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

This study has been completed.
Sponsor:
Collaborators:
Grifols Therapeutics Inc.
Alpha-1 Foundation
Information provided by (Responsible Party):
Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken
ClinicalTrials.gov Identifier:
NCT01380626
First received: June 22, 2011
Last updated: December 16, 2013
Last verified: December 2013
  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: 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

  Eligibility

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

No publications provided

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:
alpha-1-antitrypsin-deficiency
COPD
exercise training
muscle biopsy

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Alpha 1-Antitrypsin Deficiency
Lung Diseases, Obstructive
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
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014