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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
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Thrombosis

Eligibility Criteria

60 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    October 26, 2020
    Last Updated
    May 9, 2023
    Sponsor
    University of Copenhagen
    Collaborators
    Swansea University
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    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

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

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