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Effect of Intensive Sports Practice on Lower Limb Varicose Veins (VARISPORT)

Primary Purpose

Varicose Vein

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
venous mapping
Sponsored by
University of Franche-Comté
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Varicose Vein focused on measuring varicose vein, physical activity

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Volunteers
  • From 18 to 80 years
  • Free to consent
  • Covered by social security
  • Reported in the national register of healthy volunteers

Exclusion Criteria:

  • Signed Refusal of the consent form .
  • Refusal to be registered with the National File Healthy Volunteers.
  • People exclusion period from another study
  • Under guardianship
  • Inability of the subject to hold long enough in standing position (20 minutes) for practicing phlebology examination.

Sites / Locations

  • Beliard

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

intensive sport practice

control group

Arm Description

intensive sport practice 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. volunteers, from 18 to 80 years, free to consent. covered by social security. reported in the national register of healthy volunteers. The intervention is a lower limb venous examination = venous mapping

&) 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. The intervention is a lower limb venous examination = venous mapping

Outcomes

Primary Outcome Measures

varicose veins (C2 of the CEAP classification)
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. Duplex Ultrasound Investigation of the Veins in Chronic Venous Disease of the Lower Limbs-UIP Consensus Chronic 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.)

Secondary Outcome Measures

lower limb vein calibers
echo doppler measurement of the antero posterior vein caliber
venous reflux
echo doppler Search venous reflux

Full Information

First Posted
July 15, 2016
Last Updated
April 16, 2019
Sponsor
University of Franche-Comté
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1. Study Identification

Unique Protocol Identification Number
NCT02846051
Brief Title
Effect of Intensive Sports Practice on Lower Limb Varicose Veins
Acronym
VARISPORT
Official Title
Effect of Intensive Sports Practice on Lower Limb Varicose Veins
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
April 2019 (Actual)
Study Completion Date
April 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Franche-Comté

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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. Sufferers 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. The 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. A 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. The effects of physical activity: The 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. Moreover, 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. The purpose of the study: VARISPORT 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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Vein
Keywords
varicose vein, physical activity

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intensive sport practice
Arm Type
Other
Arm Description
intensive sport practice 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. volunteers, from 18 to 80 years, free to consent. covered by social security. reported in the national register of healthy volunteers. The intervention is a lower limb venous examination = venous mapping
Arm Title
control group
Arm Type
Other
Arm 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. The intervention is a lower limb venous examination = venous mapping
Intervention Type
Procedure
Intervention Name(s)
venous mapping
Intervention Description
clinical examination + doppler echo
Primary Outcome Measure Information:
Title
varicose veins (C2 of the CEAP classification)
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. Duplex Ultrasound Investigation of the Veins in Chronic Venous Disease of the Lower Limbs-UIP Consensus Chronic 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.)
Time Frame
3 years
Secondary Outcome Measure Information:
Title
lower limb vein calibers
Description
echo doppler measurement of the antero posterior vein caliber
Time Frame
3 years
Title
venous reflux
Description
echo doppler Search venous reflux
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Volunteers From 18 to 80 years Free to consent Covered by social security Reported in the national register of healthy volunteers Exclusion Criteria: Signed Refusal of the consent form . Refusal to be registered with the National File Healthy Volunteers. People exclusion period from another study Under guardianship Inability of the subject to hold long enough in standing position (20 minutes) for practicing phlebology examination.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Tordi, PU
Organizational Affiliation
Equipe d'Accueil 4267 : Fonctions et dysfonctions épithéliales Université de Franche Comté
Official's Role
Study Director
Facility Information:
Facility Name
Beliard
City
Besancon
ZIP/Postal Code
25000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
If a venous pathology is detected during this study, the data are passed on to the doctor of the subject

Learn more about this trial

Effect of Intensive Sports Practice on Lower Limb Varicose Veins

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