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

Fractures Clinical Trial

Official title: Epidemiology of Incidents and Accidents in Sport. Influence of Moisture.

Status Not yet recruiting

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aches
• Fractures
• Fractures, Bone
• Fractures, Stress
• Sprain
• Stress Fractures
• Tendinitis

• NCT number: NCT02346786
• Study type: Interventional
• Source: Centre de Recherche Rhumatologique et Thermal
• Contact: Romain J FORESTIER, MD
• Phone: 0479351487
• Email: romain.forestier@wanadoo.fr
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: April 2015
• Completion date: May 2016