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临床试验/NCT02846051
NCT02846051已完成不适用

Effect of Intensive Sports Practice on Lower Limb Varicose Veins

University of Franche-Comté2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2015年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
240
试验地点
2
主要终点
varicose veins (C2 of the CEAP classification)

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

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

干预措施: 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

干预措施: venous mapping (Procedure)

结局指标

主要结局

varicose veins (C2 of the CEAP classification)

时间窗: 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.)

次要结局

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

研究者

发起方
University of Franche-Comté
申办方类型
Other
责任方
Principal Investigator
主要研究者

Laurent Mourot

MCU-HDR

University of Franche-Comté

研究点 (2)

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