Trial document




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  DRKS00005969

Trial Description

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Title

Efficacy of exercises to Muscle MRI in patients with neuromuscular diseases and proband

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Trial Acronym

Muscle MRI

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The efficacy of intensive exercises to musculature is not known. Due MRI it is possible to evaluate the outcome of exercises to the microstructure and quantitation of muscle tissue . 20 patients with neuromuscular diseases and 20 healthy test persons get a training about 3 days. Before and after the 3 days of training they got a MRI and a blood examination. We want to compare the MRI measurement and lab values at this two time points. We hope to show the efficacy with this evaluations.

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Brief Summary in Scientific Language

The efficacy of intensive exercises to musculature is not known. Due MRI it is possible to evaluate the outcome of exercises to the microstructure and quantitation of muscle tissue . 20 patients with neuromuscular diseases and 20 healthy test persons get a training about 3 days. Before and after the 3 days of training they got a MRI and a blood examination. We want to compare the MRI measurement and lab values at this two time points. We hope to show the efficacy with this evaluations.
The measurements will be done at clinical MR Scanner in supine position. The measurement will be performed with different sequences and contrasts. One MRI session last 30 minutes. All MRI data from beginning and end will be compared. We will also look for a correlation with all other parameter.

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Organizational Data

  •   DRKS00005969
  •   2014/03/17
  •   [---]*
  •   yes
  •   Approved
  •   48/14, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   G12.0 -  Infantile spinal muscular atrophy, type I [Werdnig-Hoffman]
  •   G71.0 -  Muscular dystrophy
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Interventions/Observational Groups

  •   health testpersons which complete a standardized training (3 days) on the Galileo Plate for 3 days. Before and after the Training is a MRI and blooddraw scheduled
  •   patient with neuromuscular disease which complete a standardized training (3 days) on the Galileo Plate for 3 days. Before and after the Training is a MRI and blooddraw scheduled.
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Characteristics

  •   Interventional
  •   [---]*
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

awareness about efficacy of the training to the muscle structure of the legs due MRI. Before and after the Training (3 days) is a MRI scheduled.

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Secondary Outcome

evaluation of muscle function due MRI.
Before and after the Training (3 days) is a MRI scheduled.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2014/04/13
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   5   Years
  •   no maximum age
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Additional Inclusion Criteria

patient: children, adolescent and adults with neuromuscular diseases
-testperson: children, adolescent and adults without diseases
Common for both groups:
-age ≥ 5 Jahre
- walk without assistance 10 m
-compliance with training and MRI
-Evidence of signed and dated informed consent/assent document(s) indicating that the
subject (and/or his parent/legal guardian) has been informed of all pertinent aspects of the
trial.

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Exclusion Criteria

- Contraindication for MRI
- Bad medical condition
- Not able to understand the study and give an assent due to mental retardation
- Non compliance
- Fractures in the past 3 month
- -inflammation of the musculoskeletal system
- Venous thrombosis in the past 6 month
- Renal calculus and gallstone
- Acute hernia
- Any lesions at feet
- A surgery in the past 3 month

Special criteria for patients:
- Contractures
- Changed therapy in the last 3 month

Special criteria for testpersons:
- Participation in other trainings for the legs (more than once a week) at the last 6 month

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Addresses

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    • UNIVERSITAETSKLINIKUM FREIBURG Zentrum für Kinderheilkunde und Jugendmedizin Klinik II: Neuropädiatrie und Muskelerkrankungen
    • Mr.  Prof.Dr.med  Rudolf  Korinthenberg 
    • Mathildenstr. 1
    • 79106  Freiburg
    • Germany
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    • UNIVERSITAETSKLINIKUM FREIBURG Zentrum für Kinderheilkunde und Jugendmedizin Klinik II: Neuropädiatrie und Muskelerkrankungen
    • Mr.  PD.Dr.med  Janbernd  Kirschner 
    • Mathildenstr. 1
    • 79106  Freiburg
    • Germany
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    • UNIVERSITAETSKLINIKUM FREIBURG Zentrum für Kinderheilkunde und Jugendmedizin Klinik II: Neuropädiatrie und Muskelerkrankungen
    • Mr.  Dr.med  Constantinos  Anastasopoulos  
    • Mathildenstr. 1
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Uniklinikum FreiburgMedzin PhysikRadiologie und NeuroradiologieZKJ/ Neuropädiatrie
    • Mathildenstr. 1
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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