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

December 16, 2013 updated by: Klaus Kenn, Schön Klinik Berchtesgadener Land

Effects of Exercise Training on Quadriceps Gene Expression in COPD-patients in Comparison to 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berchtesgaden, Germany, 83471
        • Klinikum Berchtesgadener Land

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • acute exacerbation
  • exacerbation in the last 4 weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
aerobic and anaerobic enzymes
Time Frame: day 2 and 23
changes in quantity of enzymes from baseline to day 23
day 2 and 23

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maximal exercise capacity in incremental cycling test
Time Frame: day 2 and 23
Change in max. exercise capacity from baseline to day 23
day 2 and 23
6-minute-walking distance
Time Frame: day 3 and 24
change in 6-minute-walking distance from baseline to day 24
day 3 and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Schön Klinik Berchtesgadener Land

Collaborators

Grifols Therapeutics LLC
Alpha-1 Foundation

Investigators

  • Study Chair: Klaus Kenn, Dr. med., Klinikum Berchtesgadener Land, Schön Klinik

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

June 22, 2011

First Submitted That Met QC Criteria

June 23, 2011

First Posted (Estimate)

June 27, 2011

Study Record Updates

Last Update Posted (Estimate)

December 17, 2013

Last Update Submitted That Met QC Criteria

December 16, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAT2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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