The Effect of Team Sports on the Risk of Thrombosis in Elderly Individuals in a Municipality Setting (TEAM-AGE)

NCT ID: NCT04611191

Last Updated: 2023-05-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-30
• Study Completion Date: 2027-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Thrombosis; Exercise Training; Sex Differences

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Team Sports

Elderly men and women performing team sports in local sports clubs

Group Type: EXPERIMENTAL

Team Sports

Intervention Type: OTHER

The intervention involves team sports in sports clubs in local municipalities

Control

Elderly men and women continue their normal lifestyle

Group Type: EXPERIMENTAL

Control

Intervention Type: OTHER

The intervention involves a control condition with participants continuing their normal way of living

Interventions

Team Sports

The intervention involves team sports in sports clubs in local municipalities

Intervention Type: OTHER

Control

The intervention involves a control condition with participants continuing their normal way of living

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age: 60-70 years
• Physical activity ≤ 2 hours per week (except transportation by bike or by walking)
• BMI ≤ 30

Exclusion Criteria

• Age <60 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 (women)
• Not entered menopause (women)
• 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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Swansea University

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Ylva Hellsten

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jens Bangsbo, Dr.Sci.

Role: PRINCIPAL_INVESTIGATOR

Nutrition, Exercise and Sports, 2200 Copenhagen, Denmark

Central Contacts

Ylva Hellsten, Dr.Med.Sc.

Role: CONTACT

yhellsten@nexs.ku.dk

+4535321616

Line N Olsen, MSc

Role: CONTACT

lno@nexs.ku.dk

+4525159922

Other Identifiers

Team sports and thrombosis

Identifier Type: -

Identifier Source: org_study_id