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Effects of Rehabilitation on Muscle Fibre Composition and Capillaries in Chronic Obstructive Pulmonary Disease (COPD) Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01715337
Recruitment Status : Completed
First Posted : October 26, 2012
Last Update Posted : April 15, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Pulmonary rehabilitation has been established as an evidence-based and recommended therapy in patients with chronic obstructive pulmonary disease (COPD). The aim of our study is to show a potential change in muscle fibre composition and in the amount of capillaries in quadriceps muscle from pre tob post 3-week rehabilitation. Pulmonary rehabilitation includes standardised exercise training, e.g. cycling and strength training for major muscle groups.

Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease Other: pulmonary rehabilitation

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Pulmonary Rehabilitation on Muscle Fibre Composition and Capillaries in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study Start Date : February 2010
Primary Completion Date : March 2013
Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
pulmonary rehabilitation Other: pulmonary rehabilitation
3-week rehabilitation including exercise training, breathing therapy, psychosocial support, medical treatment etc.


Outcome Measures

Primary Outcome Measures :
  1. Change in the amount of capillaries in muscle fibre type I [ Time Frame: change from pre (day 1) to post rehabilitation (day 21) ]

Secondary Outcome Measures :
  1. Change in the amount of capillaries in muscle fibre type IIa [ Time Frame: Change from pre (day 1) to post rehabilitation (day 21) ]
  2. Change in the cross-sectional area of muscle fibre type I [ Time Frame: Change from pre (day 1) to post rehabilitation (day 21) ]
  3. Change in the cross-sectional area of muscle fibre type IIa [ Time Frame: Change from pre (day 1) to post rehabilitation (day 21) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • chronic obstructive pulmonary disease
  • FEV1%pred. < 50%

Exclusion Criteria:

  • acute exacerbation
  • exacerbation in the last 4 weeks
Contacts and Locations

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): NCT01715337


Locations
Germany
Schön Klinik Berchtesgadener Land
Schönau am Königssee, Germany, 83471
Sponsors and Collaborators
Klinikum Berchtesgadener Land der Schön-Kliniken
German Sport University, Cologne
Investigators
Study Chair: Klaus Kenn, Dr. med. Klinikum Berchtesgadener Land
More Information

Responsible Party: Klaus Kenn, Head physician (department of pneumology), Klinikum Berchtesgadener Land der Schön-Kliniken
ClinicalTrials.gov Identifier: NCT01715337     History of Changes
Other Study ID Numbers: COPD muscle 2011
First Posted: October 26, 2012    Key Record Dates
Last Update Posted: April 15, 2014
Last Verified: April 2014

Keywords provided by Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken:
muscle fibre
capillary
rehabilitation
exercise training

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases