Variations in the Hemostatic System Induced by a Standardized Walking Test

Sponsor
Centre Hospitalier Universitaire de Nīmes
Study ID
NCT06418633
Status
Recruiting
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Conditions

  • Venous Thromboembolism

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • 60-minute walking test — OTHER
    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 — DIAGNOSTIC_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 — DIAGNOSTIC_TEST
    33.3 ml of blood will be taken from each participant immediately after undergoing the 60-minute walking test.
  • Electrocardiogram — OTHER
    An electrocardiogram will be carried out throughout the exercise period and during the first 30 minutes of recovery.
  • Blood pressure monitoring — OTHER
    Blood pressure will be monitored out throughout the exercise period and during the first 30 minutes of recovery.

Study Details

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.

Key Dates

First listed
May 17, 2024
Start date
Feb 11, 2025
Status verified
Jun 2026
Primary completion
Apr 1, 2030
Completion
Apr 1, 2030

Study Design

Enrollment
94 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Control group
    Subjects with neither a personal history nor family history of venous thromboembolism in first-degree relatives.
  • 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
  • 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.
  • 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.

Primary Outcome Measure

Thrombin generation dosage before effort in controls [ Time Frame: Day 0 ]

Central Contacts

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