Variations in the Hemostatic System Induced by a Standardized Walking Test (FAST&THROMBIN)

Variations in the Hemostatic System Induced by a Standardized Walking Test: Controls vs. Cases With a History of Non-anticoagulated Venous Thromboembolic Disease

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Venous Thromboembolism
• Intervention / Treatment: Other: 60-minute walking test; Diagnostic test: Static blood test; Diagnostic test: Post-effort blood test; Other: Electrocardiogram; Other: Blood pressure monitoring

Detailed Description

Induced venous thromboembolism is a situation in which venous thromboembolic disease is triggered by an acute event that activates hemostasis: surgery, trauma, infectious or inflammatory outbreak, etc., a situation in which the risk of spontaneous recurrence, in the absence of a new provoking circumstance, is low, leading to the suggestion, not of long-term thromboprophylaxis, but simply the transient prevention of an event when there is a new clinical event likely to activate hemostasis. One such event is acute physical exertion.

Indeed, cohort studies seem to show that regular physical activity is associated with a low incidence of venous thromboembolism. Trained individuals have an endogenous thrombotic potential, assessed by the thrombin TGT test, lower than that of sedentary controls. A 3-month regimen of daily endurance exercise reduces thrombin generation controls and optimizes the fibrinolytic system. Repetitive exercise is accompanied by a depletion of exercise-induced platelet activation. However, several cases of venous thromboembolism have been reported in high-level athletes without usual risk factors and acute high-intensity rowing induces an acute increase in thrombin generation immediately after exercise, which disappears within 16 to 24 hours. The relationship between the level of physical activity and the risk of VTE could be a U-shaped relation, with an increasing risk of event in intense acute practice.

However, no data exists on the hemostatic impact of an acute session of physical activity in patients with a history of venous thromboembolism. Thus, the hypothesis is that exercise-induced response of hemostasis differ in patients with an history of provoked VTE compared to subjects without a history of venous thromboembolism.

This is a proof-of-concept, pathophysiological, single-center, cross-sectional, prospective comparison study of a group of patients with a personal history of induced Venous thromboembolism to a group of sex- and age- and sex-matched controls (+/- 5 years).

- Type of clinical study: Stress test-induced variations in parameters describing the results of the thrombin generation test (Thromboscreen®) in a group of Patients (Cases) will be compared with those obtained in a group of Control subjects (Controls) with a ratio 1:1.

The Patients group comprises 47 patients with a personal history of induced venous thromboembolism, the last event dating back to more than 6 months, whose clinical phenotype did not justify long-term antithrombotic drug prophylaxis.The Control group comprises 47 patients with no personal history of venous thromboembolism and no family history of venous thromboembolism in first-degree relatives.

The study intervention consists of an hour-long walking test and two blood tests in both groups for all participants (Controls and Patients).

- Intra-individual reproducibility will be analyzed in 20 subjects (10 patients and 10 controls) who will take the walking test twice on two separate days.

Patients will be selected during a venous thromboembolism follow-up consultation by a physician from either department (Vascular Medicine Consultation or Biological Hematology and Consultations).Inclusion and non-inclusion criteria will be checked, and the study will be explained to participants (patients and controls).Patients and controls will be systematically asked to take part in the variability analysis on a voluntary basis, until 10 subjects per group have agreed to carry out the second test.

The walking test is performed in the morning, 2 hours after a standard breakfast, on a treadmill. It will be preceded by a clinical examination, a resting 12-lead electrocardiogram and a brachial pressure measurement. After a 3-minute warm-up and "habituation" period (walking speed 2.5 km per hour with no incline), the speed and incline will be gradually increased until a target heart rate close to the theoretical ventilatory threshold, and of the order of 70% of the theoretical maximum value (evaluated by Astrand's formula: 220-age), so as to maintain aerobic exercise conditions of moderate intensity, enabling prolonged effort to be maintained. Blood samples will be taken from each participant whilst at rest, before undergoing the 60-minute walking test, in a sitting position, and just after the exercise test.

