NCT03865862

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 7, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

March 10, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2019

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

1 month

First QC Date

March 4, 2019

Last Update Submit

January 23, 2020

Conditions

Keywords

EccentricLoad controlVolleyballPhysiotherapyPatellar tendonRandomized clinical trial

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    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

    Screening visit, within the first seven days after treatment and after one month follow-up visit

Study Arms (2)

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.

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.

Other: Control

Interventions

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.

Also known as: Load control in eccentric exercises
Experimental
ControlOTHER

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.

Also known as: Eccentric exercises
Control

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Volleyball players
  • Federated that at the time of the study compete in clubs of the Community of Madrid
  • Over 18 years old.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Europea de Madrid

Madrid, Comunity of Madrid, 28670, Spain

Location

Study Officials

  • Rubén Cuesta-Barriuso, PhD

    Universidad Europea de Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2019

First Posted

March 7, 2019

Study Start

March 10, 2019

Primary Completion

April 15, 2019

Study Completion

June 20, 2019

Last Updated

January 27, 2020

Record last verified: 2020-01

Locations