Patellar AbnormalityNCT03865862
Load Control in Eccentric Exercises in Volleyball Players
A study testing Experimental in people with Patellar Abnormality, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
Trial summary
Introduction. Vertical jump is the main movement in volleyball, and the main etiological factor of patellar tendinopathy. The eccentric exercise has been proved as the most effective intervention in improving this factor. Aim. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Patellar Abnormality
- What is being tested?
- Experimental
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 10 Mar 2019to 20 Jun 2019
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volleyball players
- Federated that at the time of the study compete in clubs of the Community of Madrid
- Over 18 years old.
Who cannot join
- Present a medical diagnosis of injury or illness
- Have suffered a knee injury in the 6 months prior to the study
- Doing some pharmacological or physiotherapy treatment external to the study
- Not signed the informed consent document.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Load Control in Eccentric Exercises in the Increase of the Cross-sectional Area and Pain Threshold of the Patellar Tendon, and of the Strength of the Quadriceps in Volleyball Players. A Randomized Clinical Trial
Introduction. Vertical jump is the main movement in volleyball, and the main etiological factor of patellar tendinopathy. The eccentric exercise has been proved as the most effective intervention in improving this factor.
Aim. Annalise the effectiveness of the load control during the eccentric exercise to increase the cross-sectional area as well as the increase of the pain threshold of the patellar tendon, and the gain of the quadriceps maximum strength, in volleyball older players.
Read more
Study design. Randomized clinical study, simple blind, multicentric and with a follow-up period.
Methods. 40 volleyball players will be recruited, who will be randomized to the two groups: experimental (control of the load based on the RM during the eccentric exercise of quadriceps) and control (without load control). There will be an intervention of 4 weeks with 2 weekly seasons of 10 minutes each. The dependent variables will be: cross-sectional area (ultrasound evaluation), pain threshold in the patellar tendon (analog or digital algometer) and the maximum strength of the quadriceps (linear encoder or estimating the RM). In case of normality of the distribution of the sample, parametric tests will be used: student t-test of related samples (difference between evaluations in each rump) and repeated measures ANOVA (intra- and intergroup effect).
Expected results. To observe an increase in the cross-sectional area, pain-threshold of patellar tendon and quadriceps maximum strength.
- Conditions
- Patellar Abnormality
- Being tested
- Experimental, Control
- Keywords
- Eccentric, Load control, Volleyball, Physiotherapy, Patellar tendon, Randomized clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
Also called Load control in eccentric exercises
The athletes will perform an intervention of 4 weeks, with two weekly sessions, in which the intervention will be performed during the training, with these sessions lasting 10 minutes. During the performance of the intervention, they will perform 3 sets of 15 repetitions of squats in a 25º inclined plane, performing the eccentric phase of the squat in a time of 4 seconds, the concentric phase in 3 seconds, and a rest of 15 seconds between series. This intervention will be performed adding 50% of his OR as external load during the first two weeks, 55% of his MR during the third week, and 60% of his MR in the fourth week of the intervention. During the exercise you can help the physiotherapist who will accompany you to perform the concentric phase without load.
