Trial document





This trial has been registered retrospectively.
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  DRKS00011152

Trial Description

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Title

Influence of a middlefoot construction in running shoes on the metabolism of the ankle joint muscles and modification of the cartilage volume during 60+ minutes of running

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

With this study we want to see the influence of a running shoe on how the different foot muscles are required for running and how this pattern of muscle recruitment changes over time. Another aim of the study is to measure the influence of the running shoe on the mechanical loading in the knee cartilage. Special interest will be paid to the fact, if we can see an earlier or later drift from the individually prefered running pattern which can be correlated with waeriness of the muscles. The muscle recruitment will be measured with MRI and with kinematic sensors during running. Before running the subject will run through a biomechanical testing.

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Brief Summary in Scientific Language

The purpose of this study is to see a connection between cyclic mechanical strain and biological reaction of muscles and joints using running as an example. We will analyse the effect of systematically changed mechanical loading with different types of running shoes on the activation of the extrinsic ankle joint muscles and the cartilage of the knee. Espacially different middle foot constructions of the running shoes will lead to to changes in the kinematic of the foot and the ankle. Due to the interlinking with the tibia, the different construction will show an influence on the knee cartilage as well. The extrinsic ankle joint muscles can´t be shown surface electromyography and just highly invasive and error- prone with the needle electromyography. Because of that the MRI will be chosen to measure the change in T2 relaxation times (which correlates with the activation of the muscle) within the different muscles. To analyse the changes in the knee cartilages water selective sequences will be used to measure the volume and hight of the cartilage of the medial and lateral compartiment before and after the 60+ minutes of running.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00011152
  •   2018/07/02
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  •   yes
  •   Approved
  •   16-375, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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Health Condition or Problem studied

  •   M17.1 -  Other primary gonarthrosis
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Interventions/Observational Groups

  •   Every subject will undergo the same testing with a biomechanical testing in advance and running with different types of running shoes which will be measured with MRI.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

T2 relaxation times of the shank muscles measured with T2 mapping in the MRI at seven different time points.

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Secondary Outcome

Cartilage volume measured with a water selective sequence in the MRI before and after the running intervention.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/12/01
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   20   Years
  •   40   Years
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Additional Inclusion Criteria

age < 40, BMI< 30, physical activity on regular basis

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Exclusion Criteria

Age ≥ 40
BMI ≥ 30
Any contraindication against MRI (pacemakers, cochlea implants, non MRI-compatible devices)
Known cardial diseases
Pain during running
Known degernative disease of the knee cartilage
Prior operations on the knee or shank
Knee replacement
Any metall in the body
Large- scale tattoo
Pregnancy
Claustrophobia

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Institut für Diagnostische und Interentionelle Radiologie, Uniklinik Köln
    • Mr.  Univ. Prof. Dr. med.  David  Maintz 
    • 50937
    • Köln  Kerpenerstr. 62
    • Germany
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    • Institut für Diagnostische und Interventionelle Radiologie
    • Mr.  Dr. med.  Grischa  Bratke 
    • Kerpenerstr. 62
    • 50937  Köln
    • Germany
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    • Institut für Diagnostische und Interventionelle Radiologie
    • Mr.  Dr. med.  Grischa  Bratke 
    • Kerpenerstr. 62
    • 50937  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Institut für Diagnostische und Interentionelle Radiologie, Uniklinik Köln
    • Mr.  Univ. Prof. Dr. med.  David  Maintz 
    • 50937
    • Köln  Kerpenerstr. 62
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/10/31
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Trial Publications, Results and other Documents

  •   Ethikvotum
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* This entry means the parameter is not applicable or has not been set.