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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02346786
Other study ID # CRRhumatologique
Secondary ID
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


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
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