• Study Type: Interventional
• Enrollment (Estimated): 94
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anissa MEGZARI; Phone Number: +33466684236; Email: drc@chu-nimes.fr
• Study Contact Backup: Name: Antonia PEREZ MARTIN, Prof.; Phone Number: +334 66 68 33 13; Email: antonia.perez.martin@chu-nimes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Subjects with neither a personal history nor family history of venous thromboembolism in first-degree relatives.	Other: 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.; Diagnostic test: Static blood test; 33.3 ml of blood will be taken from each participant whilst at rest, before undergoing the 60-minute walking test; Diagnostic test: Post-effort blood test; 33.3 ml of blood will be taken from each participant immediately after undergoing the 60-minute walking test.; Other: Electrocardiogram; An electrocardiogram will be carried out throughout the exercise period and during the first 30 minutes of recovery.; Other: Blood pressure monitoring; Blood pressure will be monitored out throughout the exercise period and during the first 30 minutes of recovery.
Active Comparator: Patients; Patients with a personal history of induced venous thromboembolism, the last attack dating back to more than 6 months, whose clinical phenotype did not justify long-term antithrombotic drug prophylaxis	Other: 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.; Diagnostic test: Static blood test; 33.3 ml of blood will be taken from each participant whilst at rest, before undergoing the 60-minute walking test; Diagnostic test: Post-effort blood test; 33.3 ml of blood will be taken from each participant immediately after undergoing the 60-minute walking test.; Other: Electrocardiogram; An electrocardiogram will be carried out throughout the exercise period and during the first 30 minutes of recovery.; Other: Blood pressure monitoring; Blood pressure will be monitored out throughout the exercise period and during the first 30 minutes of recovery.
Active Comparator: Individual reproducibility" subgroup: controls; 10 subjects with neither a personal history nor family history of venous thromboembolism in first-degree relatives who have accepted to re-do the test one week later.	Other: 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.; Diagnostic test: Static blood test; 33.3 ml of blood will be taken from each participant whilst at rest, before undergoing the 60-minute walking test; Diagnostic test: Post-effort blood test; 33.3 ml of blood will be taken from each participant immediately after undergoing the 60-minute walking test.; Other: Electrocardiogram; An electrocardiogram will be carried out throughout the exercise period and during the first 30 minutes of recovery.; Other: Blood pressure monitoring; Blood pressure will be monitored out throughout the exercise period and during the first 30 minutes of recovery.
Active Comparator: Individual reproducibility" subgroup: patients; 10 patients with a history of induced venous thromboembolism, the last attack dating back to more than 6 months, whose clinical phenotype did not justify long-term antithrombotic drug prophylaxis, who have accepted to re-do the test one week later.	Other: 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.; Diagnostic test: Static blood test; 33.3 ml of blood will be taken from each participant whilst at rest, before undergoing the 60-minute walking test; Diagnostic test: Post-effort blood test; 33.3 ml of blood will be taken from each participant immediately after undergoing the 60-minute walking test.; Other: Electrocardiogram; An electrocardiogram will be carried out throughout the exercise period and during the first 30 minutes of recovery.; Other: Blood pressure monitoring; Blood pressure will be monitored out throughout the exercise period and during the first 30 minutes of recovery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thrombin generation dosage before effort in controls	The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM)	Day 0
Thrombin generation dosage before effort in patients	The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM)	Day 0
Thrombin generation dosage after effort in controls	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	Day 0
Thrombin generation dosage after effort in patients	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	Day 0
Thrombin generation dosage before effort in the "Individual reproducibility" subgroup: controls	The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM)	Day 7
Thrombin generation dosage before effort in the "Individual reproducibility" subgroup: patients	The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM)	Day 7
Thrombin generation dosage after effort in the "Individual reproducibility" subgroup: controls	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	Day 7
Thrombin generation dosage after effort in the "Individual reproducibility" subgroup: patients	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	Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution in the Control group	Measurements in nM.min-1 will be compared to elicit central tendency, dispersion and heterogeneity in the Control group	Day 0
Distribution in the Patient group	Measurements in nM.min-1 will be compared to elicit central tendency, dispersion and heterogeneity in the Patient group	Day 0
Thromboscreen test in Controls in the absence of thrombomodulin : Latency time	Latency time in the absence of thrombomodulin will be measured in seconds in Controls.	Day 0
Thromboscreen test in Controls in the absence of thrombomodulin : Thrombin peak intensity	Thrombin peak intensity in the absence of thrombomodulin will be measured in Controls.	Day 0
Thromboscreen test in Controls in the absence of thrombomodulin : Time-to-peak thrombin	Time-to-peak thrombin in the absence of thrombomodulin will be measured in Controls.	Day 0
Thromboscreen test in Controls in the absence of thrombomodulin : Initial thrombin generation velocity	Initial thrombin generation velocity in the absence of thrombomodulin will be measured in seconds in Controls.	Day 0
Thromboscreen test in Controls in the absence of thrombomodulin : Time to return to baseline	Time to return to baseline in the absence of thrombomodulin will be measured in seconds in Controls.	Day 0
