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

NCT ID: NCT01380626

Last Updated: 2013-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2013-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease Alpha-1-antitrypsin-deficiency

Keywords

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

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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exercise training

Group Type EXPERIMENTAL

exercise training

Intervention Type PROCEDURE

strength and endurance training, 5 time per week.

Interventions

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exercise training

strength and endurance training, 5 time per week.

Intervention Type PROCEDURE

Other Intervention Names

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endurance training strength training

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* acute exacerbation
* exacerbation in the last 4 weeks
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Grifols Therapeutics LLC

INDUSTRY

Sponsor Role collaborator

Alpha-1 Foundation

OTHER

Sponsor Role collaborator

Schön Klinik Berchtesgadener Land

OTHER

Sponsor Role lead

Responsible Party

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Klaus Kenn

Head physician (department of pneumology)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Klaus Kenn, Dr. med.

Role: STUDY_CHAIR

Klinikum Berchtesgadener Land, Schön Klinik

Locations

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Klinikum Berchtesgadener Land

Berchtesgaden, , Germany

Site Status

Countries

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Germany

Other Identifiers

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AAT2010

Identifier Type: -

Identifier Source: org_study_id