Effects of Exercise Training in Chronic Obstructive Pulmonary Disease Versus Alpha-1-Antitrypsin-deficiency-patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01380626
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : December 17, 2013
Grifols Therapeutics LLC
Alpha-1 Foundation
Information provided by (Responsible Party):
Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken

Brief Summary:
Chronic Obstructive Pulmonary Disease (COPD)-patients (caused by smoking-level) and Alpha-1-Antitrypsin-deficiency patients showed different developments during rehabilitation in regard to improvement of 6-minute-walking distance. The aim of this study is to investigate differences between training adaptations in COPD-patients and Alpha-1-deficiency patients. Both groups take part in a standardized multimodal 3-week-rehabilitation with strength and endurance training. In addition to conventional diagnostic procedures, muscle biopsies from the M. vastus lateralis will be conducted before and after rehabilitation program followed by biochemical, histochemical and immunohistochemical analysis of the probes.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Alpha-1-antitrypsin-deficiency Procedure: exercise training Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Exercise Training on Quadriceps Gene Expression in COPD-patients in Comparison to Alpha-1-Antitrypsin-deficiency-patients
Study Start Date : February 2010
Actual Primary Completion Date : March 2013
Actual Study Completion Date : April 2013

Arm Intervention/treatment
Experimental: exercise training Procedure: exercise training
strength and endurance training, 5 time per week.
Other Names:
  • endurance training
  • strength training

Primary Outcome Measures :
  1. aerobic and anaerobic enzymes [ Time Frame: day 2 and 23 ]
    changes in quantity of enzymes from baseline to day 23

Secondary Outcome Measures :
  1. maximal exercise capacity in incremental cycling test [ Time Frame: day 2 and 23 ]
    Change in max. exercise capacity from baseline to day 23

  2. 6-minute-walking distance [ Time Frame: day 3 and 24 ]
    change in 6-minute-walking distance from baseline to day 24

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • COPD
  • Alpha-1-Antitrypsine-deficiency, phenotype: ZZ
  • FEV1%pred. <50

Exclusion Criteria:

  • acute exacerbation
  • exacerbation in the last 4 weeks

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01380626

Klinikum Berchtesgadener Land
Berchtesgaden, Germany, 83471
Sponsors and Collaborators
Klinikum Berchtesgadener Land der Schön-Kliniken
Grifols Therapeutics LLC
Alpha-1 Foundation
Study Chair: Klaus Kenn, Dr. med. Klinikum Berchtesgadener Land, Schön Klinik

Responsible Party: Klaus Kenn, Head physician (department of pneumology), Klinikum Berchtesgadener Land der Schön-Kliniken Identifier: NCT01380626     History of Changes
Other Study ID Numbers: AAT2010
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: December 17, 2013
Last Verified: December 2013

Keywords provided by Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken:
exercise training
muscle biopsy

Additional relevant MeSH terms:
Alpha 1-Antitrypsin Deficiency
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Liver Diseases
Digestive System Diseases
Genetic Diseases, Inborn
Subcutaneous Emphysema
Pathologic Processes
Alpha 1-Antitrypsin
Protein C Inhibitor
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action