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Completed

NCT Number: NCT01380626

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Alpha-1-antitrypsin-deficiency Chronic Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Disease Attributes Emphysema Genetic Diseases, Inborn Liver Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Subcutaneous Emphysema alpha 1-Antitrypsin Deficiency

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum Berchtesgadener Land

Berchtesgaden, 83471, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • acute exacerbation
  • exacerbation in the last 4 weeks

Treatment and study plan

Exercise training

Procedure

strength and endurance training, 5 time per week.

Other names: endurance training, strength training

Primary outcomes

  1. aerobic and anaerobic enzymes

    Time frame: day 2 and 23

    changes in quantity of enzymes from baseline to day 23

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Schön Klinik Berchtesgadener Land

Other

Collaborators

  • Alpha-1 Foundation
  • Grifols Therapeutics LLC

Registry information

Official study title

Effects of Exercise Training on Quadriceps Gene Expression in COPD-patients in Comparison to Alpha-1-Antitrypsin-deficiency-patients

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jun 27, 2011
Registry last updated
Dec 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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