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CompletedNCT01380626Updated Dec 17, 2013

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

An interventional study of exercise training in Chronic Obstructive Pulmonary Disease and Alpha-1-antitrypsin-deficiency, sponsored by Schön Klinik Berchtesgadener Land. Completed at 1 site in Germany. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-12-17.

Sponsored by Schön Klinik Berchtesgadener Land · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
20
Ages
40 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease
  • Alpha-1-antitrypsin-deficiency

Keywords

  • alpha-1-antitrypsin-deficiency
  • COPD
  • exercise training
  • muscle biopsy
03

In context

Alpha 1-Antitrypsin Deficiency

94 studies on the registry are indexed under Alpha 1-Antitrypsin Deficiency; 5 are open to participants now.

This study's enrollment of 20 is below the median of 27 across 58 interventional studies indexed under Alpha 1-Antitrypsin Deficiency.

Browse Alpha 1-Antitrypsin Deficiency studies →

Lead sponsor

Schön Klinik Berchtesgadener Land is the lead sponsor of 51 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • acute exacerbation
  • exacerbation in the last 4 weeks
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    exercise training

    Procedure: exercise training

Interventions

  • Procedureexercise training

    strength and endurance training, 5 time per week.

    Also known as: endurance training, strength training

06

What researchers measure

Primary outcomes

  1. aerobic and anaerobic enzymes

    changes in quantity of enzymes from baseline to day 23

    Time frame: day 2 and 23

Secondary outcomes

  1. maximal exercise capacity in incremental cycling test

    Change in max. exercise capacity from baseline to day 23

    Time frame: day 2 and 23

  2. 6-minute-walking distance

    change in 6-minute-walking distance from baseline to day 24

    Time frame: day 3 and 24

07

Study locations

1 site
  • Klinikum Berchtesgadener Land
    Berchtesgaden, 83471, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01380626
Lead sponsor
Schön Klinik Berchtesgadener Land
Collaborators
Grifols Therapeutics LLC, Alpha-1 Foundation
Responsible party
Klaus Kenn (Head physician (department of pneumology), Schön Klinik Berchtesgadener Land) — Principal investigator
First posted
Jun 27, 2011
Start date
Feb 2010
Primary completion
Mar 2013
Completion
Apr 2013
Last update
Dec 17, 2013

Study contacts

Klaus Kenn, Dr. med.
study chair · Klinikum Berchtesgadener Land, Schön Klinik

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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