Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-01-10 @ 4:13 PM
Study NCT ID:
NCT02846051
Status:
COMPLETED
Last Update Posted:
2019-04-18
First Post:
2016-07-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Intensive Sports Practice on Lower Limb Varicose Veins
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014648', 'term': 'Varicose Veins'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-16', 'studyFirstSubmitDate': '2016-07-15', 'studyFirstSubmitQcDate': '2016-07-26', 'lastUpdatePostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'varicose veins (C2 of the CEAP classification)', 'timeFrame': '3 years', 'description': 'varicose vein definition : subcutaneous vein with a diameter greater than 3 mm while standing, usually winding, the seat of pathological reflux. Varicose veins may interest saphenous trunks, their tributaries and non saphenous network.\n\nDuplex Ultrasound Investigation of the Veins in Chronic Venous Disease of the Lower Limbs-UIP Consensus\n\nChronic venous disorders Assessment Score (Carpentier PH, Poulain C, Fabry R, Chleir F, Guias B, Bettarel-Binon C. Ascribing leg symptoms to chronic venous disorders: the construction of a diagnostic score. J Vasc Surg Off Publ Soc Vasc Surg Int Soc Cardiovasc Surg North Am Chapter. nov 2007;46(5):991- 6.)'}], 'secondaryOutcomes': [{'measure': 'lower limb vein calibers', 'timeFrame': '3 years', 'description': 'echo doppler measurement of the antero posterior vein caliber'}, {'measure': 'venous reflux', 'timeFrame': '3 years', 'description': 'echo doppler Search venous reflux'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['varicose vein', 'physical activity'], 'conditions': ['Varicose Vein']}, 'descriptionModule': {'briefSummary': 'Compare the frequency of varicose veins in the lower limbs in a population exposed to intensive sport compared to individuals matched by sex, age and body mass index (BMI) did not have an intensive sport.', 'detailedDescription': 'Chronic venous disease is a very common disease in industrialized countries. The prevalence of this disease is estimated in France 30.1% in men and 50.5% women.\n\nSufferers report pain, heaviness and itching of the lower limbs, and these symptoms are increased at night and in a warm environment. Clinically chronic venous disease resulting in varicose veins (veins visible under the skin, tortuous and dilated), edema (swelling predominant at the ankles) and in the later stages include skin damage of up \'to the ulcer.\n\nThe pathological mechanisms underlying chronic venous disease are mainly related to incontinence of the valves of the veins of the lower limbs. The initial role of these valves is to allow the return of blood to the heart and prevent it falls constantly in the legs. A breach of these valves therefore will result in an alteration of venous return and dilatation of the affected veins. It will be highlighted by a venous reflux when analyzing Doppler.\n\nA number of parameters have been identified as factors favoring chronic venous disease in the lower limbs. Thus heredity (family history of venous disease), age, number of pregnancies among women, a history of phlebitis, overweight and physical inactivity increase the risk of chronic venous disease.\n\nThe effects of physical activity:\n\nThe practice of physical activity helps fight against physical inactivity. It is recognized as a protective factor against chronic venous disease. That is why the French and international companies of medicine and vascular surgery have incorporated in their recommendations to patients the practice of moderate physical activity and regular part of the prevention and treatment of chronic venous disease.\n\nMoreover, the impact of intensive practice of a sport (versus "moderate and regular physical activity") of chronic venous disease is not known. Assumptions were issued from the nineteenth century on the possible risk of fostering the emergence of chronic venous disease at an excessive sports. Thus, from the 1820s Dr. Rima Thomas, surgeon of Napoleon\'s army, stated: "inertia as much as excessive activity come together to produce the same effect, the varicose vein." This idea is still relevant, in fact some experts recommend, at this time, intensive sports wear compression devices in the lower limbs during sports practice to prevent this phenomenon. However, no study has established a link between intensive practice of sport and venous condition of the legs.\n\nThe purpose of the study:\n\nVARISPORT The study will aim to analyze the condition of the veins of the lower limbs in two groups of voluntary individuals, aged 18 to 80 years, in the same population:\n\n* An "intensive sport practice": This group will consist of men and women who practice for more than 6 months, a drive of at least 8 hours / week, intense, above the ventilatory threshold, or 60-70 % maximum oxygen consumption or 70- 80% of maximum heart rate, ie beyond a moderate slowdown. If stopping the intensive sport practice, the duration of the stop at the time of the study should be less practice time.\n* A "control" group: the subjects included in this group will have profiles that approximate subjects of the group "intensive practice sports", same sex, same age, BMI close; but the practice of a sport is less than 8 hours per week.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Volunteers\n* From 18 to 80 years\n* Free to consent\n* Covered by social security\n* Reported in the national register of healthy volunteers\n\nExclusion Criteria:\n\n* Signed Refusal of the consent form .\n* Refusal to be registered with the National File Healthy Volunteers.\n* People exclusion period from another study\n* Under guardianship\n* Inability of the subject to hold long enough in standing position (20 minutes) for practicing phlebology examination.'}, 'identificationModule': {'nctId': 'NCT02846051', 'acronym': 'VARISPORT', 'briefTitle': 'Effect of Intensive Sports Practice on Lower Limb Varicose Veins', 'organization': {'class': 'OTHER', 'fullName': 'University of Franche-Comté'}, 'officialTitle': 'Effect of Intensive Sports Practice on Lower Limb Varicose Veins', 'orgStudyIdInfo': {'id': 'EPSI_VARISPORT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'intensive sport practice', 'description': 'intensive sport practice\n\n1. the subject must practice for more than six months a drive of at least 8 hours / week, intense, above the ventilatory threshold, or 60-70% of maximum consumption oxygen or 70-80% of maximum heart rate, ie beyond a moderate slowdown. If stopping the intensive sport practice, the duration of the stop at the time of the study should be less practice time.\n2. volunteers,\n3. from 18 to 80 years,\n4. free to consent.\n5. covered by social security.\n6. reported in the national register of healthy volunteers.\n\nThe intervention is a lower limb venous examination = venous mapping', 'interventionNames': ['Procedure: venous mapping']}, {'type': 'OTHER', 'label': 'control group', 'description': '\\&) Volunteers who do not have intensive sport practice as it is defined in the group "intensive sport practice" 2) from 18 to 80 years, 3) free to consent. 4) covered by social security. 5) reported in the national register of healthy volunteers.\n\nThe intervention is a lower limb venous examination = venous mapping', 'interventionNames': ['Procedure: venous mapping']}], 'interventions': [{'name': 'venous mapping', 'type': 'PROCEDURE', 'description': 'clinical examination + doppler echo', 'armGroupLabels': ['control group', 'intensive sport practice']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Besançon', 'country': 'France', 'facility': 'Beliard', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}], 'overallOfficials': [{'name': 'Nicolas Tordi, PU', 'role': 'STUDY_DIRECTOR', 'affiliation': "Equipe d'Accueil 4267 : Fonctions et dysfonctions épithéliales Université de Franche Comté"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'If a venous pathology is detected during this study, the data are passed on to the doctor of the subject'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Franche-Comté', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MCU-HDR', 'investigatorFullName': 'Laurent Mourot', 'investigatorAffiliation': 'University of Franche-Comté'}}}}