Thromboscreen test in Controls in the presence of thrombomodulin : Latency time	Latency time in the presence of thrombomodulin will be measured in seconds in Controls.	Day 0
Thromboscreen test in Controls in the presence of thrombomodulin : Thrombin peak intensity	Thrombin peak intensity in the presence of thrombomodulin will be measured in Controls.	Day 0
Thromboscreen test in Controls in the presence of thrombomodulin : Time-to-peak thrombin	Time-to-peak thrombin in the presence of thrombomodulin will be measured in Controls.	Day 0
Thromboscreen test in Controls in the presence of thrombomodulin : Initial thrombin generation velocity	Initial thrombin generation velocity in the presence of thrombomodulin will be measured in seconds in Controls.	Day 0
Thromboscreen test in Controls in the presence of thrombomodulin : Time to return to baseline	Time to return to baseline in the presence of thrombomodulin will be measured in seconds in Controls.	Day 0
Thromboscreen test in Patients in the absence of thrombomodulin : Latency time	Latency time in the absence of thrombomodulin will be measured in seconds in Patients.	Day 0
Thromboscreen test in Patients in the absence of thrombomodulin : Thrombin peak intensity	Thrombin peak intensity in the absence of thrombomodulin will be measured in Patients.	Day 0
Thromboscreen test in Patients in the absence of thrombomodulin : Time-to-peak thrombin	Time-to-peak thrombin, initial thrombin generation velocity, time to return to baseline for the thrombin generation test performed in the absence of thrombomodulin will be measured in seconds in Patients.	Day 0
Thromboscreen test in Patients in the absence of thrombomodulin : Initial thrombin generation velocity	Initial thrombin generation velocity in the absence of thrombomodulin will be measured in seconds in Patients.	Day 0
Thromboscreen test in Patients in the absence of thrombomodulin : Time to return to baseline	Time to return to baseline in the absence of thrombomodulin will be measured in seconds in Patients.	Day 0
Thromboscreen test in Patients in the presence of thrombomodulin : Latency time	Latency time in the presence of thrombomodulin will be measured in seconds in Patients.	Day 0
Thromboscreen test in Patients in the presence of thrombomodulin : Thrombin peak intensity	Thrombin peak intensity in the presence of thrombomodulin will be measured in seconds in Patients.	Day 0
Thromboscreen test in Patients in the presence of thrombomodulin : Time-to-peak thrombin	Time-to-peak thrombin in the presence of thrombomodulin be measured in seconds in Patients.	Day 0
Thromboscreen test in Patients in the presence of thrombomodulin : Initial thrombin generation velocity	Initial thrombin generation velocity in the presence of thrombomodulin will be measured in seconds in Patients.	Day 0
Thromboscreen test in Patients in the presence of thrombomodulin : Time to return to baseline	Time to return to baseline in the presence of thrombomodulin will be measured in seconds in Patients.	Day 0
Distribution of other parameters of the Thromboscreen test in Controls	The distribution (central tendency, dispersion, heterogeneity), of the various biological parameters (latency time, thrombin peak intensity, time-to-peak thrombin, initial thrombin generation velocity, time to return to baseline) will be measured in Controls	Day 0
Distribution of other parameters of the Thromboscreen test in Patients	The distribution (central tendency, dispersion, heterogeneity), of the various biological parameters (latency time, thrombin peak intensity, time-to-peak thrombin, initial thrombin generation velocity, time to return to baseline) will be measured in Patients	Day 0
Endogenous Thrombotic Potential in the presence of thrombomodulin in Controls	nM.min	Day 0
Endogenous Thrombotic Potential in the absence of thrombomodulin in Controls	nM.min	Day 0
Endogenous Thrombotic Potential in the presence of thrombomodulin in Patients	nM.min	Day 0
Endogenous Thrombotic Potential in the absence of thrombomodulin in Patients	nM.min	Day 0
Heterogeneity of Endogenous Thrombotic Potential in Controls	Statistical analysis, Cochrane's Q test	Day 0
Heterogeneity of Endogenous Thrombotic Potential in Patients	Statistical analysis, Cochrane's Q test	Day 0
Complete Blood Count in Controls before the walking test: White blood cells	White blood cells will be measured in thousands/µL	Day 0
Complete Blood Count in Controls before the walking test: White blood cells	White blood cells will be measured in thousands/µL	Day 7
Complete Blood Count in Controls after the walking test: White blood cells	White blood cells will be measured in thousands/µL	Day 0
Complete Blood Count in Controls after the walking test: White blood cells	White blood cells will be measured in thousands/µL	Day 7
Complete Blood Count in Patients before the walking test: White blood cells	White blood cells will be measured in thousands/µL	Day 0
Complete Blood Count in Patients before the walking test: White blood cells	White blood cells will be measured in thousands/µL	Day 7
Complete Blood Count in Patients after the walking test: White blood cells	White blood cells will be measured in thousands/µL	Day 0
Complete Blood Count in Patients after the walking test: White blood cells	White blood cells will be measured in thousands/µL	Day 7
Complete Blood Count in Controls before the walking test: Red blood cells	Red blood cells will be measured in millions per cubic millimeter	Day 0
Complete Blood Count in Controls before the walking test: Red blood cells	Red blood cells will be measured in millions per cubic millimeter	Day 7
Complete Blood Count in Patients before the walking test: Red blood cells	Red blood cells will be measured in millions per cubic millimeter	Day 0
Complete Blood Count in Patients before the walking test: Red blood cells	Red blood cells will be measured in millions per cubic millimeter	Day 7
Complete Blood Count in Controls after the walking test: Red blood cells	Red blood cells will be measured in millions per cubic millimeter	Day 0
Complete Blood Count in Controls after the walking test: Red blood cells	Red blood cells will be measured in millions per cubic millimeter	Day 7
