Effects of Rehabilitation on Muscle Fibre Composition and Capillaries in Chronic Obstructive Pulmonary Disease (COPD) Patients
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
pulmonary rehabilitation
Sponsored by
About this trial
This is an interventional basic science trial for Chronic Obstructive Pulmonary Disease focused on measuring muscle fibre, capillary, rehabilitation, exercise training
Eligibility Criteria
Inclusion Criteria:
- chronic obstructive pulmonary disease
- FEV1%pred. < 50%
Exclusion Criteria:
- acute exacerbation
- exacerbation in the last 4 weeks
Sites / Locations
- Schön Klinik Berchtesgadener Land
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
pulmonary rehabilitation
Arm Description
Outcomes
Primary Outcome Measures
Change in the amount of capillaries in muscle fibre type I
Secondary Outcome Measures
Change in the amount of capillaries in muscle fibre type IIa
Change in the cross-sectional area of muscle fibre type I
Change in the cross-sectional area of muscle fibre type IIa
Full Information
NCT ID
NCT01715337
First Posted
October 24, 2012
Last Updated
April 14, 2014
Sponsor
Schön Klinik Berchtesgadener Land
Collaborators
German Sport University, Cologne
1. Study Identification
Unique Protocol Identification Number
NCT01715337
Brief Title
Effects of Rehabilitation on Muscle Fibre Composition and Capillaries in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official Title
Effects of Pulmonary Rehabilitation on Muscle Fibre Composition and Capillaries in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Schön Klinik Berchtesgadener Land
Collaborators
German Sport University, Cologne
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
muscle fibre, capillary, rehabilitation, exercise training
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pulmonary rehabilitation
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
pulmonary rehabilitation
Intervention Description
3-week rehabilitation including exercise training, breathing therapy, psychosocial support, medical treatment etc.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Change in the amount of capillaries in muscle fibre type IIa
Time Frame
Change from pre (day 1) to post rehabilitation (day 21)
Title
Change in the cross-sectional area of muscle fibre type I
Time Frame
Change from pre (day 1) to post rehabilitation (day 21)
Title
Change in the cross-sectional area of muscle fibre type IIa
Time Frame
Change from pre (day 1) to post rehabilitation (day 21)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
chronic obstructive pulmonary disease
FEV1%pred. < 50%
Exclusion Criteria:
acute exacerbation
exacerbation in the last 4 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Kenn, Dr. med.
Organizational Affiliation
Klinikum Berchtesgadener Land
Official's Role
Study Chair
Facility Information:
Facility Name
Schön Klinik Berchtesgadener Land
City
Schönau am Königssee
ZIP/Postal Code
83471
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Effects of Rehabilitation on Muscle Fibre Composition and Capillaries in Chronic Obstructive Pulmonary Disease (COPD) Patients
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