Effects of Pulmonary Rehabilitation on Skeletal Muscle in COPD Patients

Not Applicable

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT02915614
• Lead Sponsor: Schön Klinik Berchtesgadener Land

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-21
• Study First Submitted QC: 2016-09-23
• Study First Posted: 2016-09-27
• Study Start: 2017-03-02
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-29
• Last Update Posted: 2022-11-30
• Primary Completion: 2023-12
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Endurance time	3 weeks	Will be measured during a constant work rate cycling test

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Schoen Klinik Berchtesgadener Land; 🇩🇪 Schönau Am Königssee, Germany