Complete Blood Count in Patients after the walking test: Red blood cells	Red blood cells will be measured in millions per cubic millimeter	Day 0
Complete Blood Count in Patients after the walking test: Red blood cells	Red blood cells will be measured in millions per cubic millimeter	Day 7
Complete Blood Count in Controls before the walking test:Hemaglobin	Hemaglobin will be measured in g/L	Day 0
Complete Blood Count in Controls before the walking test:Hemaglobin	Hemaglobin will be measured in g/L	Day 7
Complete Blood Count in Patients before the walking test:Hemaglobin	Hemaglobin will be measured in g/L	Day 0
Complete Blood Count in Patients before the walking test:Hemaglobin	Hemaglobin will be measured in g/L	Day 7
Complete Blood Count in Controls after the walking test: Hemaglobin	Hemaglobin will be measured in g/L	Day 0
Complete Blood Count in Controls after the walking test: Hemaglobin	Hemaglobin will be measured in g/L	Day 7
Complete Blood Count in Patients after the walking test: Hemaglobin	Hemaglobin will be measured in g/L	Day 0
Complete Blood Count in Patients after the walking test: Hemaglobin	Hemaglobin will be measured in g/L	Day 7
Complete Blood Count in Controls before the walking test: Hematocrite	Hematrocrite will be measured in L/L	Day 0
Complete Blood Count in Controls before the walking test: Hematocrite	Hematrocrite will be measured in L/L	Day 7
Complete Blood Count in Patients before the walking test: Hematocrite	Hematrocrite will be measured in L/L	Day 0
Complete Blood Count in Patients before the walking test: Hematocrite	Hematrocrite will be measured in L/L	Day 7
Complete Blood Count in Controls after the walking test: Hematocrite	Hematrocrite will be measured in L/L	Day 0
Complete Blood Count in Controls after the walking test: Hematocrite	Hematrocrite will be measured in L/L	Day 7
Complete Blood Count in Patients after the walking test: Hematocrite	Hematrocrite will be measured in L/L	Day 0
Complete Blood Count in Patients after the walking test: Hematocrite	Hematrocrite will be measured in L/L	Day 7
Complete Blood Count in Controls before the walking test: mean corpuscular volume	Mean corpuscular volume will be measured in fL	Day 0
Complete Blood Count in Controls before the walking test: mean corpuscular volume	Mean corpuscular volume will be measured in fL	Day 7
Complete Blood Count in Patients before the walking test: mean corpuscular volume	Mean corpuscular volume will be measured in fL	Day 0
Complete Blood Count in Patients before the walking test: mean corpuscular volume	Mean corpuscular volume will be measured in fL	Day 7
Complete Blood Count in Controls after the walking test: mean corpuscular volume	Mean corpuscular volume will be measured in fL	Day 0
Complete Blood Count in Controls after the walking test: mean corpuscular volume	Mean corpuscular volume will be measured in fL	Day 7
Complete Blood Count in Patients after the walking test: mean corpuscular volume	Mean corpuscular volume will be measured in fL	Day 0
Complete Blood Count in Patients after the walking test: mean corpuscular volume	Mean corpuscular volume will be measured in fL	Day 7
Complete Blood Count in Controls before the walking test: mean corpuscular hemoglobin	Mean Corpuscular Hemoglobin will be measured in pg	Day 0
Complete Blood Count in Controls before the walking test: mean corpuscular hemoglobin	Mean Corpuscular Hemoglobin will be measured in pg	Day 7
Complete Blood Count in Patients before the walking test: mean corpuscular hemoglobin	Mean Corpuscular Hemoglobin will be measured in pg	Day 0
Complete Blood Count in Patients before the walking test: mean corpuscular hemoglobin	Mean Corpuscular Hemoglobin will be measured in pg	Day 7
Complete Blood Count in Controls after the walking test: Mean corpuscular hemoglobin	Mean Corpuscular Hemoglobin will be measured in pg	Day 0
Complete Blood Count in Controls after the walking test: Mean corpuscular hemoglobin	Mean Corpuscular Hemoglobin will be measured in pg	Day 7
Complete Blood Count in Patients after the walking test: Mean corpuscular hemoglobin	Mean Corpuscular Hemoglobin will be measured in pg	Day 0
Complete Blood Count in Patients after the walking test: Mean corpuscular hemoglobin	Mean Corpuscular Hemoglobin will be measured in pg	Day 7
Complete Blood Count in Controls before the walking test: Mean corpuscular hemoglobin concentration	Mean Corpuscular Hemoglobin Concentration will be measured in g/L	Day 0
Complete Blood Count in Controls before the walking test: Mean corpuscular hemoglobin concentration	Mean Corpuscular Hemoglobin Concentration will be measured in g/L	Day 7
Complete Blood Count in Patients before the walking test: Mean corpuscular hemoglobin concentration	Mean Corpuscular Hemoglobin Concentration will be measured in g/L	Day 0
Complete Blood Count in Patients before the walking test: Mean corpuscular hemoglobin concentration	Mean Corpuscular Hemoglobin Concentration will be measured in g/L	Day 7
Complete Blood Count in Controls after the walking test: Mean corpuscular hemoglobin concentration	Mean Corpuscular Hemoglobin Concentration will be measured in g/L	Day 0
Complete Blood Count in Controls after the walking test: Mean corpuscular hemoglobin concentration	Mean Corpuscular Hemoglobin Concentration will be measured in g/L	Day 7
Complete Blood Count in Patients after the walking test: Mean corpuscular hemoglobin concentration	Mean Corpuscular Hemoglobin Concentration will be measured in g/L	Day 0
Complete Blood Count in Patients after the walking test: Mean corpuscular hemoglobin concentration	Mean Corpuscular Hemoglobin Concentration will be measured in g/L	Day 7
Complete Blood Count in Controls before the walking test: red cell distribution width	Red cell distribution width will be measured as %	Day 0
Complete Blood Count in Controls before the walking test: red cell distribution width	Red cell distribution width will be measured as %	Day 7
Complete Blood Count in Patients before the walking test: red cell distribution width	Red cell distribution width will be measured as %	Day 0
Complete Blood Count in Patients before the walking test: red cell distribution width	Red cell distribution width will be measured as %	Day 7
Complete Blood Count in Controls after the walking test: red cell distribution width	Red cell distribution width will be measured as %	Day 0
