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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01380626
First Posted: June 27, 2011
Last Update Posted: December 17, 2013
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.
Collaborators:
Grifols Therapeutics Inc.
Alpha-1 Foundation
Information provided by (Responsible Party):
Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken
  Purpose
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 Alpha-1-antitrypsin-deficiency Procedure: exercise training

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • aerobic and anaerobic enzymes [ Time Frame: day 2 and 23 ]
    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 ]
    Change in max. exercise capacity from baseline to day 23

  • 6-minute-walking distance [ Time Frame: day 3 and 24 ]
    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

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

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

Exclusion Criteria:

  • acute exacerbation
  • exacerbation in the last 4 weeks
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01380626


Locations
Germany
Klinikum Berchtesgadener Land
Berchtesgaden, Germany, 83471
Sponsors and Collaborators
Klinikum Berchtesgadener Land der Schön-Kliniken
Grifols Therapeutics Inc.
Alpha-1 Foundation
Investigators
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
First Submitted: June 22, 2011
First Posted: June 27, 2011
Last Update Posted: December 17, 2013
Last Verified: December 2013

Keywords provided by Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken:
alpha-1-antitrypsin-deficiency
COPD
exercise training
muscle biopsy

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