Trial document




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  DRKS00015840

Trial Description

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Title

Heavy Load Eccentric Rotator Cuff Exercises as a Preventive Strategy for Shoulder Pain in CrossFit-Athletes. A prospective three-armed, randomised, controlled pilot study.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Aim of this study is, to investigate whether certain types of exercises can reduce the occurrence of shoulder pain in CrossFit athletes. Therefore, two different exercise programs are compared to one group that does no specific preventive exercises for the shoulder.

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Brief Summary in Scientific Language

Aim of this three-armed study is to investigate, whether eccentric exercises are superior compared to concentric exercises or to no exercises in terms of prevention of shoulder pain in CrossFit athletes. In accordance to their group allocation, participants perform either two eccentric exercises, two concentric exercises or no exercises for the rotator cuff muscles of the shoulder joint. Both groups which have to perform exercises have to perform them twice per week.
The study period lasts 3 months. The primary outcome measurement is pain at rest and maximal pain via NRS. Those values will be obtained by a patient reported trainings and pain diary.

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Organizational Data

  •   DRKS00015840
  •   2019/02/11
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  •   yes
  •   Approved
  •   EK2019-3, Ethikkomission der Brandenburgischen Technischen Universität
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Secondary IDs

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Health Condition or Problem studied

  •   M25 -  Other joint disorders, not elsewhere classified
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Interventions/Observational Groups

  •   Eccentric Exercise Group:
    eccentric exercises for the internal and external rotation of the shoulder joint with resistance induced by a cable tower. The exercises will be performed two to three times per week. The movement is conducted with eccentric muscle contractions. The exercises will be performed over the course of 12 weeks.
  •   Concentric Exercise Group:
    traditional rotator cuff strengthening program for the internal and external rotation with resistance induced by elastic bands. The exercises will be performed over the course of 12 weeks.
  •   Control Group: no additional specific preventive exercises for the shoulder joint over the course of 12 weeks.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   data analyst
  •   Active control (effective treament of control group), Control group receives no treatment
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The outcome measurements are patient-reported-outcome-measurements (PROM). Pain, as the primary outcome measurement, is measured by a numerical rating scale 0-10 with pain at rest and another scale for maximum pain during exercise.
These pain scales are implemented in a trainings and pain diary. This diary will be completed daily in the evening over the course of 12 weeks.

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Secondary Outcome

Adherence to allocated exericse prescription

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Planned
  •   2019/02/11
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   45   Years
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Additional Inclusion Criteria

Doing CrossFit for at least 3 months, having no acute injuries of the shoulder joint and the upper extremities, planning to join CrossFit-classes at least twice per week

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Exclusion Criteria

acute injuries of the upper extremities or the shoulder joint, systemic diseases that reduce the participants ability to match the demands of CrossFit-classes

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Brandenburgische Technische Universität Therapiewissenschaften (II)
    • Mr.  Robert  Schulz 
    • Universitätsplatz 1
    • 01968  Senftenberg
    • Germany
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    • Brandenburgische Technische Universität
    • Mr.  Robert  Schulz 
    • Universitätsplatz 1
    • 01968  Senftenberg
    • Germany
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    • Brandenburgische Technische Universität Cottbus - Senftenberg
    • Mr.  Robert  Schulz 
    • Universitätsplatz 1
    • 01968  Senftenberg
    • Germany
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Sources of Monetary or Material Support

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    • Brandenburgische Technische Universität
    • Mr.  Robert  Schulz 
    • Universitätsplatz 1
    • 01968  Senftenberg
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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