Effects of Pulmonary Rehabilitation on Skeletal Muscle in COPD Patients

November 29, 2022 updated by: Klaus Kenn, Schön Klinik Berchtesgadener Land

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

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 Contact

Study Locations

  • Germany
      • Schönau Am Königssee, Germany, 83471
        • Recruiting
        • Schoen Klinik Berchtesgadener Land
        • Contact:

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

25 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: PiMM patients
COPD patients with the Alpha-1 antitrypsin genetic variant "PiMM" (Smoking-related COPD)
Procedure: Pulmonary rehabilitation
3-weeks of inpatient pulmonary Rehabilitation including exercise Training (daily endurance and strength Training)
EXPERIMENTAL: PiZZ patients
COPD patients with alpha-1 antitrypsin deficiency (genotype PiZZ)
Procedure: Pulmonary rehabilitation
3-weeks of inpatient pulmonary Rehabilitation including exercise Training (daily endurance and strength Training)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endurance time
Time Frame: 3 weeks
Will be measured during a constant work rate cycling test
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myofibre type I Distribution
Time Frame: 3 weeks
Skeletal muscle sample will be taken from the M.vastus lateralis via Bergström muscle biopsy needle
3 weeks
Capillary to fibre ratio
Time Frame: 3 weeks
Skeletal muscle sample will be taken from the M.vastus lateralis via Bergström muscle biopsy needle
3 weeks
muscle strength
Time Frame: 3 weeks
strength test in the right knee Extensor and flexor
3 weeks

Collaborators and Investigators

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

Sponsor

Schön Klinik Berchtesgadener Land

Collaborators

CSL Behring

Investigators

  • Principal Investigator: Klaus Kenn, Prof., Department of respiratory medicine, Schoen Klinik Berchtesgadener Land

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 (ACTUAL)

March 2, 2017

Primary Completion (ANTICIPATED)

December 1, 2023

Study Completion (ANTICIPATED)

January 1, 2024

Study Registration Dates

First Submitted

September 21, 2016

First Submitted That Met QC Criteria

September 23, 2016

First Posted (ESTIMATE)

September 27, 2016

Study Record Updates

Last Update Posted (ACTUAL)

November 30, 2022

Last Update Submitted That Met QC Criteria

November 29, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAT 2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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