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Varicose VeinVARISPORTNCT02846051

Effect of Intensive Sports Practice on Lower Limb Varicose Veins

A study testing venous mapping in people with Varicose Vein, run by University of Franche-Comté at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Varicose Vein
What is being tested?
venous mapping
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteFrance
Study dates
Oct 2015to Apr 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

France1 site
  • Beliard

    Besançon, 25000

Other trials in France

About this study

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.

Read the 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.
Conditions
Varicose Vein
Being tested
venous mapping
Keywords
varicose vein, physical activity
Medical subject headings
Varicose Veins, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • venous mappingProcedure or surgery

    clinical examination + doppler echo

Study groups in NCT02846051
Study groupRoleWhat they receive
intensive sport practiceOtherintensive 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
Receives: Procedure: venous mapping
control groupOther\&) 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
Receives: Procedure: venous mapping

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.)

    Measured: 3 years

Secondary outcomes (2)
  1. lower limb vein calibers

    echo doppler measurement of the antero posterior vein caliber

    Measured: 3 years

  2. venous reflux

    echo doppler Search venous reflux

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2016 (estimated)
  2. Study startOct 2015
  3. Primary completionApr 2019
  4. Study completionApr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02846051
Sponsor's protocol ID
EPSI_VARISPORT
Acronym
VARISPORT
Status last verified
Apr 2019
First submitted
15 Jul 2016
Last updated
18 Apr 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: If a venous pathology is detected during this study, the data are passed on to the doctor of the subject

Questions about this trial

What is this clinical trial studying?

A study testing venous mapping in people with Varicose Vein, run by University of Franche-Comté at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

varicose veins (C2 of the CEAP classification) (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.

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