Complete Blood Count in Controls after the walking test: red cell distribution width	Red cell distribution width will be measured as %	Day 7
Complete Blood Count in Patients after the walking test: red cell distribution width	Red cell distribution width will be measured as %	Day 0
Complete Blood Count in Patients after the walking test: red cell distribution width	Red cell distribution width will be measured as %	Day 7
Complete Blood Count in Controls before the walking test: Platelets	Platelets will be measured in thousands/µL	Day 0
Complete Blood Count in Controls before the walking test: Platelets	Platelets will be measured in thousands/µL	Day 7
Complete Blood Count in Patients before the walking test: Platelets	Platelets will be measured in thousands/µL	Day 0
Complete Blood Count in Patients before the walking test: Platelets	Platelets will be measured in thousands/µL	Day 7
Complete Blood Count in Controls after the walking test: Platelets	Platelets will be measured in thousands/µL	Day 0
Complete Blood Count in Controls after the walking test: Platelets	Platelets will be measured in thousands/µL	Day 7
Complete Blood Count in Patients after the walking test: Platelets	Platelets will be measured in thousands/µL	Day 0
Complete Blood Count in Patients after the walking test: Platelets	Platelets will be measured in thousands/µL	Day 7
Complete Blood Count in Controls before the walking test: Neutrophils	Neutrophils will be measured in thousands/µL	Day 0
Complete Blood Count in Controls before the walking test: Neutrophils	Neutrophils will be measured in thousands/µL	Day 7
Complete Blood Count in Patients before the walking test: Neutrophils	Neutrophils will be measured in thousands/µL	Day 0
Complete Blood Count in Patients before the walking test: Neutrophils	Neutrophils will be measured in thousands/µL	Day 7
Complete Blood Count in Controls after the walking test: Neutrophils	Neutrophils will be measured in thousands/µL	Day 0
Complete Blood Count in Controls after the walking test: Neutrophils	Neutrophils will be measured in thousands/µL	Day 7
Complete Blood Count in Patients after the walking test: Neutrophils	Neutrophils will be measured in thousands/µL	Day 0
Complete Blood Count in Patients after the walking test: Neutrophils	Neutrophils will be measured in thousands/µL	Day 7
Complete Blood Count in Controls before the walking test: Lymphocytes	Lymphocytes will be measured in thousands/µL	Day 0
Complete Blood Count in Controls before the walking test: Lymphocytes	Lymphocytes will be measured in thousands/µL	Day 7
Complete Blood Count in Patients before the walking test: Lymphocytes	Lymphocytes will be measured in thousands/µL	Day 0
Complete Blood Count in Patients before the walking test: Lymphocytes	Lymphocytes will be measured in thousands/µL	Day 7
Complete Blood Count in Controls after the walking test: Lymphocytes	Lymphocytes will be measured in thousands/µL	Day 0
Complete Blood Count in Controls after the walking test: Lymphocytes	Lymphocytes will be measured in thousands/µL	Day 7
Complete Blood Count in Patients after the walking test: Lymphocytes	Lymphocytes will be measured in thousands/µL	Day 0
Complete Blood Count in Patients after the walking test: Lymphocytes	Lymphocytes will be measured in thousands/µL	Day 7
Complete Blood Count in Controls before the walking test: Monocytes	Monocytes will be measured in thousands/µL	Day 0
Complete Blood Count in Controls before the walking test: Monocytes	Monocytes will be measured in thousands/µL	Day 7
Complete Blood Count in Patients before the walking test: Monocytes	Monocytes will be measured in thousands/µL	Day 0
Complete Blood Count in Patients before the walking test: Monocytes	Monocytes will be measured in thousands/µL	Day 7
Complete Blood Count in Controls after the walking test: Monocytes	Monocytes will be measured in thousands/µL	Day 0
Complete Blood Count in Controls after the walking test: Monocytes	Monocytes will be measured in thousands/µL	Day 7
Complete Blood Count in Patients after the walking test: Monocytes	Monocytes will be measured in thousands/µL	Day 0
Complete Blood Count in Patients after the walking test: Monocytes	Monocytes will be measured in thousands/µL	Day 7
Complete Blood Count in Controls before the walking test: Eosinophils	Eosinophils will be measured in hundreds/µL	Day 0
Complete Blood Count in Controls before the walking test: Eosinophils	Eosinophils will be measured in hundreds/µL	Day 7
Complete Blood Count in Patients before the walking test: Eosinophils	Eosinophils will be measured in hundreds/µL	Day 0
Complete Blood Count in Patients before the walking test: Eosinophils	Eosinophils will be measured in hundreds/µL	Day 7
Complete Blood Count in Controls after the walking test: Eosinophils	Eosinophils will be measured in hundreds/µL	Day 0
Complete Blood Count in Controls after the walking test: Eosinophils	Eosinophils will be measured in hundreds/µL	Day 7
Complete Blood Count in Patients after the walking test: Eosinophils	Eosinophils will be measured in hundreds/µL	Day 0
Complete Blood Count in Patients after the walking test: Eosinophils	Eosinophils will be measured in hundreds/µL	Day 7
Complete Blood Count in Controls before the walking test: Basophils	Basophils will be measured in thousands/µL	Day 0
Complete Blood Count in Controls before the walking test: Basophils	Basophils will be measured in thousands/µL	Day 7
Complete Blood Count in Patients before the walking test: Basophils	Basophils will be measured in thousands/µL	Day 0
Complete Blood Count in Patients before the walking test: Basophils	Basophils will be measured in thousands/µL	Day 7
Complete Blood Count in Controls after the walking test: Basophils	Basophils will be measured in thousands/µL	Day 0
Complete Blood Count in Controls after the walking test: Basophils	Basophils will be measured in thousands/µL	Day 7
Complete Blood Count in Patients after the walking test: Basophils	Basophils will be measured in thousands/µL	Day 0
Complete Blood Count in Patients after the walking test: Basophils	Basophils will be measured in thousands/µL	Day 7
NETosis markers in Controls before the walking test	Fluorescence signal intensity of neutrophils will be measured on a SYSMEX automat	Day 0
