FracturesPhase 3NCT02346786
Epidemiology of Incidents and Accidents in Sport. Influence of Moisture.
A Phase 3 study testing eau minérale d'Aix-Les-Bains and tap water in people with Fractures and Sprain, run by Centre de Recherche Rhumatologique et Thermal.
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 Read more about this study
- Who is it for?
- Ages 10 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Fractures, Sprain, Stress Fractures
- What is being tested?
- eau minérale d'Aix-Les-Bains and tap water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to May 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Sports practitioners aged 12 to 80 years;
- Enrolled in one of two clubs participating in the study
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet.
About this study
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
Read the 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.
- Conditions
- Fractures, Sprain, Stress Fractures, Aches, Tendinitis
- Being tested
- eau minérale d'Aix-Les-Bains, tap water
- Keywords
- Drinking Water, Mineral water, Sports, Accident prevention
- Medical subject headings
- Fractures, Bone, Sprains and Strains, Fractures, Stress, Pain, Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eau minérale d'Aix-Les-BainsDietary 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
tap waterDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Mineral Water | Experimental | mineral water Receives: Dietary Supplement: eau minérale d'Aix-Les-Bains |
| Tap Water | Active comparator | usual water intake Receives: Dietary Supplement: tap water |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of incidents and accidents in sport practice
Measured: 6 months
Secondary outcomes (3)
estimated level of physical activity
Measured: 6 month
Warm-up time
Measured: 6 months
weigh
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startApr 2015
- Primary completionNov 2015 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche Rhumatologique et Thermal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FORESTIER Romain, Centre de Recherche Rhumatologique et Thermal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02346786
- Sponsor's protocol ID
- CRRhumatologique
- Status last verified
- Feb 2015
- First submitted
- 21 Jan 2015
- Last updated
- 10 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Incidents and Accidents in Sport. Influence of Moisture.
- ClinicalTrials.gov ID
- NCT02346786
- Acronym / sponsor ID
- CRRhumatologique
- Conditions
- Fractures, Sprain, Stress Fractures, Aches, Tendinitis
- Keywords
- Drinking Water, Mineral water, Sports, Accident prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre de Recherche Rhumatologique et ThermalUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Nov 2015 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 27 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mineral Water | Experimental | Dietary Supplement: eau minérale d'Aix-Les-Bainsmineral water |
| Tap Water | Active comparator | Dietary Supplement: tap waterusual water intake |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Sports practitioners aged 12 to 80 years;
- Enrolled in one of two clubs participating in the study
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eau minérale d'Aix-Les-BainsSodium 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 | Dietary supplement | Mineral Water |
| tap water | Dietary supplement | Tap Water |
Primary outcome
number of incidents and accidents in sport practice
Time frame: 6 months
3 secondary outcomes
estimated level of physical activity
Time frame: 6 month
Warm-up time
Time frame: 6 months
weigh
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing eau minérale d'Aix-Les-Bains and tap water in people with Fractures and Sprain, run by Centre de Recherche Rhumatologique et Thermal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Romain J FORESTIER, MD (0479351487, romain.forestier@wanadoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of incidents and accidents in sport practice (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2015.