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

This study has been completed.
Grifols Therapeutics Inc.
Alpha-1 Foundation
Information provided by (Responsible Party):
Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken
ClinicalTrials.gov Identifier:
First received: June 22, 2011
Last updated: December 16, 2013
Last verified: December 2013
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 Intervention
Chronic Obstructive Pulmonary Disease
Procedure: exercise training

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Klinikum Berchtesgadener Land der Schön-Kliniken:

Primary Outcome Measures:
  • aerobic and anaerobic enzymes [ Time Frame: day 2 and 23 ] [ Designated as safety issue: Yes ]
    changes in quantity of enzymes from baseline to day 23

Secondary Outcome Measures:
  • maximal exercise capacity in incremental cycling test [ Time Frame: day 2 and 23 ] [ Designated as safety issue: No ]
    Change in max. exercise capacity from baseline to day 23

  • 6-minute-walking distance [ Time Frame: day 3 and 24 ] [ Designated as safety issue: No ]
    change in 6-minute-walking distance from baseline to day 24

Enrollment: 20
Study Start Date: February 2010
Study Completion Date: April 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: exercise training Procedure: exercise training
strength and endurance training, 5 time per week.
Other Names:
  • endurance training
  • strength training


Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01380626

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

Responsible Party: Klaus Kenn, Head physician (department of pneumology), Klinikum Berchtesgadener Land der Schön-Kliniken
ClinicalTrials.gov Identifier: NCT01380626     History of Changes
Other Study ID Numbers: AAT2010 
Study First Received: June 22, 2011
Last Updated: December 16, 2013
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on May 26, 2016