- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01715337
Effects of Rehabilitation on Muscle Fibre Composition and Capillaries in Chronic Obstructive Pulmonary Disease (COPD) Patients
April 14, 2014 updated by: Klaus Kenn, Schön Klinik Berchtesgadener Land
Effects of Pulmonary Rehabilitation on Muscle Fibre Composition and Capillaries in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Schönau am Königssee, Germany, 83471
- Schön Klinik Berchtesgadener Land
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- chronic obstructive pulmonary disease
- FEV1%pred. < 50%
Exclusion Criteria:
- acute exacerbation
- exacerbation in the last 4 weeks
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: pulmonary rehabilitation
|
3-week rehabilitation including exercise training, breathing therapy, psychosocial support, medical treatment etc.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in the amount of capillaries in muscle fibre type I
Time Frame: change from pre (day 1) to post rehabilitation (day 21)
|
change from pre (day 1) to post rehabilitation (day 21)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in the amount of capillaries in muscle fibre type IIa
Time Frame: Change from pre (day 1) to post rehabilitation (day 21)
|
Change from pre (day 1) to post rehabilitation (day 21)
|
|
Change in the cross-sectional area of muscle fibre type I
Time Frame: Change from pre (day 1) to post rehabilitation (day 21)
|
Change from pre (day 1) to post rehabilitation (day 21)
|
|
Change in the cross-sectional area of muscle fibre type IIa
Time Frame: Change from pre (day 1) to post rehabilitation (day 21)
|
Change from pre (day 1) to post rehabilitation (day 21)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Klaus Kenn, Dr. med., Klinikum Berchtesgadener Land
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
October 24, 2012
First Submitted That Met QC Criteria
October 25, 2012
First Posted (Estimate)
October 26, 2012
Study Record Updates
Last Update Posted (Estimate)
April 15, 2014
Last Update Submitted That Met QC Criteria
April 14, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COPD muscle 2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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