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Epidemiology of Incidents and Accidents in Sport. Influence of Moisture.

Primary Purpose

Fractures, Sprain, Stress Fractures

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
eau minérale d'Aix-Les-Bains
tap water
Sponsored by
Centre de Recherche Rhumatologique et Thermal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fractures focused on measuring Drinking Water, Mineral water, Sports, Accident prevention

Eligibility Criteria

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

Inclusion Criteria:

  • Sports practitioners aged 12 to 80 years;
  • Enrolled in one of two clubs participating in the study

Exclusion Criteria:

  • Pregnant or breastfeeding.
  • Major Licensee protected by law or deprived of liberty by administrative and judicial decisions;
  • Licensee with an contra-indication for drinking water of Aix (anuric renal failure for example)
  • Having dismissed contra-indication for sport practice (unlikely event, regulation of clubs requiring a medical certificate)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Mineral Water

    Tap Water

    Arm Description

    mineral water

    usual water intake

    Outcomes

    Primary Outcome Measures

    number of incidents and accidents in sport practice

    Secondary Outcome Measures

    estimated level of physical activity
    Warm-up time
    weigh

    Full Information

    First Posted
    January 21, 2015
    Last Updated
    February 8, 2015
    Sponsor
    Centre de Recherche Rhumatologique et Thermal
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02346786
    Brief Title
    Epidemiology of Incidents and Accidents in Sport. Influence of Moisture.
    Official Title
    Epidemiology of Incidents and Accidents in Sport. Influence of Moisture.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2015 (undefined)
    Primary Completion Date
    November 2015 (Anticipated)
    Study Completion Date
    May 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Centre de Recherche Rhumatologique et Thermal

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    sports accidents and incidents are relatively frequent. We hypothesize that the pursuit of good hydration, including days without training or competition could prevent their occurrence
    Detailed Description
    Main objective: to show, among practicing sports club that regular hydration, including days without competition may prevent the occurrence of an incident or accident during sport. Primary endpoint: number of accidents and sport incidents, - Adverse events and complications at 3 months and 6 months. EXPERIMENTAL PLAN: randomized clinical trial of two groups of athletes: dismissed the first group consume water from Aix-les-Bains in quantity defined during the 6 months of the study. Licensees 2nd group (control group) will have a free hydration, at their convenience and habits during the 6 months of the study. They will be able, if they wish to receive water from Aix within 3 months of the study. NATURE OF TREATMENT: daily intake of Aix 1.5l water baths according to European recommendations (1 liter for children under 16 years) POPULATION STUDIED Features licensees: Licensee aged 10 to 80 years; Practitioners sport regularly at a health club Number of members: as this is a pilot study will enroll a maximum of volunteers in each of the two clubs, a staff of 50 athletes per group is expected. STATISTICAL ANALYSIS The variables are described (number and frequency for categorical variables, mean, standard deviation, median and confidence interval for continuous quantitative variables). The initial comparability of the two groups will be tested. The primary endpoint will be analyzed using a Chi-square test without continuity correction if the validity conditions are true or if otherwise by Fisher's exact test. The usual additional criteria (relative risk and 95) will be presented. For the analysis of quantitative secondary endpoints, the Student t-test will be used. If distribution does not meet the normal distribution, the nonparametric Mann-Whitney will be used. The percentage change in the activity score between baseline and 6 months 3 months will be calculated. The qualitative evaluation criteria will be analyzed by Chi-square test without continuity correction if the conditions of validity is checked or if otherwise by Fisher's exact test. An analysis of variance with repeated measures (comparison Inclusion- 3 months - 6 months) will be made on the physical activity score taking into account the treatment factor and interaction repetitions X treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fractures, Sprain, Stress Fractures, Aches, Tendinitis
    Keywords
    Drinking Water, Mineral water, Sports, Accident prevention

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Mineral Water
    Arm Type
    Experimental
    Arm Description
    mineral water
    Arm Title
    Tap Water
    Arm Type
    Active Comparator
    Arm Description
    usual water intake
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    eau minérale d'Aix-Les-Bains
    Intervention Description
    Sodium 0.44 mg Magnésium 2.25 mg Phosphore 0.003 mg Potassium 0.08 mg Calcium 8.23 mg Manganèse 0.0001 mg Fer 0.001 mg Cuivre 0.0005 mg Zinc 0.0005 mg Sélénium 1 µg Iode 0 µg
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    tap water
    Primary Outcome Measure Information:
    Title
    number of incidents and accidents in sport practice
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    estimated level of physical activity
    Time Frame
    6 month
    Title
    Warm-up time
    Time Frame
    6 months
    Title
    weigh
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Sports practitioners aged 12 to 80 years; Enrolled in one of two clubs participating in the study Exclusion Criteria: Pregnant or breastfeeding. Major Licensee protected by law or deprived of liberty by administrative and judicial decisions; Licensee with an contra-indication for drinking water of Aix (anuric renal failure for example) Having dismissed contra-indication for sport practice (unlikely event, regulation of clubs requiring a medical certificate)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Romain J FORESTIER, MD
    Phone
    0479351487
    Email
    romain.forestier@wanadoo.fr

    12. IPD Sharing Statement

    Learn more about this trial

    Epidemiology of Incidents and Accidents in Sport. Influence of Moisture.

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