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

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

Study Overview

• Status: Unknown
• Conditions: Sprain; Fractures; Tendinitis; Aches; Stress Fractures
• Intervention / Treatment: Dietary supplement: eau minérale d'Aix-Les-Bains; Dietary supplement: tap water

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 3

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mineral Water; mineral water	Dietary supplement: eau minérale d'Aix-Les-Bains; 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
Active Comparator: Tap Water; usual water intake	Dietary supplement: tap water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
number of incidents and accidents in sport practice	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
estimated level of physical activity	6 month
Warm-up time	6 months
weigh	6 months

Collaborators and Investigators

• Sponsor: Centre de Recherche Rhumatologique et Thermal

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): November 1, 2015
• Study Completion (Anticipated): May 1, 2016

Study Registration Dates

• First Submitted: January 21, 2015
• First Submitted That Met QC Criteria: January 26, 2015
• First Posted (Estimate): January 27, 2015

Study Record Updates

• Last Update Posted (Estimate): February 10, 2015
• Last Update Submitted That Met QC Criteria: February 8, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Accident prevention; Sports; Drinking Water; Mineral water
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Fractures, Bone; Fractures, Stress
• Other Study ID Numbers: CRRhumatologique