ControlOther
Also called Eccentric exercises
Intervention of 4 weeks, with two weekly sessions, in which the intervention will be carried out during the training, these sessions having a duration of 10 minutes. During the performance of the intervention, they will perform 3 sets of 15 squat repetitions on a 25º inclined plane, performing the eccentric phase of the squat in a time of 4 seconds, the concentric phase in 3 seconds, and a 15-second rest between series. The subjects of this group will perform the protocol using only their own weight as a load.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Intervention of 4 weeks, with two weekly sessions, in which the intervention will be carried out during the training, these sessions having a duration of 10 minutes. During the performance of the intervention, they will perform 3 sets of 15 repetitions of squats in a 25º inclined plane, performing the eccentric phase of the squat in a time of 4 seconds, the concentric phase in 3 seconds, and a rest of 15 seconds between series. Receives: Other: Experimental |
| Control | Active comparator | Intervention of 4 weeks, with two weekly sessions, in which the intervention will be carried out during the training, these sessions having a duration of 10 minutes. During the performance of the intervention, they will perform 3 sets of 15 repetitions of squats in a 25º inclined plane, performing the eccentric phase of the squat in a time of 4 seconds, the concentric phase in 3 seconds, and a rest of 15 seconds between series. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline cross-sectional area of the patellar tendon after treatment and at month
The assessment of the cross-sectional area of the patellar tendon will be assessed by ultrasound measurement. The player must be in the supine position, with the lower limbs resting on a wedge while maintaining a knee flexion of 15-20º. The physiotherapist will make a measurement with the transversal axis of the ultrasound, 1 cm distal to the lower pole of the patella, and with the longitudinal axis to 0.5cm distal of the same pole. In spite of performing the measurement of both lower limbs, only the data of the cross-sectional area of the patellar tendon of the dominant lower limb used by the athlete during the landing of the jump while playing will be analyzed. The unit of measurement will be the centimeter. A higher score in the post-treatment evaluation indicates an improvement in the cross-sectional area of the patellar tendon.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary outcomes (2)
Change from baseline pain threshold to pressure after treatment and at month
The assessment of the pain threshold to the pressure of the patellar tendon will be quantified using a digital algometer. During the measurement, the subject will remain in the supine position, maintaining a knee flexion of 15-20º supported by a wedge. The physiotherapist will apply the algometer directly on the lower edge of the patella, towards the proximal side of the tendon. As in the previous test, despite evaluating the pressure threshold in both lower limbs, only the result of the dominant lower limb will be counted. This test is quantified on a 0-100 points scale, where a higher score will indicate a greater perception of pain under pressure.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline maximum strength of quadriceps after treatment and at month
The assessment of the maximum strength of quadriceps will be an estimate of the MRI, where the subjects, after warming up, will begin the test by raising a load estimated by themselves of their 80% MR and will progressively increase the load to 1 repetition (if the repetition is correct will continue to gain weight until the failed attempt). They will have 5 total attempts resting 1 minute between each attempt. The unit of measurement is the Kg, where a greater amount indicates a greater maximum strength of quadriceps.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start10 Mar 2019
- Primary completion15 Apr 2019
- Study completion20 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellar AbnormalityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Investigación en Hemofilia y Fisioterapia
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Rubén Cuesta-Barriuso, PhD, Principal investigator, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03865862
- Sponsor's protocol ID
- CEX
- Status last verified
- Jan 2020
- First submitted
- 4 Mar 2019
- Last updated
- 27 Jan 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 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Load Control in Eccentric Exercises in the Increase of the Cross-sectional Area and Pain Threshold of the Patellar Tendon, and of the Strength of the Quadriceps in Volleyball Players. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03865862
- Acronym / sponsor ID
- CEX
- Conditions
- Patellar Abnormality
- Keywords
- Eccentric, Load control, Volleyball, Physiotherapy, Patellar tendon, Randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Investigación en Hemofilia y FisioterapiaResearch network
- Study start
- 10 Mar 2019 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 20 Jun 2019 (actual)
- First posted
- 7 Mar 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. Vertical jump is the main movement in volleyball, and the main etiological factor of patellar tendinopathy. The eccentric exercise has been proved as the most effective intervention in improving this factor.
Aim. Annalise the effectiveness of the load control during the eccentric exercise to increase the cross-sectional area as well as the increase of the pain threshold of the patellar tendon, and the gain of the quadriceps maximum strength, in volleyball older players.
Study design. Randomized clinical study, simple blind, multicentric and with a follow-up period.
Methods. 40 volleyball players will be recruited, who will be randomized to the two groups: experimental (control of the load based on the RM during the eccentric exercise of quadriceps) and control (without load control). There will be an intervention of 4 weeks with 2 weekly seasons of 10 minutes each. The dependent variables will be: cross-sectional area (ultrasound evaluation), pain threshold in the patellar tendon (analog or digital algometer) and the maximum strength of the quadriceps (linear encoder or estimating the RM). In case of normality of the distribution of the sample, parametric tests will be used: student t-test of related samples (difference between evaluations in each rump) and repeated measures ANOVA (intra- and intergroup effect).
