The Effect of Team Sports on the Risk of Thrombosis in Elderly Individuals in a Municipality Setting (TEAM-AGE)
TEAM-AGE
1 other identifier
interventional
400
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2024
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2020
CompletedFirst Posted
Study publicly available on registry
November 2, 2020
CompletedStudy Start
First participant enrolled
December 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
May 11, 2023
May 1, 2023
2 years
October 26, 2020
May 9, 2023
Conditions
Outcome Measures
Primary Outcomes (5)
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
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
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
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
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
12 months
Secondary Outcomes (3)
Changes in blood pressure after 16 weeks and 1 year of team sports in local sports clubs, respectively, in elderly individuals
12 months
Changes in maximal oxygen uptake after 16 weeks and 1 year of team sports in local sports clubs, respectively, in elderly individuals
12 months
Changes in bodt composition after 16 weeks and 1 year of team sports in local sports clubs, respectively, in elderly individuals
12 months
Study Arms (2)
Team Sports
EXPERIMENTALElderly men and women performing team sports in local sports clubs
Control
EXPERIMENTALElderly men and women continue their normal lifestyle
Interventions
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
Eligibility Criteria
You may qualify if:
- Age: 60-70 years
- Physical activity ≤ 2 hours per week (except transportation by bike or by walking)
- BMI ≤ 30
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Copenhagenlead
- Swansea Universitycollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jens Bangsbo, Dr.Sci.
Nutrition, Exercise and Sports, 2200 Copenhagen, Denmark
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 26, 2020
First Posted
November 2, 2020
Study Start
December 30, 2024
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2027
Last Updated
May 11, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share