NCT06053632

Brief Summary

A randomized controlled trial is designed to examine the effects of low-load and high-velocity eccentric exercises on lower limb muscular properties, imbalances and functional status of 13-15 years old female football players.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable healthy

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

Study Start

First participant enrolled

March 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 26, 2023

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

2 months

First QC Date

September 19, 2023

Last Update Submit

September 26, 2023

Conditions

Keywords

Young age soccer playerEccentric hamstring exerciseDynamic balanceContractile muscle properties

Outcome Measures

Primary Outcomes (3)

  • Changes in isokinetic peak torque (with Biodex)

    Knee extension/flexion isokinetic peak torque measurements will be done at 60°/s, 120°/s

    Baseline and after 4 weeks

  • Dynamic balance

    Y-balance Test evaluates lower extremity strength, knee stability and dynamic balance in anterior, posteromedial and posterolateral direction. For each direction, three practice trials were allowed before three test trials were recorded. Mean reach distances (cm) was normalized to leg length, which was measured from the anterior superior iliac spine to the most distal portion of the medial malleolus.

    Baseline and after 4 weeks

  • Changes in muscle contractile characteristics (with tensiomyography (TMG))

    Muscle involuntary contractile characteristics of the lower-limb muscles-the rectus femoris (RF), vastus medialis (VM), vastus lateralis (VL), biceps femoris (BF), semitendinosus (ST), tibialis anterior (TA), gastrocnemius medialis (GM) and gastrocnemius lateralis (GL)-will be recorded by measuring the response of these muscles to an induced electric stimulus (provoked by two self-adhesive electrodes) using TMG equipment on both the left and right lower extremities.

    Baseline and after 4 weeks

Study Arms (2)

Control group

NO INTERVENTION

Control group will be asked to maintain their usual lifestyle.

Experimental group

EXPERIMENTAL

The research group performed additional low-load and high-velocity - lying prone - eccentric hamstring exercise 3 times per week for 4 weeks. 12 sessions in total.

Behavioral: Low-load and high-velocity - lying prone - eccentric hamstring exercise

Interventions

Low-load and high-velocity - lying prone - eccentric hamstring exercise 3 times per week for 4 weeks.

Experimental group

Eligibility Criteria

Age13 Years - 15 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy players able to participate in training and competitions.
  • Playing football for at least 2 years.
  • Regularly participating in team training, 2-3 times a week.

You may not qualify if:

  • Female soccer players with a lower extremity injury (in a period of 6 months)
  • Pain is less than 2 points on the Visual Analog Pain Scale.
  • Irregular exercise
  • The number of years of training attended is too low

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lithuanian Sports University

Kaunas, 44221, Lithuania

Location

Study Officials

  • Dovile Kiele, PhD

    Lithuanian Sports University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 19, 2023

First Posted

September 26, 2023

Study Start

March 1, 2023

Primary Completion

May 1, 2023

Study Completion

May 30, 2023

Last Updated

September 28, 2023

Record last verified: 2023-09

Locations