NETosis markers in Controls after the walking test	Fluorescence signal intensity of neutrophils will be measured on a SYSMEX automat	Day 0
NETosis markers in Patients before the walking test	Fluorescence signal intensity of neutrophils will be measured on a SYSMEX automat	Day 7
NETosis markers in Patients after the walking test	Fluorescence signal intensity of neutrophils will be measured on a SYSMEX automat	Day 7
NETosis markers in Controls before the walking test: reacting monocytes	The percentage of reacting monocytes will be measured on a SYSMEX automat	Day 0
NETosis markers in Controls after the walking test: reacting monocytes	The percentage of reacting monocytes will be measured on a SYSMEX automat	Day 0
NETosis markers in Controls before the walking test: reacting monocytes	The percentage of reacting monocytes will be measured on a SYSMEX automat	Day 7
NETosis markers in Controls after the walking test: reacting monocytes	The percentage of reacting monocytes will be measured on a SYSMEX automat	Day 7
NETosis markers in Controls before the walking test: reacting lymphocytes	The percentage of reacting lymphocytes will be measured on a SYSMEX automat	Day 0
NETosis markers in Controls after the walking test: reacting lymphocytes	The percentage of reacting lymphocytes will be measured on a SYSMEX automat	Day 0
NETosis markers in Patients before the walking test: reacting lymphocytes	The percentage of reacting lymphocytes will be measured on a SYSMEX automat	Day 7
NETosis markers in Patients after the walking test: reacting lymphocytes	The percentage of reacting lymphocytes will be measured on a SYSMEX automat	Day 7
NETosis markers in Controls before the walking test:	The percentage of reacting lymphocytes will be measured on a SYSMEX automat	Day 0
NETosis markers in Controls after the walking test: circulating citrulinated histone H3	The percentage of circulating citrulinated histone H3 will be measured on a SYSMEX automat	Day 0
NETosis markers in Patients before the walking test: circulating citrulinated histone H3	The percentage of circulating citrulinated histone H3 will be measured on a SYSMEX automat	Day 7
NETosis markers in Patients after the walking test: circulating citrulinated histone H3	The percentage of circulating citrulinated histone H3 will be measured on a SYSMEX automat	Day 7
Coagulation factors in Controls before the walking test: fibrinogen	Fibrinogen will be measured in g/L	Day 0
Coagulation factors in Controls before the walking test	Coagulation factors XI, IX, VIII, VII, V, X and II will be measured in International Units	Day 0
Coagulation factors in Controls after the walking test: fibrinogen	Fibrinogen will be measured in g/L	Day 0
Coagulation factors in Controls after the walking test	Coagulation factors XI, IX, VIII, VII, V, X and II will be measured in International Units	Day 0
Coagulation factors in Patients before the walking test: fibrinogen	Fibrinogen will be measured in g/L	Day 7
Coagulation factors in Patients before the walking test	Coagulation factors XI, IX, VIII, VII, V, X and II will be measured in International Units	Day 7
Coagulation factors in Patients after the walking test: fibrinogen	Fibrinogen will be measured in g/L	Day 7
Coagulation factors in Patients after the walking test	Coagulation factors XI, IX, VIII, VII, V, X and II will be measured in International Units	Day 7
Indicators of fibrinoformation in Controls before the walking test: circulating fibrin monomers	Circulating fibrin monomers will be measured in fibrinogen equivalent units	Day 0
Indicators of fibrinoformation in Controls after the walking test: circulating fibrin monomers	Circulating fibrin monomers will be measured in fibrinogen equivalent units	Day 0
Indicators of fibrinoformation in Controls before the walking test: circulating fibrin monomers	Circulating fibrin monomers will be measured in fibrinogen equivalent units	Day 7
Indicators of fibrinoformation in Controls after the walking test: circulating fibrin monomers	Circulating fibrin monomers will be measured in fibrinogen equivalent units	Day 7
Indicators of fibrinoformation in Patients before the walking test: circulating fibrin monomers	Circulating fibrin monomers will be measured in fibrinogen equivalent units	Day 0
Indicators of fibrinoformation in Patients after the walking test: circulating fibrin monomers	Circulating fibrin monomers will be measured in fibrinogen equivalent units	Day 0
Indicators of fibrinoformation in Patients before the walking test: circulating fibrin monomers	Circulating fibrin monomers will be measured in fibrinogen equivalent units	Day 7
Indicators of fibrinoformation in Patients after the walking test: circulating fibrin monomers	Circulating fibrin monomers will be measured in fibrinogen equivalent units	Day 7
Indicators of fibrinoformation in Controls before the walking test: D-dimers	D-dimers will be measured in DDUs	Day 0
Indicators of fibrinoformation in Controls after the walking test: D-dimers	D-dimers will be measured in DDUs	Day 0
Indicators of fibrinoformation in Patients before the walking test: D-dimers	D-dimers will be measured in DDUs	Day 0
Indicators of fibrinoformation in Patients after the walking test: D-dimers	D-dimers will be measured in DDUs	Day 0
Indicators of fibrinoformation in Controls before the walking test: D-dimers	D-dimers will be measured in DDUs	Day 7
Indicators of fibrinoformation in Controls after the walking test: D-dimers	D-dimers will be measured in DDUs	Day 7
Indicators of fibrinoformation in Patients before the walking test: D-dimers	D-dimers will be measured in DDUs	Day 7
Indicators of fibrinoformation in Patients after the walking test: D-dimers	D-dimers will be measured in DDUs	Day 7
Markers of fibrinolysis in Controls before the walking test : Euglobulin lysis time	Euglobulin lysis time will be measured in hours	Day 0
Markers of fibrinolysis in Controls after the walking test : Euglobulin lysis time	Euglobulin lysis time will be measured in hours	Day 0
Markers of fibrinolysis in Patients before the walking test : Euglobulin lysis time	Euglobulin lysis time will be measured in hours	Day 0
Markers of fibrinolysis in Patients after the walking test : Euglobulin lysis time	Euglobulin lysis time will be measured in hours	Day 0
