Effects of an Inpatient Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease (COPD) III/IV

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken

ClinicalTrials.gov Identifier:

NCT01418768

First received: August 9, 2011

Last updated: February 1, 2013

Last verified: February 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	August 9, 2011
Last Updated Date	February 1, 2013
Start Date ^ICMJE	August 2011
Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 16, 2011)	Change in CAT-score [ Time Frame: day 1 to day 21 ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01418768 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 16, 2011)	Change in 6 minutes walking distance [ Time Frame: day 1 to day 21 ] [ Designated as safety issue: No ] Change in Short-Form 36 [ Time Frame: day 1 to day 21 ] [ Designated as safety issue: No ] Change in Hospital Anxiety and Depression Scale [ Time Frame: day 1 to day 21 ] [ Designated as safety issue: No ] Change in diffusing capacity [ Time Frame: day 1 to day 21 ] [ Designated as safety issue: No ] Change in forced expiratory volume in 1 second (FEV1) [ Time Frame: day 1 to day 21 ] [ Designated as safety issue: No ] Change in Body Mass index [ Time Frame: day 1 to day 21 ] [ Designated as safety issue: No ] Change in basal energy rate [ Time Frame: day 1 to day 21 ] [ Designated as safety issue: No ] Change in BODE-Index [ Time Frame: day 1 to day 21 ] [ Designated as safety issue: No ] Change in St. George's Respiratory Questionaire [ Time Frame: Day 1 to day 21 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effects of an Inpatient Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease (COPD) III/IV
Official Title ^ICMJE	Not Provided
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Chronic Obstructive Pulmonary Disease
Intervention ^ICMJE	Other: inpatient rehabiliation inpatient, multimodal, individual workout including endurance training, strength training, coordination training etc. for three weeks.
Study Arm (s)	Experimental: Rehabilitation Intervention: Other: inpatient rehabiliation
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	50
Completion Date	December 2012
Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	up to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT01418768
Other Study ID Numbers ^ICMJE	CAT2011
Has Data Monitoring Committee	No
Responsible Party	Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken
Study Sponsor ^ICMJE	Klinikum Berchtesgadener Land der Schön-Kliniken
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Klinikum Berchtesgadener Land der Schön-Kliniken
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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