Injury;SportsNCT04078256
The Importance of Exercise to Prevent Injuries in Athletes
A study testing Proprioceptive exercise program and Usual training routine in people with Injury;Sports, run by University of Alcala at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Injury;Sports
- What is being tested?
- Proprioceptive exercise program and Usual training routine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2019to 10 Mar 2020
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Weekly training of at least 15 kilometers.
- At least practice running 6 months for 1-3 times a week.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Injury;Sports
- Being tested
- Proprioceptive exercise program, Usual training routine
- Keywords
- proprioception, running, prevention, injuries
- Medical subject headings
- Athletic Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive exercise programOther
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.
Usual training routineOther
The subjects of the control group (group B) will be informed so that they do not include any change in their usual training routine.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Group will carry out the proprioceptive exercise program during 8 weeks at the begining of the season Receives: Other: Proprioceptive exercise program |
| Control group | Placebo comparator | Control group will continue with their usual training routine Receives: Other: Usual training routine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Joint Position Sense (JPS)
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
Measured: Change from Baseline Joint Position Sense Pressure at 8 weeks
Secondary outcomes (2)
The Y Balance Test (YBT)
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.
Measured: Change from Baseline dynamic balance at 8 weeks
The countermovement jump (CMJ)
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).
Measured: Change from Baseline jump height at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start1 Oct 2019
- Primary completion25 Jan 2020
- Study completion10 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injury;SportsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Daniel Pecos Martín, University of Alcala
- Investigators
- Tomas Gallego-Izquierdo, Dr., Study chair, Alcala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078256
- Sponsor's protocol ID
- CEIM/HU/2018/29
- Status last verified
- May 2020
- First submitted
- 30 Aug 2019
- Last updated
- 26 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTIVENESS OF A PROPRIOCEPTIVE EXERCISE PROGRAM IN THE PREVENTION OF INJURIES IN RECREATIONAL RUNNERS
- ClinicalTrials.gov ID
- NCT04078256
- Acronym / sponsor ID
- CEIM/HU/2018/29
- Conditions
- Injury;Sports
- Keywords
- proprioception, running, prevention, injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 25 Jan 2020 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 6 Sep 2019 (actual)
- 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Proprioceptive exercise programGroup will carry out the proprioceptive exercise program during 8 weeks at the begining of the season |
| Control group | Placebo comparator | Other: Usual training routineControl group will continue with their usual training routine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Weekly training of at least 15 kilometers.
- At least practice running 6 months for 1-3 times a week.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Proprioceptive exercise programGroup 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. | Other | Experimental group |
| Usual training routineThe subjects of the control group (group B) will be informed so that they do not include any change in their usual training routine. | Other | Control group |
Primary outcome
Knee Joint Position Sense (JPS)
Time frame: Change from Baseline Joint Position Sense Pressure at 8 weeks
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
2 secondary outcomes
The Y Balance Test (YBT)
Time frame: Change from Baseline dynamic balance at 8 weeks
The countermovement jump (CMJ)
Time frame: Change from Baseline jump height at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2020.
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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.
Tomas Gallego-Izquierdo, Dr. study chair
Alcala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioceptive exercise program and Usual training routine in people with Injury;Sports, run by University of Alcala at 1 site in Spain.
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: finished, as of the sponsor's last update on 26 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Joint Position Sense (JPS) (time frame: Change from Baseline Joint Position Sense Pressure at 8 weeks). 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 26 May 2020.