Expected results. To observe an increase in the cross-sectional area, pain-threshold of patellar tendon and quadriceps maximum strength.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: ExperimentalIntervention of 4 weeks, with two weekly sessions, in which the intervention will be carried out during the training, these sessions having a duration of 10 minutes. During the performance of the intervention, they will perform 3 sets of 15 repetitions of squats in a 25º inclined plane, performing the eccentric phase of the squat in a time of 4 seconds, the concentric phase in 3 seconds, and a rest of 15 seconds between series. |
| Control | Active comparator | Other: ControlIntervention of 4 weeks, with two weekly sessions, in which the intervention will be carried out during the training, these sessions having a duration of 10 minutes. During the performance of the intervention, they will perform 3 sets of 15 repetitions of squats in a 25º inclined plane, performing the eccentric phase of the squat in a time of 4 seconds, the concentric phase in 3 seconds, and a rest of 15 seconds between series. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Volleyball players
- Federated that at the time of the study compete in clubs of the Community of Madrid
- Over 18 years old.
Key exclusion criteria (4 listed)
- Present a medical diagnosis of injury or illness
- Have suffered a knee injury in the 6 months prior to the study
- Doing some pharmacological or physiotherapy treatment external to the study
- Not signed the informed consent document.
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 |
|---|---|---|
| ExperimentalAlso: Load control in eccentric exercisesThe athletes will perform an intervention of 4 weeks, with two weekly sessions, in which the intervention will be performed during the training, with these sessions lasting 10 minutes. During the performance of the intervention, they will perform 3 sets of 15 repetitions of squats in a 25º inclined plane, performing the eccentric phase of the squat in a time of 4 seconds, the concentric phase in 3 seconds, and a rest of 15 seconds between series. This intervention will be performed adding 50% of his OR as external load during the first two weeks, 55% of his MR during the third week, and 60% of his MR in the fourth week of the intervention. During the exercise you can help the physiotherapist who will accompany you to perform the concentric phase without load. | Other | Experimental |
| ControlAlso: Eccentric exercisesIntervention of 4 weeks, with two weekly sessions, in which the intervention will be carried out during the training, these sessions having a duration of 10 minutes. During the performance of the intervention, they will perform 3 sets of 15 squat repetitions on a 25º inclined plane, performing the eccentric phase of the squat in a time of 4 seconds, the concentric phase in 3 seconds, and a 15-second rest between series. The subjects of this group will perform the protocol using only their own weight as a load. | Other | Control |
Primary outcome
Change from baseline cross-sectional area of the patellar tendon after treatment and at month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
The assessment of the cross-sectional area of the patellar tendon will be assessed by ultrasound measurement. The player must be in the supine position, with the lower limbs resting on a wedge while maintaining a knee flexion of 15-20º. The physiotherapist will make a measurement with the transversal axis of the ultrasound, 1 cm distal to the lower pole of the patella, and with the longitudinal axis to 0.5cm distal of the same pole. In spite of performing the measurement of both lower limbs, only the data of the cross-sectional area of the patellar tendon of the dominant lower limb used by the athlete during the landing of the jump while playing will be analyzed. The unit of measurement will be the centimeter. A higher score in the post-treatment evaluation indicates an improvement in the cross-sectional area of the patellar tendon.
2 secondary outcomes
Change from baseline pain threshold to pressure after treatment and at month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline maximum strength of quadriceps after treatment and at month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
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 27 Jan 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.
Rubén Cuesta-Barriuso, PhD principal investigator
Universidad Europea de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Patellar Abnormality, run by Investigación en Hemofilia y Fisioterapia 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 3 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 27 Jan 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. 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?
Change from baseline cross-sectional area of the patellar tendon after treatment and at month (time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit). 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 27 Jan 2020.