Sports InjuriesNCT02481063
Adaptation in Lower Extremity After 3 Running Days, With a Group Trained by Eccentric Overload
A study testing Eccentric Overload in people with Sports Injuries, run by Universidad San Jorge at 1 site in Spain.
Trial summary
This study evaluates the changes in muscles and tendons in the lower limb after an intervention of fatigue during 3 consecutive days between trained or not healthy subjects. One of the 2 groups received training by eccentric overload previously. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sports Injuries
- What is being tested?
- Eccentric Overload
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2015to Aug 2015
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects that performs any sport usually
- Subjects that never have made eccentric training will be included.
- Subjects must be willing to perform the procedure
- Sign informed consent
Who cannot join
- Subjects enrolled with lower limb pathology in last 6 months
- Subjects that don´t complete all the procedure will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Differences in Muscle (Vastus Laterals and Gastrocnemius Medialis) and Tendon Adaptation (Patellar and Achilles) in Lower Extremity After 3 Running Days With a Group Trained by Eccentric Overload, Measured by Ultrasound and Thermography
This study evaluates the changes in muscles and tendons in the lower limb after an intervention of fatigue during 3 consecutive days between trained or not healthy subjects. One of the 2 groups received training by eccentric overload previously.
Read the detailed description
Changes in muscle and tendon tissues, due to exercise, could determine in the future the possibility of an injury. Understand the changes in the mechanical tissues is a key tool for prevention.
The evaluation of the thickness and area in tendons, the existence of new vessels within the tendon, muscle pennation angle or thermography are tools that have been widely used to detect these changes.
Running is one of the activities that can cause more muscle-tendon injuries, specially overuse injuries. However, the eccentric exercise suggest to make some adaptations in different tissues that may be beneficial to prevent damage after exercise.
- Conditions
- Sports Injuries
- Being tested
- Control, Eccentric Overload
- Keywords
- Eccentric, Running, Muscle, Tendon, Ultrasound, Thermography
- Medical subject headings
- Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
3 Consecutive Days Running at 80% Maximus Heart Rate
Eccentric OverloadOther
Training with Eccentric Overload (Squat in Yoyo Technology) during 6 Weeks 3 Consecutive Days Running at 80% Maximus Heart Rate
| Study group | Role | What they receive |
|---|---|---|
| Eccentric | Active comparator | 6 Weeks Training with eccentric Overload (Squat with Yoyo Technology) 3 Consecutive Days Running 1 hour at 80% of Maximus Heart Rate Receives: Other: Control; Other: Eccentric Overload |
| Control | Active comparator | 3 Consecutive Days Running 1 hour at 80% of Maximus Heart Rate Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Measure with Ultrasound in Tendons and Muscles
Ultrasound in Patellar and Achilles Tendon, to measure area, thickness and new blood vessels with Doppler.
Ultrasound in Vastus Lateralis and Gastrocnemius Medialis to measure pennation angle
Measured: Change from Baseline in tendon structure, an expected average of 3 days of running
Secondary outcomes (1)
Temperature changes in Patellar and Achilles Tendon as assessed by thermography
Thermography in Patellar and Achilles Tendon in order to measure changes in temperature os these areas of interest
Measured: Change from Baseline in tendon structure after 3 days of running. Just immediately and 10 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sports InjuriesStudies 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad San Jorge
- Sponsor type
- University, hospital or other
- Collaborators
- University of Jaén
- Responsible party
- Sponsor
- Investigators
- César Berzosa, Ph.D, Study director, Universidad San Jorge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02481063
- Sponsor's protocol ID
- TF_US20015
- Status last verified
- Jun 2015
- First submitted
- 27 May 2015
- Last updated
- 21 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Muscle (Vastus Laterals and Gastrocnemius Medialis) and Tendon Adaptation (Patellar and Achilles) in Lower Extremity After 3 Running Days With a Group Trained by Eccentric Overload, Measured by Ultrasound and Thermography
- ClinicalTrials.gov ID
- NCT02481063
- Acronym / sponsor ID
- TF_US20015
- Conditions
- Sports Injuries
- Keywords
- Eccentric, Running, Muscle, Tendon, Ultrasound, Thermography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Universidad San JorgeUniversity, hospital or other
- Collaborators
- University of Jaén
- Study start
- Jun 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 25 Jun 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.
This study evaluates the changes in muscles and tendons in the lower limb after an intervention of fatigue during 3 consecutive days between trained or not healthy subjects. One of the 2 groups received training by eccentric overload previously.
Detailed description
Changes in muscle and tendon tissues, due to exercise, could determine in the future the possibility of an injury. Understand the changes in the mechanical tissues is a key tool for prevention.
The evaluation of the thickness and area in tendons, the existence of new vessels within the tendon, muscle pennation angle or thermography are tools that have been widely used to detect these changes.
Running is one of the activities that can cause more muscle-tendon injuries, specially overuse injuries. However, the eccentric exercise suggest to make some adaptations in different tissues that may be beneficial to prevent damage after exercise.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eccentric | Active comparator | Other: Control, Other: Eccentric Overload6 Weeks Training with eccentric Overload (Squat with Yoyo Technology) 3 Consecutive Days Running 1 hour at 80% of Maximus Heart Rate |
| Control | Active comparator | Other: Control3 Consecutive Days Running 1 hour at 80% of Maximus Heart Rate |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy subjects that performs any sport usually
- Subjects that never have made eccentric training will be included.
- Subjects must be willing to perform the procedure
- Sign informed consent
Key exclusion criteria (2 listed)
- Subjects enrolled with lower limb pathology in last 6 months
- Subjects that don´t complete all the procedure will be excluded.
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 |
|---|---|---|
| Control3 Consecutive Days Running at 80% Maximus Heart Rate | Other | Control, Eccentric |
| Eccentric OverloadTraining with Eccentric Overload (Squat in Yoyo Technology) during 6 Weeks 3 Consecutive Days Running at 80% Maximus Heart Rate | Other | Eccentric |
Primary outcome
Composite Measure with Ultrasound in Tendons and Muscles
Time frame: Change from Baseline in tendon structure, an expected average of 3 days of running
Ultrasound in Patellar and Achilles Tendon, to measure area, thickness and new blood vessels with Doppler. Ultrasound in Vastus Lateralis and Gastrocnemius Medialis to measure pennation angle
1 secondary outcome
Temperature changes in Patellar and Achilles Tendon as assessed by thermography
Time frame: Change from Baseline in tendon structure after 3 days of running. Just immediately and 10 minutes after intervention
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 21 Aug 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.
César Berzosa, Ph.D study director
Universidad San Jorge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eccentric Overload in people with Sports Injuries, run by Universidad San Jorge 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 4 inclusion and 2 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 21 Aug 2015. 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. 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?
Composite Measure with Ultrasound in Tendons and Muscles (time frame: Change from Baseline in tendon structure, an expected average of 3 days of running). 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 21 Aug 2015.