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Trial record 22 of 22 for:    Recruiting, Not yet recruiting, Available Studies | "alpha 1-Antitrypsin Deficiency"

Effects of Pulmonary Rehabilitation on Skeletal Muscle in COPD Patients

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ClinicalTrials.gov Identifier: NCT02915614
Recruitment Status : Recruiting
First Posted : September 27, 2016
Last Update Posted : March 14, 2018
Sponsor:
Collaborator:
CSL Behring
Information provided by (Responsible Party):
Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken

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.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Procedure: Pulmonary rehabilitation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Pulmonary Rehabilitation on Skeletal Muscle Morphology and Metabolism in PiMM vs. PiZZ COPD Patients
Actual Study Start Date : March 2, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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)




Primary Outcome Measures :
  1. Endurance time [ Time Frame: 3 weeks ]
    Will be measured during a constant work rate cycling test


Secondary Outcome Measures :
  1. Myofibre type I Distribution [ Time Frame: 3 weeks ]
    Skeletal muscle sample will be taken from the M.vastus lateralis via Bergström muscle biopsy needle

  2. 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. muscle strength [ Time Frame: 3 weeks ]
    strength test in the right knee Extensor and flexor



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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic obstructive pulmonary disease (GOLD stage III-IV)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02915614


Contacts
Contact: Inga Jarosch +49865293 ext 1730 ijarosch@schoen-kliniken.de

Locations
Germany
Schoen Klinik Berchtesgadener Land Recruiting
Schönau Am Königssee, Germany, 83471
Contact: Inga Jarosch    0049-8652-931730    ijarosch@schoen-kliniken.de   
Sponsors and Collaborators
Klinikum Berchtesgadener Land der Schön-Kliniken
CSL Behring
Investigators
Principal Investigator: Klaus Kenn, Prof. Department of respiratory medicine, Schoen Klinik Berchtesgadener Land

Responsible Party: Klaus Kenn, Head physician, Department of Respiratory Medicine, Klinikum Berchtesgadener Land der Schön-Kliniken
ClinicalTrials.gov Identifier: NCT02915614     History of Changes
Other Study ID Numbers: AAT 2016
First Posted: September 27, 2016    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken:
alpha-1 antitrypsin deficiency
pulmonary rehabilitation
exercise training
skeletal muscle biopsy

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Alpha 1-Antitrypsin
Protein C Inhibitor
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action