Effects of Pulmonary Rehabilitation on Skeletal Muscle in COPD Patients

NCT ID: NCT02915614

Last Updated: 2022-11-30

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-02

Study Completion Date

2024-01-31

Brief Summary

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In a former study, the investigator observed significant differences in the response to pulmonary rehabilitation between COPD patients with the "normal" genetic variant of alpha-1 antitrypsin (PiMM) and those with a homozygous deficient variant (PiZZ) (Jarosch et al., 2016, DOI: 10.1159/000449509). PiZZ COPD patients showed less improvement in exercise capacity compared to PiMM patients. This latter finding was mirrored by an increase of oxidative myofiber type I proportion - that is important for aerobic exercises in daily life - in PiMM but not PiZZ patients.

Based on this finding of impaired skeletal muscle adaptation, the aim of this study is to compare the effects of pulmonary rehabilitation including exercise training on a) specific enzymes of energy metabolism reflecting the oxidative capacity of the skeletal muscle and b) the analogue gene expression of these oxidative enzymes in a cohort of PiMM and PiZZ COPD patients.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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PiMM patients

COPD patients with the Alpha-1 antitrypsin genetic variant "PiMM" (Smoking-related COPD)

Group Type ACTIVE_COMPARATOR

Pulmonary rehabilitation

Intervention Type PROCEDURE

3-weeks of inpatient pulmonary Rehabilitation including exercise Training (daily endurance and strength Training)

PiZZ patients

COPD patients with alpha-1 antitrypsin deficiency (genotype PiZZ)

Group Type EXPERIMENTAL

Pulmonary rehabilitation

Intervention Type PROCEDURE

3-weeks of inpatient pulmonary Rehabilitation including exercise Training (daily endurance and strength Training)

Interventions

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Pulmonary rehabilitation

3-weeks of inpatient pulmonary Rehabilitation including exercise Training (daily endurance and strength Training)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Chronic obstructive pulmonary disease
* phenotype PiMM or PiZZ
* written informed consent

Exclusion Criteria

* any comorbidities that prevent patients from participating in an exercise Training program
* necessity of anticoagulant therapy
* other genetic variants of alpha-1 antitrypsin than PiMM or PiZZ
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CSL Behring

INDUSTRY

Sponsor Role collaborator

Schön Klinik Berchtesgadener Land

OTHER

Sponsor Role lead

Responsible Party

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Klaus Kenn

Head physician, Department of Respiratory Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Klaus Kenn, Prof.

Role: PRINCIPAL_INVESTIGATOR

Department of respiratory medicine, Schoen Klinik Berchtesgadener Land

Locations

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Schoen Klinik Berchtesgadener Land

Schönau am Königssee, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Inga Jarosch

Role: CONTACT

+49865293 ext. 1730

Facility Contacts

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Inga Jarosch

Role: primary

0049-8652-931730

Other Identifiers

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AAT 2016

Identifier Type: -

Identifier Source: org_study_id

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