Skip to main content
Clinical Trials/NCT02846051
NCT02846051CompletedNot Applicable

Effect of Intensive Sports Practice on Lower Limb Varicose Veins

University of Franche-Comté2 sites in 1 country240 target enrollmentStarted: October 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
240
Locations
2
Primary Endpoint
varicose veins (C2 of the CEAP classification)

Study Overview

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:

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

intensive sport practice

Other

intensive sport practice

  1. 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.
  2. volunteers,
  3. from 18 to 80 years,
  4. free to consent.
  5. covered by social security.
  6. reported in the national register of healthy volunteers.

The intervention is a lower limb venous examination = venous mapping

Intervention: venous mapping (Procedure)

control group

Other

&) 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: venous mapping (Procedure)

Outcomes

Primary Outcomes

varicose veins (C2 of the CEAP classification)

Time Frame: 3 years

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 Outcomes

  • lower limb vein calibers(3 years)
  • venous reflux(3 years)

Investigators

Sponsor
University of Franche-Comté
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Laurent Mourot

MCU-HDR

University of Franche-Comté

Study Sites (2)

Loading locations...

Similar Trials

Effect of Intensive Sports Practice on... | Clinical Trial