Effects of Pulmonary Rehabilitation on Skeletal Muscle in COPD Patients

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02915614
• Other study ID #: AAT 2016
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2017
• Est. completion date: January 2024

Study information

• Verified date: November 2022
• Source: Schön Klinik Berchtesgadener Land
• Contact: Inga Jarosch
• Phone: +49865293
• Email: ijarosch[@]schoen-kliniken.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Procedure:
• Pulmonary rehabilitation
3-weeks of inpatient pulmonary Rehabilitation including exercise Training (daily endurance and strength Training)

Locations

Country	Name	City	State
Germany	Schoen Klinik Berchtesgadener Land	Schönau Am Königssee

Sponsors (2)

Lead Sponsor	Collaborator
Schön Klinik Berchtesgadener Land	CSL Behring

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endurance time	Will be measured during a constant work rate cycling test	3 weeks
Secondary	Myofibre type I Distribution	Skeletal muscle sample will be taken from the M.vastus lateralis via Bergström muscle biopsy needle	3 weeks
Secondary	Capillary to fibre ratio	Skeletal muscle sample will be taken from the M.vastus lateralis via Bergström muscle biopsy needle	3 weeks
Secondary	muscle strength	strength test in the right knee Extensor and flexor	3 weeks