Effects of a Walking Test on Blood Clotting in Patients
Variations in the Hemostatic System Induced by a Standardized Walking Test: Controls Vs. Cases with a History of Non-anticoagulated Venous Thromboembolic Disease
This study tests how a 60-minute walking test affects blood clotting in people with and without a history of blood clots.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 94 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nīmes Academic / other |
| Locations | 1 site (Nîmes, Occitanie) |
| Trial ID | NCT06418633 on ClinicalTrials.gov |
What this trial studies
This study compares two groups of patients: those with a history of venous thromboembolic disease and those without. Both groups will undergo a standardized 60-minute walking test, during which their electrocardiograms will be monitored and blood samples will be taken before and after the exercise. The aim is to assess how physical exertion influences the hemostatic system and the risk of venous thromboembolism. The findings could provide insights into the relationship between physical activity and blood clotting mechanisms.
Who should consider this trial
Good fit: Ideal candidates include patients with a history of provoked venous thromboembolism who have not required long-term anticoagulation therapy.
Not a fit: Patients with unprovoked venous thromboembolism or those currently on long-term anticoagulation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify safe levels of physical activity for patients at risk of venous thromboembolism.
How similar studies have performed: While there is some evidence linking physical activity to reduced venous thromboembolism risk, this specific approach has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Inclusion criteria common to both groups : * Patients who have given written informed consent. * Patients who are affiliated to or beneficiaries of a social security scheme. Inclusion criteria specific to the Patient Group: * Patients with a personal history of provoked venous thromboembolism, venous thrombosis and/or pulmonary embolism, with the last attack dating back to more than 6 months, and whose clinical phenotype did not justify long-term antithrombotic drug prophylaxis. Definition of provoked venous thromboembolism : The clinical criteria used to classify venous thromboembolism as provoked are : * First year of combined oestrogen-progestogen oral contraception, or contraception using an oestrogen-impregnated vaginal ring or transcutaneous synthetic oestrogen patch. * Hormonal stimulation for oocyte retrieval * Pregnancy and 6 weeks post-partum * Surgery * Trauma * Immobilisation in plaster or splint * Outbreak of acute infectious disease * Acute flare-up of inflammatory disease * Prolonged air travel lasting at least 4 hours * Prolonged strict bed rest lasting at least 3 consecutive days. Inclusion criteria specific to the Control Group: * Subjects with no personal history of venous thromboembolism * Subjects with no family history of venous thromboembolism in first-degree relatives * Subjects of the same sex and age with a tolerance of +/- 5 years in relation to the matched case. Exclusion Criteria: * Patients who are physically unable to perform the 60-minute walking test, for any reason, in particular cardiovascular contraindications to exercise (recent acute coronary syndrome unstable angina, rhythm disorders, tight aortic stenosis, cardiac heart failure, acute myocarditis, pericarditis or endocarditis endocarditis, poorly controlled hypertension, pre-stress blood pressure \> 200/110 mmHg, recent stroke or transient ischemic attack). * Patients on anticoagulant or antithrombotic treatment, ongoing or discontinued within the last month. * Patients treated for pulmonary embolism who remain dyspneic after anticoagulant treatment and requiring a work-up for pulmonary hypertension. * Last surgery dating back to less than 3 months. * Known chronic morbidities: diabetes mellitus, chronic inflammatory or infectious disease, heart failure, renal insufficiency, hepatic insufficiency or arterial thrombosis dating back to less than 3 months. * For women: treatment containing synthetic or natural estrogen, in progress or discontinued for less than a month * Pregnancy within the last year. * Difficult venous access. * Regular practice of an intensive sporting/physical activity, such as running, tennis, cycling etc. of more than 3 hours per week.
Where this trial is running
Nîmes, Occitanie
- CHU de Nîmes — Nîmes, Occitanie, France (Recruiting)
Study contacts
- Principal investigator: Antonia PEREZ MARTIN, Prof. — Nîmes University Hospital
- Study coordinator: Antonia PEREZ MARTIN, Prof.
- Email: antonia.perez.martin@chu-nimes.fr
- Phone: +334 66 68 33 13
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.