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临床试验/NCT04596501
NCT04596501进行中(未招募)不适用

Susceptibility to Thrombosis in Post-menopausal Women- Influence of Exercise Training

University of Copenhagen2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
30
试验地点
2
主要终点
Changes in proliferative capacity of endothelial cells after 16 weeks of exercise training in early and late postmenopausal women

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 16 weeks

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

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

时间窗: 16 weeks

Capillary density will be assessed by histochemistry

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

时间窗: 16 weeks

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

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

时间窗: 16 weeks

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

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

时间窗: 16 weeks

High resolution respirometry

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

时间窗: 16 weeks

Clot microstructure is measured in a rheometer using unaltered whole blood

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

时间窗: 16 weeks

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

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

时间窗: 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.

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ylva Hellsten

Professor

University of Copenhagen

研究点 (2)

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