- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01418768
Effects of an Inpatient Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease (COPD) III/IV
February 1, 2013 updated by: Klaus Kenn, Schön Klinik Berchtesgadener Land
The purpose of this study is to determine if there is a change in the CAT-score after an inpatient rehabilitation of three weeks and if it correlates with other common parameters.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
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
-
-
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Schönau am Königssee, Germany, 83471
- Schön Klinik Berchtesgadener Land
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-
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
No older than 75 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- inpatient rehabilitation in Schön Klinik Berchtesgadener Land
- stable COPD(GOLD severity III and IV with and without respiratory insufficiency)
Exclusion Criteria:
- severe exacerbation in the last four weeks
- acute coronary syndrome
- unability to cooperate
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: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Rehabilitation
|
inpatient, multimodal, individual workout including endurance training, strength training, coordination training etc. for three weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in CAT-score
Time Frame: day 1 to day 21
|
day 1 to day 21
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in 6 minutes walking distance
Time Frame: day 1 to day 21
|
day 1 to day 21
|
|
Change in Short-Form 36
Time Frame: day 1 to day 21
|
day 1 to day 21
|
|
Change in Hospital Anxiety and Depression Scale
Time Frame: day 1 to day 21
|
day 1 to day 21
|
|
Change in diffusing capacity
Time Frame: day 1 to day 21
|
day 1 to day 21
|
|
Change in forced expiratory volume in 1 second (FEV1)
Time Frame: day 1 to day 21
|
day 1 to day 21
|
|
Change in Body Mass index
Time Frame: day 1 to day 21
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day 1 to day 21
|
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Change in basal energy rate
Time Frame: day 1 to day 21
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day 1 to day 21
|
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Change in BODE-Index
Time Frame: day 1 to day 21
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day 1 to day 21
|
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Change in St. George's Respiratory Questionaire
Time Frame: Day 1 to day 21
|
Day 1 to day 21
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
August 1, 2011
Primary Completion (Actual)
September 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
August 9, 2011
First Submitted That Met QC Criteria
August 16, 2011
First Posted (Estimate)
August 17, 2011
Study Record Updates
Last Update Posted (Estimate)
February 4, 2013
Last Update Submitted That Met QC Criteria
February 1, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAT2011
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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