Markers of fibrinolysis in Controls before the walking test : Euglobulin lysis time	Euglobulin lysis time will be measured in hours	Day 7
Markers of fibrinolysis in Controls after the walking test : Euglobulin lysis time	Euglobulin lysis time will be measured in hours	Day 7
Markers of fibrinolysis in Patients before the walking test : Euglobulin lysis time	Euglobulin lysis time will be measured in hours	Day 7
Markers of fibrinolysis in Patients after the walking test : Euglobulin lysis time	Euglobulin lysis time will be measured in hours	Day 7
Markers of Endothelial function in Controls before the walking test: Willebrand factor	Willebrand factor will be measured as a %	Day 0
Markers of Endothelial function in Controls after the walking test: Willebrand factor	Willebrand factor will be measured as a %	Day 0
Markers of Endothelial function in Patients before the walking test: Willebrand factor	Willebrand factor will be measured as a %	Day 0
Markers of Endothelial function in Patients after the walking test: Willebrand factor	Willebrand factor will be measured as a %	Day 0
Markers of Endothelial function in Controls before the walking test: Willebrand factor	Willebrand factor will be measured as a %	Day 7
Markers of Endothelial function in Controls after the walking test: Willebrand factor	Willebrand factor will be measured as a %	Day 7
Markers of Endothelial function in Patients before the walking test: Willebrand factor	Willebrand factor will be measured as a %	Day 7
Markers of Endothelial function in Patients after the walking test: Willebrand factor	Willebrand factor will be measured as a%	Day 7
Markers of Endothelial function in Controls before the walking test: ristocetin cofactor	Ristocetin cofactor will be measured as a %	Day 0
Markers of Endothelial function in Controls after the walking test: ristocetin cofactor	Ristocetin cofactor will be measured as a %	Day 0
Markers of Endothelial function in Patients before the walking test: ristocetin cofactor	Ristocetin cofactor will be measured as a %	Day 0
Markers of Endothelial function in Patients after the walking test: ristocetin cofactor	Ristocetin cofactor will be measured as a %	Day 0
Markers of Endothelial function in Controls before the walking test: ristocetin cofactor	Ristocetin cofactor will be measured as a %	Day 7
Markers of Endothelial function in Controls after the walking test: ristocetin cofactor	Ristocetin cofactor will be measured as a %	Day 7
Markers of Endothelial function in Patients before the walking test: ristocetin cofactor	Ristocetin cofactor will be measured as a %	Day 7
Markers of Endothelial function in Patients after the walking test: ristocetin cofactor	Ristocetin cofactor will be measured as a %	Day 7
Markers of Endothelial function in Controls before the walking test: ADAMTS-13 activity	ADAMTS-13 activity will be measured as a %	Day 0
Markers of Endothelial function in Controls after the walking test: ADAMTS-13 activity	ADAMTS-13 activity will be measured as a %	Day 0
Markers of Endothelial function in Patients before the walking test: ADAMTS-13 activity	ADAMTS-13 activity will be measured as a %	Day 0
Markers of Endothelial function in Patients after the walking test: ADAMTS-13 activity	ADAMTS-13 activity will be measured as a %	Day 0
Markers of Endothelial function in Controls before the walking test: ADAMTS-13 activity	ADAMTS-13 activity will be measured as a %	Day 7
Markers of Endothelial function in Controls after the walking test: ADAMTS-13 activity	ADAMTS-13 activity will be measured as a %	Day 7
Markers of Endothelial function in Patients before the walking test: ADAMTS-13 activity	ADAMTS-13 activity will be measured as a %	Day 7
Markers of Endothelial function in Patients after the walking test: ADAMTS-13 activity	ADAMTS-13 activity will be measured as a %	Day 7
Markers of Endothelial function in Controls before the walking test: soluble thrombomodulin	Soluble thrombomodulin will be measured as a %	Day 0
Markers of Endothelial function in Controls after the walking test: soluble thrombomodulin	Soluble thrombomodulin will be measured as a %	Day 0
Markers of Endothelial function in Patients before the walking test: soluble thrombomodulin	Soluble thrombomodulin will be measured as a %	Day 0
Markers of Endothelial function in Patients after the walking test: soluble thrombomodulin	Soluble thrombomodulin will be measured as a %	Day 0
Markers of Endothelial function in Controls before the walking test: soluble thrombomodulin	Soluble thrombomodulin will be measured as a %	Day 7
Markers of Endothelial function in Controls after the walking test: soluble thrombomodulin	Soluble thrombomodulin will be measured as a %	Day 7
Markers of Endothelial function in Patients before the walking test: soluble thrombomodulin	Soluble thrombomodulin will be measured as a %	Day 7
Markers of Endothelial function in Patients after the walking test: soluble thrombomodulin	Soluble thrombomodulin will be measured as a %	Day 7
Markers of Endothelial function in Controls before the walking test: soluble endothelial protein C receptor	Soluble endothelial protein C receptor will be measured as a %	Day 0
Markers of Endothelial function in Controls after the walking test: soluble endothelial protein C receptor	Soluble endothelial protein C receptor will be measured as a %	Day 0
Markers of Endothelial function in Patients before the walking test: soluble endothelial protein C receptor	Soluble endothelial protein C receptor will be measured as a %	Day 0
Markers of Endothelial function in Patients after the walking test: soluble endothelial protein C receptor	Soluble endothelial protein C receptor will be measured as a %	Day 0
Markers of Endothelial function in Controls before the walking test: soluble endothelial protein C receptor	Soluble endothelial protein C receptor will be measured as a %	Day 7
Markers of Endothelial function in Controls after the walking test: soluble endothelial protein C receptor	Soluble endothelial protein C receptor will be measured as a %	Day 7
Markers of Endothelial function in Patients before the walking test: soluble endothelial protein C receptor	Soluble thrombomodulin will be measured as a %	Day 7
Markers of Endothelial function in Patients after the walking test: soluble endothelial protein C receptor	Soluble thrombomodulin will be measured as a %	Day 7

