Trial document





This trial has been registered retrospectively.
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  DRKS00006043

Trial Description

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Title

Comparison Of An Individualized Outpatient Exercise Training Versus A Standardized Outpatient Exercise Training In Patients With Mild To Very Severe Chronic Obstructive Pulmonary Disease

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Trial Acronym

IT vs. NT in COPD Outpatient Rehab

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In chronic obstructive pulmonary disease (COPD), physical training is of great importance. Unfortunately, detailed instruction on the modality within an outpatient setting do not exist.
In this clinical trial, patients be randomly assigned into one of two programs. In "individualized training", patients are trained in a gym to perform endurance and strength building. In "non-individualized training" patients will be trained as part of a group with the help of playful aspects.

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Brief Summary in Scientific Language

Pulmonary rehabilitation is an important treatment option for COPD as it improves exercise capacity, quality of life and reduces the exacerbation rate. Precise recommendations particularly for the outpatient rehabilitation are still missing. This study observes the effect of a short-term, low-intensity rehabilitation program on QoL and other measures.
Therefore, patients will be randomly assigned into an individualized training group or into a non-individualized training group. Both groups will performe training once a week for 60 minutes over a time period of three months. At the beginning and after three months, the following measurements will be assessed: lung function, 6-minute walking test (6-MWT), measurement of health-related quality of life by means of the St. Georges Respiratory Questionnaire (SGRQ) and the COPD-Assessment-Test (CAT), ultrasound measurement of rectus femoris cross-sectional area (M. rect. fem.), and measurement of inflammatory markers in peripheral blood.

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Organizational Data

  •   DRKS00006043
  •   2014/05/12
  •   [---]*
  •   yes
  •   Approved
  •   123/09, Ethik-Kommission des Fachbereichs Medizin der Philipps-Universität Marburg
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Secondary IDs

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

  •   J44.8 -  Other specified chronic obstructive pulmonary disease
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Interventions/Observational Groups

  •   Individualized Training (IT): Patients in this group take part in an individualized outpatient exercise training. The program consists of all aspects of exercise training which have been recommended by the joint American College of Chest Physicians and the American Association of Cardiovascular and Pulmonary Rehabilitation (ACCP/AACVPR) clinical practice guidelines.
    Training once a week for 60 minutes over a time period of three months.
  •   Non-individualized Training (NT): Patients participate as part of a group in different exercises including various playful approaches like ball games.
    Training once a week for 60 minutes over a time period of three months.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor, data analyst
  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Health-related Quality of Life (COPD-Assessment-Test) before/after 3-months training period

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Secondary Outcome

1. Lung function (spirometry)
2. Physical exercise capability (6-minute walking test (6-MWT))
3. Quality of Live (St. Georges Respiratory Questionnaire (SGRQ))
4. Muscle mass (ultrasound measurement of rectus femoris cross-sectional area)
5. Systemic inflammation (serum level measurements of inflammatory markers)

All parameter are measured before and after a three months training period.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2010/08/17
  •   41
  •   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

COPD GOLD I - IV
Capable to come to the facilities on a weekly basis

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Exclusion Criteria

Neuromuscular diseases that prevent the patient from exercise training
Any other condition or disease that in the opinion of the investigator puts the patient to an unacceptable risk or prevents him from participating in the program

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Addresses

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    • Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Giessen and Marburg, Philipps-University Marburg, Germany, Member of the German Center for Lung Research (DZL)
    • Mr.  PD Dr. med.  Andreas Rembert  Koczulla 
    • Baldingerstraße
    • 35043  Marburg
    • Germany
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    • Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Giessen and Marburg, Philipps-University Marburg, Germany, Member of the German Center for Lung Research (DZL)
    • Mr.  PD Dr. med.  Andreas Rembert  Koczulla 
    • Baldingerstraße
    • 35043  Marburg
    • Germany
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    • Universitätsklinikum Giessen und Marburg Innere Medizin, Pneumologie
    • Ms.  Ursula  Boas 
    • Baldingerstraße
    • 35043  Marburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Gießen und Marburg, Standort Marburg
    • Baldingerstraße
    • 35033  Marburg
    • Germany
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    • GlaxoSmithKline GmbH und Co KG
    • 80339  München
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2012/11/30
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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.