Trial document




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  DRKS00004609

Trial Description

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Title

Efficiency of inspiratory muscle Training (IMT) as an adjunct to pulmonary Rehabilitation (PR) in patients with COPD. A randomised, placebo controlled, single blinded study.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Effects of pulmonary rehabilitation in patients with COPD are evidence based on the highest scientific level. It leads to improvements in exercise capacity and Quality of life.
Until now classical modules like exercise training, patient education, smoking cessation, physiotherapy, inhalation, psychosocial support and nutritional support were used. right now there is growing evidence that s special Training of the inspiratory muscles (IMT = inspiratory muscle training) can result in additional effects. This study was designed to proof whether IMT as an adjunct to the standard pulmonary rehabilitation program can optimize the efficiency of pulmonary rehabilitation.

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Brief Summary in Scientific Language

Effects of pulmonary rehabilitation in patients with COPD are evidence based on the highest scientific level. Many questions still exist on the value of single therapeutic modules to the overall effect. The meaning of IMT as a single therapeutic module, especially as an adjunct to a pulmonary rehabilitation program, is not evidence based yet. This prospective, randomiced Placebo controlled study was designed to proof whether IMT as an adjunct to the standard pulmonary rehabilitation program can optimize the efficiency of pulmonary rehabilitation.

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Organizational Data

  •   DRKS00004609
  •   2013/01/07
  •   [---]*
  •   yes
  •   Approved
  •   12107, Ethik-Kommission der Bayerischen Landesärztekammer
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Secondary IDs

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

  •   J44 -  Other chronic obstructive pulmonary disease
  •   J43 -  Emphysema
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Interventions/Observational Groups

  •   Group "blue": Standard pulmonary Rehabilitation program + IMT (method threshold loading). Standard pulmonary rehabilitation program = 3 weeks. IMT 21 minutes/day
  •   group "violet": standard pulmonary Rehabilitation program + Sham-IMT (breathing through a device without resistance). Standard pulmonary rehabilitation program = 3 weeks. Sham-IMT 21 minutes/day
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

MIP = PI max: Maximum inspiratory pressure [kPa]; TO (start of rehabilitation), T1 (end of rehabilitation). The measurement is performed with a commercially available mouth occlusion pressure gauge made ​​by CareFusion following the recommendations of the German Airway League.

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Secondary Outcome

6-minute walk distance (6-MWD, [m], T0, T1). shortness of breath questionnaires (dyspnoea scale of the Medical Research Council, MRC dyspnoea scale), dyspnoea indices (Transition Dyspnoea Index (TDI) and Baseline Dyspnoea Index / Transitional Dyspnoea Index (BDI / TDI), To, T1, T2 (3 months after rehab), T3 (6 months after rehab), T4 (12 months after rehab); subjective health status (COPD Assessment test, CAT), COPD Disability Index (CDI), generic quality of life (SF 36), disease-specific quality of life (St. George's Respiratory Questionnaire, SGRQ), Clinical COPD Questionnaire, CCQ) T0-T4, lost work days and hospital days (T2-4), number of retirements in the year after rehabilitation (T4).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2013/02/01
  •   420
  •   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

All patients undergoing the at least 3 week inpatient pulmonary Rehabilitation program with a diagnosis of COPD (GOLD II-IV). Patients with hypercapnic respiratory failure - CO2 up to 50 mm Hg or more - are not included.

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Exclusion Criteria

(1) linguistic or cognitive constraints that limit participation and lack of motivation
(2) severe comorbidities that superimpose the results of the outcome criteria in a relevant way; e.g. Tumor, severe cardial or orthopaedic comorbidities, obesity hypoventilation syndrome
(3) hypercapnic respiratory failure (CO2 up to 50 mmHg or more under resting conditions or indicated for intermittent noninvasive Ventilation
(4) decline of written consent

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Addresses

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    • Klinik Bad Reichenhall
    • Mr.  Dr. med.  Konrad  Schultz 
    • Salzburger Str. 8-11
    • 83435  Bad Reichenhall
    • Germany
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    • Klinik Bad Reichenhall der DRV Bayern Süd
    • Mr.  Dr. med.  Konrad  Schultz 
    • Salzburger Str. 8-11
    • 83435  Bad Reichenhall
    • Germany
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    • Klinik Bad Reichenhall
    • Mr.  Dr.  Konrad  Schultz 
    • Salzburger Str. 8-11
    • 83435  Bad Reichenhall
    • Germany
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Sources of Monetary or Material Support

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    • Klinik Bad Reichenhall
    • Salzburger Str.
    • 83435  Bad Reichenhall
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2015/10/31
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Trial Publications, Results and other Documents

  •   Schultz K, Jelusic D, Wittmann M, Krämer B, Huber V, Fuchs S, Lehbert N, Wingart S, Stojanovic D, Göhl O, Alma HJ, de Jong C, van der Molen T, Faller H, Schuler M. Inspiratory muscle training does not improve clinical outcomes in 3-week COPD rehabilitation: results from a randomised controlled trial. Eur Respir J. 2018 Jan 25;51(1).
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* This entry means the parameter is not applicable or has not been set.