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

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University of Copenhagen

Status

Active, not recruiting

Conditions

Exercise Training
Menopause
Thrombosis
Vascular Dilation

Treatments

Other: Early and late postmenopausal women

Study type

Interventional

Funder types

Other

Identifiers

NCT04596501
Thrombosis in PM Women

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

Female

Ages

50 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

Early postmenopausal women
Experimental group
Description:
Healthy sedentary early postmenopausal women
Treatment:
Other: Early and late postmenopausal women
Late postmenopausal women
Experimental group
Description:
Healthy sedentary late postmenopausal women
Treatment:
Other: Early and late postmenopausal women

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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