Exercise Training and Thrombotic Risk in Post-menopausal Women

NCT04596501 | Unknown DMC

• 1 other identifier: Thrombosis in PM Women
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Thrombosis; Menopause; Exercise Training; Vascular Dilation

Outcome Measures

Primary Outcomes (8)

• Changes in clot microstructure in early and late postmenopausal women after 16 weeks of exercise training

  Clot microstructure is measured in a rheometer using unaltered whole blood

  16 weeks

• Changes in platelet reactivity in early and late postmenopausal women after 16 weeks of exercise training

  Platelet reactivity is measured with Light Transmission Aggregometry using platelet rich and platelet poor plasma

  16 weeks

• Plasma concentration of coagulation factors in early and late postmenopausal women after 16 weeks of exercise training

  Coagulation factors II, VII, X, VIII, D-dimer, fibrinogen and thrombin

  16 weeks

• Changes in vascular function in early and late postmenopausal women after 16 weeks of exercise training

  Vascular function is assessed by flow-mediated dilation (FMD) in the brachial artery using ultrasound doppler

  16 weeks

• Changes in capillary density after 16 weeks of team sports in early and late postmenopausal women

  Capillary density will be assessed by histochemistry

  16 weeks

• Changes in proliferative capacity of endothelial cells after 16 weeks of exercise training in early and late postmenopausal women

  From a biopsy sample we isolate endothelial cells and run a proliferation assay

  16 weeks

• Changes in mitochondrial function of endothelial cells after 16 weeks of exercise training in early and late postmenopausal women

  High resolution respirometry

  16 weeks

• Changes in skeletal muscle protein content important for vascular function after 16 weeks of exercise training in early and late postmenopausal women

  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.

  16 weeks

Secondary Outcomes (3)

• Changes in blood pressure after 16 weeks of team sports in early and late postmenopausal women

  16 weeks

• Changes in maximal oxygen uptake after 16 weeks of team sports in early and late postmenopausal women

  16 weeks

• Changes in body composition after 16 weeks of team sports in early and late postmenopausal women

  16 Weeks

Study Arms (2)

Early postmenopausal women

EXPERIMENTAL

Healthy sedentary early postmenopausal women

Other: Early and late postmenopausal women

Late postmenopausal women

EXPERIMENTAL

Healthy sedentary late postmenopausal women

Other: Early and late postmenopausal women

Interventions

Early and late postmenopausal women OTHER

The intervention involves supervised team sports 1 h 3 x/week for 16 weeks.

Early postmenopausal women; Late postmenopausal women

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Copenhagen: lead
• Swansea University: collaborator

Study Sites (1)

Ylva Hellsten

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ylva Hellsten, Dr.Med.Sci.

  Nutrition, Exercise and Sports, 2200 Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

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 8, 2020
• First Posted: October 22, 2020
• Study Start: March 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 31, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)