The Effect of Team Sports on the Risk of Thrombosis in Elderly Individuals in a Municipality Setting (TEAM-AGE) (TEAM-AGE)
Primary Purpose
Thrombosis, Exercise Training, Sex Differences
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Team Sports
Control
Sponsored by
About this trial
This is an interventional basic science trial for Thrombosis
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Team Sports
Control
Arm Description
Elderly men and women performing team sports in local sports clubs
Elderly men and women continue their normal lifestyle
Outcomes
Primary Outcome Measures
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
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
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
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
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
Secondary Outcome Measures
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.
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.
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)
Full Information
NCT ID
NCT04611191
First Posted
October 26, 2020
Last Updated
May 9, 2023
Sponsor
University of Copenhagen
Collaborators
Swansea University
1. Study Identification
Unique Protocol Identification Number
NCT04611191
Brief Title
The Effect of Team Sports on the Risk of Thrombosis in Elderly Individuals in a Municipality Setting (TEAM-AGE)
Acronym
TEAM-AGE
Official Title
The Effect of Team Sports on the Susceptibility to Thrombosis in Elderly Men and Women in a Municipality Setting
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 30, 2024 (Anticipated)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Swansea University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombosis, Exercise Training, Sex Differences
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Team Sports
Arm Type
Experimental
Arm Description
Elderly men and women performing team sports in local sports clubs
Arm Title
Control
Arm Type
Experimental
Arm Description
Elderly men and women continue their normal lifestyle
Intervention Type
Other
Intervention Name(s)
Team Sports
Intervention Description
The intervention involves team sports in sports clubs in local municipalities
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
The intervention involves a control condition with participants continuing their normal way of living
Primary Outcome Measure Information:
Title
Changes in clot microstructure in elderly individuals after 16 weeks and 1 year of team sports in local sports clubs, respectively
Description
Clot microstructure is measured in a rheometer using unaltered whole blood
Time Frame
12 months
Title
Changes in platelet reactivity in elderly individuals after 16 weeks and 1 year of team sports in local sports clubs, respectively
Description
Platelet reactivity is measured with Light Transmission Aggregometry using platelet rich and platelet poor plasma
Time Frame
12 months
Title
Plasma concentration of coagulation factors in elderly individuals after 16 weeks and 1 year of team sports in local sports clubs, respectively
Description
Coagulation factors II, VII, X, VIII, D-dimer, fibrinogen and thrombin
Time Frame
12 months
Title
Changes in capillary density in elderly individuals after 16 weeks and 1 year of team sports in local sports clubs, respectively
Description
Capillary density will be assessed by histochemistry
Time Frame
12 months
Title
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
Description
From a biopsy sample we isolate endothelial cells and run a proliferation assay
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Changes in blood pressure after 16 weeks and 1 year of team sports in local sports clubs, respectively, in elderly individuals
Description
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
Title
Changes in maximal oxygen uptake after 16 weeks and 1 year of team sports in local sports clubs, respectively, in elderly individuals
Description
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
Title
Changes in bodt composition after 16 weeks and 1 year of team sports in local sports clubs, respectively, in elderly individuals
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ylva Hellsten, Dr.Med.Sc.
Phone
+4535321616
Email
yhellsten@nexs.ku.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Line N Olsen, MSc
Phone
+4525159922
Email
lno@nexs.ku.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Bangsbo, Dr.Sci.
Organizational Affiliation
Nutrition, Exercise and Sports, 2200 Copenhagen, Denmark
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Team Sports on the Risk of Thrombosis in Elderly Individuals in a Municipality Setting (TEAM-AGE)
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