diseases such as acute myocardial infarction. Therefore, the American Heart Association also recommends ≥ 30 min. per day five days a week. It has been shown that physical activity can improve the function of the heart and blood vessels, but it is less well known how physical activity can affect the risk of formation of dangerous blood clots, and thus the risk of heart attack and stroke.
In a cross-sectional study it has been shown that a physically active lifestyle can reduce the risk of blood clot formation, but experimental evidence for the importance of a period of physical activity for the risk of blood clot formation is lacking. New methods have been set up for measuring the coagulation profile. The analyzes are performed on a blood sample and allow a thorough determination of platelet reactivity as well as an innovative measure of how the microstructure of a possible blood clot would develop. In this project, these methods is used to examine how physical activity, in the form of team sports, affects the coagulation profile of elderly men and women.
The increasing age-related risk of cardiovascular disease is associated with endothelial dysfunction and decrease in capillary density, and it has been shown that initiation of capillary growth is a successful method to treat cardiovascular disease. Therefore, this project will also investigate how a longer period of physical activity, in the form of team sports, affects capillary density and endothelial function in men and women aged 60-70 years. Both men and women will be recruited, as it is still unknown whether men and women respond differently to physical activity in relation to coagulation profile, susceptibility to blood clots and capillary density.
Part of the novelty of this present study consist of 1) linking the clinical measurements with data on sickness absence, disease development, etc. and with data on the underlying mechanisms, 2) examining the short-term effect (16 weeks) and the long-term effect (up to 2 years) of physical activity, in the form of team sports in a municipality setting, on coagulation, risk of blood clots, capillarization and endothelial function in general in the elderly, as well as 3) investigate whether there is a difference in the aforementioned measurements in men and women.
1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.
This study's planned enrollment of 400 is above the median of 106 across 849 interventional studies indexed under Thrombosis.
Browse Thrombosis studies →University of Copenhagen is the lead sponsor of 450 studies on the registry; 61 are open to participants now.
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Exclusion Criteria:
Elderly men and women performing team sports in local sports clubs
Other: Team Sports
Elderly men and women continue their normal lifestyle
Other: Control
The intervention involves team sports in sports clubs in local municipalities
The intervention involves a control condition with participants continuing their normal way of living
Changes in clot microstructure in elderly individuals after 16 weeks and 1 year of team sports in local sports clubs, respectively
Clot microstructure is measured in a rheometer using unaltered whole blood
Time frame: 12 months
Changes in platelet reactivity in elderly individuals after 16 weeks and 1 year of team sports in local sports clubs, respectively
Platelet reactivity is measured with Light Transmission Aggregometry using platelet rich and platelet poor plasma
Time frame: 12 months
Plasma concentration of coagulation factors in elderly individuals after 16 weeks and 1 year of team sports in local sports clubs, respectively
Coagulation factors II, VII, X, VIII, D-dimer, fibrinogen and thrombin
Time frame: 12 months
Changes in capillary density in elderly individuals after 16 weeks and 1 year of team sports in local sports clubs, respectively
Capillary density will be assessed by histochemistry
Time frame: 12 months
Changes in proliferative capacity of endothelial cells from skeletal muscle biopsies in elderly individuals after 16 weeks and 1 year of team sports in local sports clubs, respectively
From a biopsy sample we isolate endothelial cells and run a proliferation assay
Time frame: 12 months
Changes in blood pressure after 16 weeks and 1 year of team sports in local sports clubs, respectively, in elderly individuals
In a subgroup, blood pressure (systolic blood pressure, diastolic blood pressure and mean arterial pressure) will be measured at home with an automated blood pressure device.
Time frame: 12 months
Changes in maximal oxygen uptake after 16 weeks and 1 year of team sports in local sports clubs, respectively, in elderly individuals
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.
Time frame: 12 months
Changes in bodt composition after 16 weeks and 1 year of team sports in local sports clubs, respectively, in elderly individuals
Dual-energy x-ray absorptiometry (DXA) is 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)
Time frame: 12 months
No study locations are listed for this record.
Plan to share: No
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University of Copenhagen