ThrombosisTIMENCT04596501
Exercise Training and Thrombotic Risk in Post-menopausal Women
A study testing Early and late postmenopausal women in people with Thrombosis and Menopause, run by University of Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Thrombosis, Menopause, Exercise Training
- What is being tested?
- Early and late postmenopausal women
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 50-70 years
- Physical activity ≤ 2 hours per week (except transportation by bike or by walking)
- BMI ≤ 30
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Susceptibility to Thrombosis in Post-menopausal Women- Influence of Exercise Training
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.
Read the 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
- Being tested
- Early and late postmenopausal women
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early and late postmenopausal womenOther
The intervention involves supervised team sports 1 h 3 x/week for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Early postmenopausal women | Experimental | Healthy sedentary early postmenopausal women Receives: Other: Early and late postmenopausal women |
| Late postmenopausal women | Experimental | Healthy sedentary late postmenopausal women Receives: Other: Early and late postmenopausal women |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 16 weeks
Changes in mitochondrial function of endothelial cells after 16 weeks of exercise training in early and late postmenopausal women
High resolution respirometry
Measured: 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.
Measured: 16 weeks
Secondary outcomes (3)
Changes in blood pressure after 16 weeks of team sports in early and late postmenopausal women
Blood pressure measured at home with an automated blood pressure device. Systolic blood pressure, diastolic blood pressure and mean arterial pressure will be collected.
Measured: 16 weeks
Changes in maximal oxygen uptake after 16 weeks of team sports in early and late postmenopausal women
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.
Measured: 16 weeks
Changes in body composition after 16 weeks of team sports in early and late postmenopausal women
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)
Measured: 16 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Mar 2021
- Primary completion1 Dec 2022
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Swansea University
- Responsible party
- Principal investigator, Ylva Hellsten, University of Copenhagen
- Investigators
- Ylva Hellsten, Dr.Med.Sci., Principal investigator, Nutrition, Exercise and Sports, 2200 Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596501
- Sponsor's protocol ID
- Thrombosis in PM Women
- Acronym
- TIME
- Status last verified
- May 2023
- First submitted
- 8 Oct 2020
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Norregaard LB, Hansen CC, Wickham KA, Moller S, Olsen K, Ehlers T, Bangsbo J, Hellsten Y. Exercise training alters skeletal muscle microvascular endothelial cell properties in recent postmenopausal females. J Physiol. 2024 Jul;602(14):3449-3468. doi: 10.1113/JP286269. Epub 2024 Jun 1.
PubMed 38822814
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Susceptibility to Thrombosis in Post-menopausal Women- Influence of Exercise Training
- ClinicalTrials.gov ID
- NCT04596501
- Acronym / sponsor ID
- TIME / Thrombosis in PM Women
- Conditions
- Thrombosis, Menopause, Exercise Training, Vascular Dilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Swansea University
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early postmenopausal women | Experimental | Other: Early and late postmenopausal womenHealthy sedentary early postmenopausal women |
| Late postmenopausal women | Experimental | Other: Early and late postmenopausal womenHealthy sedentary late postmenopausal women |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 50-70 years
- Physical activity ≤ 2 hours per week (except transportation by bike or by walking)
- BMI ≤ 30
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early and late postmenopausal womenThe intervention involves supervised team sports 1 h 3 x/week for 16 weeks. | Other | Early postmenopausal women, Late postmenopausal women |
Primary outcome
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
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
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
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
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
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
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
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.
3 secondary outcomes
Changes in blood pressure after 16 weeks of team sports in early and late postmenopausal women
Time frame: 16 weeks
Changes in maximal oxygen uptake after 16 weeks of team sports in early and late postmenopausal women
Time frame: 16 weeks
Changes in body composition after 16 weeks of team sports in early and late postmenopausal women
Time frame: 16 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Derived from this study: PubMed 38822814Norregaard LB, Hansen CC, Wickham KA, Moller S, Olsen K, Ehlers T, Bangsbo J, Hellsten Y. Exercise training alters skeletal muscle microvascular endothelial cell properties in recent postmenopausal females. J Physiol. 2024 Jul;602(14):3449-3468. doi: 10.1113/JP286269. Epub 2024 Jun 1.
- Individual participant dataSharing planned: No
Related trials for Thrombosis
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
RecruitingObservational study
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
Pulmonary Embolism
RecruitingPhase 2
SBRT With Immunotherapy and Atezo-Bev in HCC With Major Portal Vein Thrombosis
HCC
Not yet recruiting
Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism
Pulmonary Embolism (PE), Pulmonary Embolism With Right Ventricle Enlargement
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ylva Hellsten, Dr.Med.Sci. principal investigator
Nutrition, Exercise and Sports, 2200 Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early and late postmenopausal women in people with Thrombosis and Menopause, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in clot microstructure in early and late postmenopausal women after 16 weeks of exercise training (time frame: 16 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04596501, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.