Effects of Pulmonary Rehabilitation on Skeletal Muscle in COPD Patients

NCT02915614 | Unknown

• 1 other identifier: AAT 2016
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Endurance time

  Will be measured during a constant work rate cycling test

  3 weeks

Secondary Outcomes (3)

• Myofibre type I Distribution

  3 weeks

• Capillary to fibre ratio

  3 weeks

• muscle strength

  3 weeks

Study Arms (2)

PiMM patients

ACTIVE COMPARATOR

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

Procedure: Pulmonary rehabilitation

PiZZ patients

EXPERIMENTAL

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

Procedure: Pulmonary rehabilitation

Interventions

Pulmonary rehabilitation PROCEDURE

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

PiMM patients; PiZZ patients

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Schön Klinik Berchtesgadener Land: lead
• CSL Behring: collaborator

Study Sites (1)

Schoen Klinik Berchtesgadener Land

Schönau am Königssee, 83471, Germany

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; alpha 1-Antitrypsin Deficiency

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Subcutaneous Emphysema; Emphysema

Study Officials

• Klaus Kenn, Prof.

  Department of respiratory medicine, Schoen Klinik Berchtesgadener Land

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Inga Jarosch

CONTACT

+49865293; ijarosch@schoen-kliniken.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head physician, Department of Respiratory Medicine

Study Record Dates

• First Submitted: September 21, 2016
• First Posted: September 27, 2016
• Study Start: March 2, 2017
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: November 30, 2022

Record last verified: 2022-11

Locations

DE (1)