Trial document





This trial has been registered retrospectively.
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  DRKS00004496

Trial Description

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Title

Electromyographic diagnosis of the muscle function of the thigh in male adolescents with CF- a pilot study.

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Trial Acronym

EMCF

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URL of the Trial

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Brief Summary in Lay Language

Cystic fibrosis (CF) ist the in the white population most frequently occurring multi-organ disease. Hereof affected are particularly the respiratory system, the perspiratory glands, the pancreas, the intestinal mucosa and other organs.
Physical activity and exercise are of rising importance because they are supporting the clearence of the respiratory system and the general health status.
A muscular weakness is frequently seen in Cf-Patients. Regarding the musculus quadriceps femoris a reduction of force and endurance during cyclic load can be observed. This indicates a dysfunction of the muscle function. A certified not invasive method for testing the neuromuscular function and the excitability of a muscle is the electromyography (EMG). In line with this research projekt the question is to be answered if CF causes a change or a deviation of the composition of the muscle fibre types. A specific question will be if sinuslike vibrations cause different effects in CF-Patients and the subjects of the control group.

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Brief Summary in Scientific Language

Cystic fibrosis (CF) ist the in the white population most frequently occurring letal inherent autosomale recessiv multi-organ disease. Hereof affected are particularly the respiratory system, the perspiratory glands, the pancreas, the intestinal mucosa and other organs.
Physical activity and exercise are of rising importance because they are supporting the clearence of the respiratory system and the general health status .
A muscular weakness is frequently seen in Cf-Patients. Regarding the musculus quadriceps femoris a reduction of force and endurance during cyclic load can be observed. This indicates a dysfunction of the muscle function. Besides the local changes a dsyfunction of the neuromuscular activation can be supposed analogue to COPD-Patients. A certified not invasive method for testing the neuromuscular function and the excitability of a muscle is the electromyography (EMG). In line with this research projekt the question is to be answered if CF causes a change or a deviation of the composition of the muscle fibre types. A specific question will be if sinuslike vibrations cause different effects in CF-Patients and the subjects of the control group.

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Organizational Data

  •   DRKS00004496
  •   2013/09/18
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  •   yes
  •   Approved
  •   6243, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

  •   U1111-1140-7074 
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Health Condition or Problem studied

  •   E84 -  Cystic fibrosis
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Interventions/Observational Groups

  •   Measurement (EMG, Vital signs, Isokinetic Biodex, Blood flow, Activity, Qualitiy of life (CFQ 14+R), BIA) also under sinus like whole body vibration
  •   Measurement (EMG, Vital signs, Isokinetic Biodex, Blood flow, Activity, Qualitiy of life (SF-36), BIA) also under sinus like whole body vibration (in the control group without an intervention)
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Basic research/physiological study
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

1. EMG
1.1. median frequenzy
1.2. size of the amplitude
2. M-wave
2.1. lenght of the M-wave
2.2. area of the M-wave
3. exhaustion index, isometric contraction

A. Initial examination:
1. Pulmonary function, BMI Z-Score, BIA, HF, RR, AF
2. Quality of life (CFQ., SF36)
3. Activity HAFKA 18

B. Testablauf:
1. EMG, M-Wave and blood flow (Stimulation) Biodex
2. Biodex (max. arbitrary contraction, isometric) EMG, M-Wave and blood flow
3. EMG, M-Wave and blood flow (Stimulation) Biodex
4. Warm up: Biodex, 10´, isokinetic,
5. EMG, M-Wave and blood flow (Stimulation) Biodex
6. Whole body vibration training 90 seconds: EMG, HF, AF
7. EMG, M-Wave and blood flow (Stimulation) Biodex
8. Break 5`
9. Exhasution: Biodex, 50% isometric contraction, 90 seconds
10. Exhaustion: EMG, M-Wave and blood flow direct after 5´ and 10´ (Stimulation) Biodex
11. Biodex (max. arbitrary contraction, isometric) EMG, M-Wave and blood flow
12. EMG, M-Wave and blood flow (Stimulation) Biodex

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Secondary Outcome

1. vital signs
2. isocinetic Biodex
3. blood flow
4. activity questionnaire HAFKA 18
5. health related quality of life questionnaire SF 36/ CFQ 14+R
6. BIA
> all at start of the research projekt

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/11/01
  •   22
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   15   Years
  •   18   Years
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Additional Inclusion Criteria

CF- Group:
assured cystic fibrosis, existing consent form,
patients must be able to carry out analyzable pulmonary function tests, a physical performance tests (Biodex) and a set of whole body vibration training
stable clinical condition without acute respiratory disease in the last 4 weeks respectively without acute exacerbation of the basic disease
no new additionally diagnosted diseases in the last 3 months

Control group:
existing consent form, patients must be able to carry out analyzable pulmonary function tests, a physical performance tests (Biodex) and a set of whole body vibration training

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Exclusion Criteria

Cf- Group:
patients with problematic microbes (cepacia, MRSA, multiresistant bacteria requiring an isolation)
patients coming to an evaluation regarding a lung transplantation
patients after lung transplantation
patients with an acute respiratory disease in the last 4 weeks respectively with an acute exacerbation of the basic disease
patients with an acute health risk resulting in a raised risk for unwanted side effects or influencing the quality of the study results patients with a good adjusted diabetes mellitus can participate

Control group:
existence of a serious cardiovascular disease, existence of a pulmonary disease, existing of a cardiac pacemaker or a defibrillator, patients with an acute health risk resulting in a raised risk for unwanted side effects or influencing the quality of the study results

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Addresses

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    • Medizinische Hochschule Hannover
    • Carl-Neuberg-Straße 1
    • 30625  Hannover
    • Germany
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    • Institut für Sportmedizin Medizinische Hochschule Hannover
    • Mr.  Lothar  Stein 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Institut für Sportmedizin Medizinische Hochschule Hannover
    • Mr.  Lothar  Stein 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Medizinische Hochschule Hannover
    • Carl-Neuberg-Straße 1
    • 30625  Hannover
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/02/01
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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.