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Trial: NCT02846051 [RDF]

Label NCT02846051
Slug nct02846051
Trialid NCT02846051
Lookup name NCT02846051
Lastchanged date July 28, 2016
Firstreceived results date
Firstreceived date July 15, 2016
Id info nct id NCT02846051
Overall status Recruiting
Id info secondary id
Biospec retention
Required header link text Link to the current record.
Enrollment 240
Number of arms 2
Is section 801
Is fda regulated No
Brief title Effect of Intensive Sports Practice on Lower Limb Varicose Veins
Official title Effect of Intensive Sports Practice on Lower Limb Varicose Veins
Study type Interventional
Id info nct alias
Completion date October 2018
Verification date July 2016
Why stopped
Id info org study id EPSI_VARISPORT
Required header url
Study design Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
Source University of Franche-Comté
Primary completion date July 2016
Brief summary
Number of groups
Required header download date processed this data on September 06, 2016
Phase N/A
Start date October 2015
Has expanded access No
Biospec descr
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.
Condition browse 67695683c216ad930b74deed8a13125f
Intervention browse None
Responsible party 015b495dfd0be1a85fcb46d41f363abd
Overall contact Samuel Béliard, MD (Contact)
Overall contact backup None
Sponsor group db5e5c37420fab20b732c918e5b8f500
Oversight info France: Institutional Ethical Committee (Oversight_info)
Eligibility 93bfe9ab7835eba34ad80914300b482d
Keywords physical activity, varicose vein
Conditions Varicose Vein
Locations 7738ba5e8250d106d4ecab19d9a699ea
Links None
Results references None
Arm groups control group (Arm Group), intensive sport practice (Arm Group)
Location countries France
Interventions venous mapping (Intervention)
Secondary outcomes 62e638d08007b348254bf8cc86780cab, 6aa860cb1fa5057060f8dd1e3f8f5789
References None
Primary outcomes b3311b50c02b41d755ddf1557ea10b92
Removed countries None
Overall officials cdb19ccd7ab29d0cb62972c80ee022f4