Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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:
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mineral Water | Experimental | mineral water |
|
| Tap Water | Active Comparator | usual water intake |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eau minérale d'Aix-Les-Bains | Dietary Supplement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| number of incidents and accidents in sport practice | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| estimated level of physical activity | 6 month | |
| Warm-up time | 6 months | |
| weigh |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Romain J FORESTIER, MD | Contact | 0479351487 | romain.forestier@wanadoo.fr |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D013180 | Sprains and Strains |
| D015775 | Fractures, Stress |
| D010146 | Pain |
| D052256 | Tendinopathy |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| tap water | Dietary Supplement |
|
| 6 months |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D013708 | Tendon Injuries |