Trial document



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  DRKS00005637

Trial Description

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Title

espiratory muscle activation by respiratory muscle training in patients with advanced COPD

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Trial Acronym

EMG-Train COPD

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URL of the Trial

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Brief Summary in Lay Language

This study aims at assessing the activation of respiratory muscles by respiratory muscle training in patients with chronic obstructive pulmonary disease (COPD). So far respiratory muscle training has been proven to have benefitial effects in healthy subjects and patients with pulmonary diseases such as COPD.

In this study respiratory muscle activity wil be assessed by noninvasive electromyography, which can be compared to writing an ECG. Subjects will perform two bouts of respiratory muscle training with two different modes of respiratory muscle training.

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Brief Summary in Scientific Language

This study aims at examining two modes of respiratory muscle training (Inspiratory threshold loading (ITL) and targeted resistive breathing (TRB)) with respect to respiratory muscle activation (M. sternocleidomastoideus, 2nd intercostal parasternal muscles, diaphragm) by noninvasive surface electromyography in patients with advanced COPD.

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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

  •   DRKS00005637
  •   2014/02/04
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  •   yes
  •   Approved
  •   36/14, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1152-0307 
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Health Condition or Problem studied

  •   J44.89 -  message.icd10.coding.redirected.en
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Interventions/Observational Groups

  •   After obtaining written informed consent from the patients, spirometry and blood gases will be measured. EMG electrodes will be positioned in a semi-rucumbent position after cleansing the skin wih alcohol and abrasive paste. Signal quality will be checked while performing maximal respiratory maneuvers (PImax, Sniff-pressure, breathing to toal lung capacity).
    Then respiratory muscle training (ITL: 2 sets lasting 1min with a break of 3min, TRB: 2 sets lasting 45sec with a break lasting 3min) will be performed in a randomized order. Patients will be sitting in a standardized position in order to minimize postural contamination of the EMG signal. Between the training sessions a 30min rest will be held. Before and after each training session spirometry and blood gases will be measured.
    Study session 1: TRB: targeted resistive breathing: patients will perform controlled breathing through a defined stenosis, applied by a commercially available training device (RespiFit S)
  •   Study session 2: ITL. inspiratory threshold loading: patients breathe through a dedicated respiratory muscle training device (PowerBreath that applies a defined load onto respiration.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Differences in parasternal respiratory muscle activation (expressed as % of acitvation during maximal voluntary breathing maneuvers) applying electromyography during different modes respiratory muscle training (ITL vs TRB). Data recording and evaluation will be during the last breaths of each respiratory training session.

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Secondary Outcome

- resting EMG of the respiratory muscles (M. sternocleidomastoideus, parasternal muscles, diaphragm) for the right / left body side
- maximal innervation as assessed by EMG during maximal voluntary breathing maneuvers (PImax, Sniff, TLC-breathing)
- effect of respiratory muscle training on dynamic hyperinflation, as assesse by spirometric measurement of the inspiratory capacity

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Planned
  •   2014/02/10
  •   15
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Patients with advanced stable hypercapnic COPD and éstablished noninvasive mechanical ventilation

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Exclusion Criteria

- severe hypoxia ((PaO2 < 60mmHg despite oxygen supplementation)
- haemodynamic instability within the last 24h
- neuromuscular disease
- acute infectin (procalcitonin >10 ng/ml and/or CRP > 10 mg/dl)
- missing cooperation
- use of sedative or analgetic agents within the last 6h
- body mass index > 30 kg/m2

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Addresses

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    • Uniklinik Freiburg, Department für Innere Medizin, Klinik für Pneumologie
    • Mr.  Dr. med.  Stephan  Walterspacher 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
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    • Uniklinik Freiburg, Department für Innere Medizin, Klinik für Pneumologie
    • Mr.  Dr. med.  Stephan  Walterspacher 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
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    • Uniklinik Freiburg, Department für Innere Medizin, Klinik für Pneumologie
    • Mr.  Dr. med.  Stephan  Walterspacher 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Uniklinik Freiburg, Department für Innere Medizin, Klinik für Pneumologie
    • Mr.  Dr. med.  Stephan  Walterspacher 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting withdrawn before recruiting started
  •   Other
  •   internal structural issues
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Trial Publications, Results and other Documents

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