Variations in the Hemostatic System Induced by a Standardized Walking Test

NCT06418633 · tracked via the Priya Life Science France tracker

Sponsor

Centre Hospitalier Universitaire de Nīmes

Phase

Not applicable

Started

2025-02-11

Last updated

2026-06-22

Condition(s) studied

Venous Thromboembolism

Investigational drug(s) / intervention(s)

60-minute walking testStatic blood testPost-effort blood testElectrocardiogramBlood pressure monitoring

60-minute walking test: Treadmill walking test in the morning, 2 hours after breakfast, following a clinical examination, resting 12-lead electrocardiogram and blood pressure measurement. After a 3-minute warm-up and walking of speed 2.5 km per hour, no incline, the speed and incline are gradually increased to reach a target heart rate close to the theoretical ventilatory threshold, around 70% of the theoretical maximum value (evaluated by Astrand's formula: 220-age), i.e. aerobic conditions of moderate intensity so that prolonged effort can be maintained. Test performed in presence of a physician trained in stress testing. Emergency cart and defibrillator available in the department. Intra-hospital vital emergency protocol in place, with resuscitation teams on standby. The cardiology department, in the same building, can be contacted in the event of a cardiological abnormality during the test or recovery. The test takes 60 minutes, including a 3-minute initial warm-up.

Static blood test: 33.3 ml of blood will be taken from each participant whilst at rest, before undergoing the 60-minute walking test

Post-effort blood test: 33.3 ml of blood will be taken from each participant immediately after undergoing the 60-minute walking test.

Electrocardiogram: An electrocardiogram will be carried out throughout the exercise period and during the first 30 minutes of recovery.

Blood pressure monitoring: Blood pressure will be monitored out throughout the exercise period and during the first 30 minutes of recovery.

Study summary

Two groups of patients will be compared: One group of patients with a history of venous thromboembolic disease and one group without. Both groups will be subjected to a walking test and with electrocardiogram measurements and blood tests.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

Thrombin generation dosage before effort in controls — Day 0
The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM)
Thrombin generation dosage before effort in patients — Day 0
The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM)
Thrombin generation dosage after effort in controls — Day 0
The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM). The difference between measurements before and after effort will be measured in nM.min-1
Thrombin generation dosage after effort in patients — Day 0
The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM). The difference between measurements before and after effort will be measured in nM.min-1
Thrombin generation dosage before effort in the "Individual reproducibility" subgroup: controls — Day 7
The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM)
Thrombin generation dosage before effort in the "Individual reproducibility" subgroup: patients — Day 7
The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM)
Thrombin generation dosage after effort in the "Individual reproducibility" subgroup: controls — Day 7
The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM). The difference between measurements before and after effort will be measured in nM.min-1
Thrombin generation dosage after effort in the "Individual reproducibility" subgroup: patients — Day 7
The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM). The difference between measurements before and after effort will be measured in nM.min-1

Trial sites (1)

Facility	City	Region	Status
CHU de Nîmes	Nîmes	Occitanie	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06418633 on ClinicalTrials.gov ↗ ← All trials in France