Exercise Training and Thrombotic Risk in Post-menopausal Women

NCT ID: NCT04596501

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2023-12-31

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.

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.

Conditions

Thrombosis; Menopause; Exercise Training; Vascular Dilation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Early postmenopausal women

Healthy sedentary early postmenopausal women

Group Type: EXPERIMENTAL

Early and late postmenopausal women

Intervention Type: OTHER

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

Late postmenopausal women

Healthy sedentary late postmenopausal women

Group Type: EXPERIMENTAL

Early and late postmenopausal women

Intervention Type: OTHER

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

Interventions

Early and late postmenopausal women

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Swansea University

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Ylva Hellsten

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ylva Hellsten, Dr.Med.Sci.

Role: PRINCIPAL_INVESTIGATOR

Nutrition, Exercise and Sports, 2200 Copenhagen, Denmark

Locations

Ylva Hellsten

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

Thrombosis in PM Women

Identifier Type: -

Identifier Source: org_study_id