Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Exercise Training and Thrombotic Risk in Post-menopausal Women (TIME)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04596501
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : October 26, 2021
Sponsor:
Collaborator:
Swansea University
Information provided by (Responsible Party):
Ylva Hellsten, University of Copenhagen

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

At menopausal transition, the risk of cardiovascular diseases increases. This is partly due to aging, but largely also the loss of estrogen, which has many positive effects on the circulation and protects against cardiovascular diseases. It has been suggested that the loss of estrogen may have a negative impact on the otherwise well-documented health promoting effects of exercise training, and that the time after menopause may be crucial for the effect of exercise training on the vascular function, and therefore also for the risk of thrombosis. Literature regarding the effect of exercise training on the risk of thrombosis is limited, and especially in women.

The purpose of the present study is to investigate whether the same effects of exercise training in relation to thrombosis is achieved if the exercise is initiated early compared to late after menopause. The aim is to provide knowledge-based recommendations regarding exercise. Teams sports will be used as the training intervention, because team sports benefits physical health and also includes a social element.


Condition or disease Intervention/treatment Phase
Thrombosis Menopause Exercise Training Vascular Dilation Other: Early and late postmenopausal women Not Applicable

Detailed Description:
Part of the novelty of this project is to link functional measurements of cardiovascular health at whole body level to cell studies. Cells will be isolated from muscle samples obtained from the post-menopausal women before and after the training intervention. This will enhance the understanding of the changes that occur after prolonged loss of estrogen on thrombotic risk and vascular function, and whether exercise training can alter these parameters.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Susceptibility to Thrombosis in Post-menopausal Women- Influence of Exercise Training
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : March 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Early postmenopausal women
Healthy sedentary early postmenopausal women
 Other: Early and late postmenopausal women
The intervention involves supervised team sports 1 h 3 x/week for 16 weeks.
Experimental: Late postmenopausal women
Healthy sedentary late postmenopausal women
 Other: Early and late postmenopausal women
The intervention involves supervised team sports 1 h 3 x/week for 16 weeks.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Changes in clot microstructure in early and late postmenopausal women after 16 weeks of exercise training [ Time Frame: 16 weeks ]
    Clot microstructure is measured in a rheometer using unaltered whole blood

  2. Changes in platelet reactivity in early and late postmenopausal women after 16 weeks of exercise training [ Time Frame: 16 weeks ]
    Platelet reactivity is measured with Light Transmission Aggregometry using platelet rich and platelet poor plasma

  3. Plasma concentration of coagulation factors in early and late postmenopausal women after 16 weeks of exercise training [ Time Frame: 16 weeks ]
    Coagulation factors II, VII, X, VIII, D-dimer, fibrinogen and thrombin

  4. Changes in vascular function in early and late postmenopausal women after 16 weeks of exercise training [ Time Frame: 16 weeks ]
    Vascular function is assessed by flow-mediated dilation (FMD) in the brachial artery using ultrasound doppler

  5. Changes in capillary density after 16 weeks of team sports in early and late postmenopausal women [ Time Frame: 16 weeks ]
    Capillary density will be assessed by histochemistry

  6. Changes in proliferative capacity of endothelial cells after 16 weeks of exercise training in early and late postmenopausal women [ Time Frame: 16 weeks ]
    From a biopsy sample we isolate endothelial cells and run a proliferation assay

  7. Changes in mitochondrial function of endothelial cells after 16 weeks of exercise training in early and late postmenopausal women [ Time Frame: 16 weeks ]
    High resolution respirometry

  8. Changes in skeletal muscle protein content important for vascular function after 16 weeks of exercise training in early and late postmenopausal women [ Time Frame: 16 weeks ]
    Western blots will be used to determine endothelial nitric oxide synthase (eNOS), cyclo-oxygenase 1 and 2, prostacyclin synthase, endothelin receptor A and B, VEGF (vascular endothelial growth factor), Thrombospondin-1, Flk-1 (VEGF receptor). All protein content measures will be presented as arbitrary units.


Secondary Outcome Measures :
  1. Changes in blood pressure after 16 weeks of team sports in early and late postmenopausal women [ Time Frame: 16 weeks ]
    Blood pressure measured at home with an automated blood pressure device. Systolic blood pressure, diastolic blood pressure and mean arterial pressure will be collected.

  2. Changes in maximal oxygen uptake after 16 weeks of team sports in early and late postmenopausal women [ Time Frame: 16 weeks ]
    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.

  3. Changes in body composition after 16 weeks of team sports in early and late postmenopausal women [ Time Frame: 16 Weeks ]
    Dual-energy x-ray absorptiometry (DXA) will be 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)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age: 50-70 years
  • Physical activity ≤ 2 hours per week (except transportation by bike or by walking)
  • BMI ≤ 30

Exclusion Criteria:

  • Age <50 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
  • Not entered menopause
  • 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04596501


Contacts
Layout table for location contacts
Contact: Ylva Hellsten, Dr.Med.Sc. +4535321616 yhellsten@nexs.ku.dk
Contact: Line N Olsen, MSc +4535326646 lno@nexs.ku.dk

Locations
Layout table for location information
Denmark
Ylva Hellsten Recruiting
Copenhagen, Denmark, 2100
Contact: Ylva Hellsten, Dr.Med.Sc.    35321616    yhellsten@nexs.ku.dk   
Contact: Line Olsen, MSc       lno@nexs.ku.dk   
Sponsors and Collaborators
University of Copenhagen
Swansea University
Investigators
Layout table for investigator information
Principal Investigator: Ylva Hellsten, Dr.Med.Sci. Nutrition, Exercise and Sports, 2200 Copenhagen, Denmark
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Ylva Hellsten, Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT04596501    
Other Study ID Numbers: Thrombosis in PM Women
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: October 26, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases