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Effects of Pulmonary Rehabilitation on Skeletal Muscle in COPD Patients

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Recruiting

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Pulmonary rehabilitation

About this trial

This is an interventional basic science trial for Chronic Obstructive Pulmonary Disease focused on measuring alpha-1 antitrypsin deficiency, pulmonary rehabilitation, exercise training, skeletal muscle biopsy

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Schoen Klinik Berchtesgadener LandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

PiMM patients

PiZZ patients

Arm Description

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

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

Outcomes

Primary Outcome Measures

Endurance time

Will be measured during a constant work rate cycling test

Secondary Outcome Measures

Myofibre type I Distribution

Skeletal muscle sample will be taken from the M.vastus lateralis via Bergström muscle biopsy needle

Capillary to fibre ratio

Skeletal muscle sample will be taken from the M.vastus lateralis via Bergström muscle biopsy needle

muscle strength

strength test in the right knee Extensor and flexor

Full Information

NCT ID

NCT02915614

First Posted

September 21, 2016

Last Updated

November 29, 2022

Sponsor

Schön Klinik Berchtesgadener Land

Collaborators

CSL Behring

1. Study Identification

Unique Protocol Identification Number

NCT02915614

Brief Title

Effects of Pulmonary Rehabilitation on Skeletal Muscle in COPD Patients

Official Title

Effects of Pulmonary Rehabilitation on Skeletal Muscle Morphology and Metabolism in PiMM vs. PiZZ COPD Patients

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 2, 2017 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Schön Klinik Berchtesgadener Land

Collaborators

CSL Behring

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

Keywords

alpha-1 antitrypsin deficiency, pulmonary rehabilitation, exercise training, skeletal muscle biopsy

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PiMM patients

Arm Type

Active Comparator

Arm Description

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

Arm Title

PiZZ patients

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Pulmonary rehabilitation

Intervention Description

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

Primary Outcome Measure Information:

Title

Endurance time

Description

Will be measured during a constant work rate cycling test

Time Frame

3 weeks

Secondary Outcome Measure Information:

Title

Myofibre type I Distribution

Description

Skeletal muscle sample will be taken from the M.vastus lateralis via Bergström muscle biopsy needle

Time Frame

3 weeks

Title

Capillary to fibre ratio

Description

Skeletal muscle sample will be taken from the M.vastus lateralis via Bergström muscle biopsy needle

Time Frame

3 weeks

Title

muscle strength

Description

strength test in the right knee Extensor and flexor

Time Frame

3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Inga Jarosch

Phone

+49865293

Ext

1730

ijarosch@schoen-kliniken.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Klaus Kenn, Prof.

Organizational Affiliation

Department of respiratory medicine, Schoen Klinik Berchtesgadener Land

Official's Role

Principal Investigator

Facility Information:

Facility Name

Schoen Klinik Berchtesgadener Land

City

Schönau Am Königssee

ZIP/Postal Code

83471

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Inga Jarosch

Phone

0049-8652-931730

ijarosch@schoen-kliniken.de

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Effects of Pulmonary Rehabilitation on Skeletal Muscle in COPD Patients

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