ThrombosisTEAM-AGENCT04611191
The Effect of Team Sports on the Risk of Thrombosis in Elderly Individuals in a Municipality Setting (TEAM-AGE)
A study testing Team Sports in people with Thrombosis and Exercise Training, run by University of Copenhagen.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Thrombosis, Exercise Training, Sex Differences
- What is being tested?
- Team Sports
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 60-70 years
- Physical activity ≤ 2 hours per week (except transportation by bike or by walking)
- BMI ≤ 30
Who cannot join
- 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)
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Team Sports on the Susceptibility to Thrombosis in Elderly Men and Women in a Municipality Setting
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.
Read the 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
- Being tested
- Team Sports, Control
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Team SportsOther
The intervention involves team sports in sports clubs in local municipalities
ControlOther
The intervention involves a control condition with participants continuing their normal way of living
| Study group | Role | What they receive |
|---|---|---|
| Team Sports | Experimental | Elderly men and women performing team sports in local sports clubs Receives: Other: Team Sports |
| Control | Experimental | Elderly men and women continue their normal lifestyle Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
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.
Measured: 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.
Measured: 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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start30 Dec 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Swansea University
- Responsible party
- Principal investigator, Ylva Hellsten, University of Copenhagen
- Investigators
- Jens Bangsbo, Dr.Sci., Principal investigator, Nutrition, Exercise and Sports, 2200 Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04611191
- Sponsor's protocol ID
- Team sports and thrombosis
- Acronym
- TEAM-AGE
- Status last verified
- May 2023
- First submitted
- 26 Oct 2020
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Team Sports on the Susceptibility to Thrombosis in Elderly Men and Women in a Municipality Setting
- ClinicalTrials.gov ID
- NCT04611191
- Acronym / sponsor ID
- TEAM-AGE / Team sports and thrombosis
- Conditions
- Thrombosis, Exercise Training, Sex Differences
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Swansea University
- Study start
- 30 Dec 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Team Sports | Experimental | Other: Team SportsElderly men and women performing team sports in local sports clubs |
| Control | Experimental | Other: ControlElderly men and women continue their normal lifestyle |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 60-70 years
- Physical activity ≤ 2 hours per week (except transportation by bike or by walking)
- BMI ≤ 30
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Team SportsThe intervention involves team sports in sports clubs in local municipalities | Other | Team Sports |
| ControlThe intervention involves a control condition with participants continuing their normal way of living | Other | Control |
Primary outcome
Changes in clot microstructure in elderly individuals after 16 weeks and 1 year of team sports in local sports clubs, respectively
Time frame: 12 months
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
Time frame: 12 months
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
Time frame: 12 months
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
Time frame: 12 months
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
Time frame: 12 months
From a biopsy sample we isolate endothelial cells and run a proliferation assay
3 secondary outcomes
Changes in blood pressure after 16 weeks and 1 year of team sports in local sports clubs, respectively, in elderly individuals
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
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
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jens Bangsbo, Dr.Sci. principal investigator
Nutrition, Exercise and Sports, 2200 Copenhagen, Denmark
Questions about this trial
What is this clinical trial studying?
A study testing Team Sports in people with Thrombosis and Exercise Training, run by University of Copenhagen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ylva Hellsten, Dr.Med.Sc. (+4535321616, yhellsten@nexs.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in clot microstructure in elderly individuals after 16 weeks and 1 year of team sports in local sports clubs, respectively (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.