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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02346786
• Other study ID #: CRRhumatologique
• Status: Not yet recruiting
• Phase: Phase 3
• First received: January 21, 2015
• Last updated: February 8, 2015
• Start date: April 2015
• Est. completion date: May 2016

Study information

• Verified date: February 2015
• Source: Centre de Recherche Rhumatologique et Thermal
• Contact: Romain J FORESTIER, MD
• Phone: 0479351487
• Email: romain.forestier[@]wanadoo.fr
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 80 Years

Eligibility

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 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

Intervention

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
• tap water

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre de Recherche Rhumatologique et Thermal

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of incidents and accidents in sport practice		6 months	Yes
Secondary	estimated level of physical activity		6 month	No
Secondary	Warm-up time		6 months	No
Secondary	weigh		6 months	No