- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04078256
The Importance of Exercise to Prevent Injuries in Athletes
EFFECTIVENESS OF A PROPRIOCEPTIVE EXERCISE PROGRAM IN THE PREVENTION OF INJURIES IN RECREATIONAL RUNNERS
Introduction: running is one of the most accessible and practiced sports in the world since the 21st century. Unfortunately, the incidence of injuries in the population that practices it is high regardless of experience, although the risk of injury increases in amateur runners. One of the main keys to reduce the incidence of running related injuries may be to improve the ability to reduce the load or impact. For this, there are different strategies such as a gradual increase in the load to run, and exercise within which is muscle strengthening and balance training or proprioception.
Objective: to verify the effectiveness of a program of proprioceptive exercises based on the static and dynamic balance for the reduction of lower limb injuries in amateur runners during the competition season.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Methodology: 66 amateur runners, after simple size calculation, will be randomized into two groups. Experimental group will carry out the proprioceptive exercise program during 8 weeks at the begining of the season and control group will continue with their usual training routine. The main variable running related injury will be collected weekly during the follow-up.
Results: When all the data needed for the study has been collected, researchers gathers results and exports them for statistical interpretation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Madrid
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Alcala de Henares, Madrid, Spain, 28871
- Grupo Fisioterapia y Dolor
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Weekly training of at least 15 kilometers.
- At least practice running 6 months for 1-3 times a week.
Exclusion Criteria:
- To have some type of lower limb or lower back injury at present or in the last 6 months.
- Having undergone surgery for any back or lower limb injury.
- Pregnant.
- Neural dysfunction / disability.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
Group will carry out the proprioceptive exercise program during 8 weeks at the begining of the season
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Group A will carry out two sessions of proprioceptive training per week, in a total of 8 weeks, during the pre-season period (September-October).
Each session will last approximately 30 minutes and will include 6 exercises.
The execution of the exercises will be supervised by a physiotherapist and a national trainer of athletics.
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Placebo Comparator: Control group
Control group will continue with their usual training routine
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The subjects of the control group (group B) will be informed so that they do not include any change in their usual training routine.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knee Joint Position Sense (JPS)
Time Frame: Change from Baseline Joint Position Sense Pressure at 8 weeks
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JPSThe JPS is defined as the awareness of the actual position of the limb to quantify proprioception.The method for measuring JPS is to place the joint at a specific target angle and then, after the limb has been moved back to the starting angle, the subject is asked to actively or passively reproduce the target angle.
The outcome of the measurement is the absolute error (AE), which is the difference between the true target angle and the reproduced angle
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Change from Baseline Joint Position Sense Pressure at 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Y Balance Test (YBT)
Time Frame: Change from Baseline dynamic balance at 8 weeks
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The YBT, derived from the Star Excursion Balance Test (SEBT), has been reported to be a valid and reliable measure of dynamic balance; furthermore, the results of the YBT have been reported to be related to lower-extremity impairments and to be predictors of injuries.The YBT instrument has a central raised platform with three pieces of PVC (polyvinyl chloride) pipe in the three directions with a sliding plastic reach indicator that the participant pushes to determine reach distance.The YBT testing protocol assessed absolute reach and normalized distance for each direction, asymmetry between limbs, and composite score.
Normalized reach distance is calculated by dividing reach distance by the limb length.
Asymmetry is the absolute difference between right and left leg and is determined for each reach direction.
The composite score is calculated by summing the reach distance in the three directions, dividing by three times limb length, and multiplying by 100.
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Change from Baseline dynamic balance at 8 weeks
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The countermovement jump (CMJ)
Time Frame: Change from Baseline jump height at 8 weeks
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The CMJ is primarily used to measure an athlete's explosive lower-body power, and has become one of the most frequently used tests by coaches and researchers to indirectly measure power in the lower limbs.
CMJ performance is reported as either jump height(centimeters).
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Change from Baseline jump height at 8 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Tomas Gallego-Izquierdo, Dr., Alcala University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEIM/HU/2018/29
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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