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age in Controls	Ages will be recorded in years	Day 0
Sex in Controls	Sex will be recorded as Male/Female/Non-binary	Day 0
Body mass index in Controls	Body mass index of controls will be recorded in units of kg/m²	Day 0
Age in Patients	Ages will be recorded in years	Day 0
Sex in Patients	Sex will be recorded as Male/Female/Non-binary	Day 0
Body Mass Index in Patients	Body mass index of controls will be recorded in units of kg/m²	Day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Antonia PEREZ MARTIN, Prof., Nimes University Hospital; Principal Investigator: Stéphane FAURE, Nimes University Hospital

Publications and helpful links

General Publications

• Gris JC, Guillotin F, Dos Santos TP, Chea M, Loubet P, Laureillard D, Sotto A, Muller L, Barbar SD, Roger C, Lefrant JY, Jung B, Klouche K, Mura T, Quere I, Perez-Martin A. Prognostic value of an automated thrombin generation assay in COVID-19 patients entering hospital: A multicentric, prospective observational study. Thromb Res. 2023 Feb;222:85-95. doi: 10.1016/j.thromres.2022.12.019. Epub 2023 Jan 2.

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: April 28, 2024
• First Submitted That Met QC Criteria: May 13, 2024
• First Posted (Actual): May 17, 2024

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Physical exercise
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism
• Other Study ID Numbers: NIMAO 2023 1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No