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
About this trial
This is an interventional prevention trial for Fractures focused on measuring Drinking Water, Mineral water, Sports, Accident prevention
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)
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
NCT ID
NCT02346786
First Posted
January 21, 2015
Last Updated
February 8, 2015
Sponsor
Centre de Recherche Rhumatologique et Thermal
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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