NCT03966690

Brief Summary

The functional condition of the leg muscles is not only relevant to performance in sports, but is also of great importance in health, prevention and rehabilitation, where not only the general strength level is decisive but also the relationship between individual muscle groups. Among other things the H-Q-ratio (strength ratio of "hamstring" muscles to quadriceps muscles) is often used to diagnose possible imbalances. Isokinetic force measurements have established themselves as the gold standard in competitive football. In this context, however, force tests in the open kinetic chain (OKC) have almost exclusively been used so far. Especially force measurements in the closed kinetic chain (CKC) could have a higher relevance regarding functionality. The H-Q-ratio should better be called the flex-ext-ratio in the CKC due to the involvement of the hip muscles. There is little data in the literature on leg force or flex-ext-ratio in CKC. In particular, there is hardly any comparative data for isokinetic measurement systems in the CKC. Using a cross over design and randomly allocating 28 competitive football players into two groups (n=14 each) that either started tests with the leg press or legcurl device, the investigators assumed (1) a significantly lower flex-ext-ratio in the CKC compared to the OKC, (2) a correlation between the isokinetic measurement systems in the OKC and the CKC, and (3) a significant superiority of the leg press to predict functional performance of the lower limbs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

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

Study Start

First participant enrolled

August 15, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2019

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 29, 2019

Completed
Last Updated

May 31, 2019

Status Verified

May 1, 2019

Enrollment Period

6 months

First QC Date

May 23, 2019

Last Update Submit

May 29, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Leg extension/leg-flexion rate

    Rate of leg extension to leg-flexion

    at baseline

Secondary Outcomes (4)

  • Isokinetic leg extensors strength

    at baseline

  • Isokinetic leg flexors strength

    at baseline

  • Y-Balance Test

    at baseline

  • Maximum jumping height

    at baseline

Study Arms (2)

leg curl device starters

EXPERIMENTAL

Group A randomly assigned to start with legcurl device

Device: Isokinetic leg extension/-flexion on a legpress deviceDevice: Isokinetic leg extension/-flexion on a legcurl device

legpress device starters

EXPERIMENTAL

Group A randomly assigned to start with legpress device

Device: Isokinetic leg extension/-flexion on a legpress deviceDevice: Isokinetic leg extension/-flexion on a legcurl device

Interventions

Maximum strength and rate of leg-flexion /-extension during legpress exercise

leg curl device starterslegpress device starters

Maximum strength and rate of leg-flexion /-extension during legcurl exercise

leg curl device starterslegpress device starters

Eligibility Criteria

Age18 Years - 35 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale elite soccer player
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • male elite soccer players (5th-6th German soccer division)

You may not qualify if:

  • no acute injuries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Medical Physics, University of Erlangen-Nurnberg

Erlangen, 91052, Germany

Location

MeSH Terms

Conditions

Sprains and Strains

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Wolfgang Kemmler, PhD

    Institute of Medical Physics, University of Erlangen-Nürnberg, Germany

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2019

First Posted

May 29, 2019

Study Start

August 15, 2018

Primary Completion

February 15, 2019

Study Completion

May 15, 2019

Last Updated

May 31, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations