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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01418768
Other study ID # CAT2011
Secondary ID
Status Completed
Phase N/A
First received August 9, 2011
Last updated February 1, 2013
Start date August 2011
Est. completion date December 2012

Study information

Verified date February 2013
Source Klinikum Berchtesgadener Land der Schön-Kliniken
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group N/A to 75 Years
Eligibility 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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
inpatient rehabiliation
inpatient, multimodal, individual workout including endurance training, strength training, coordination training etc. for three weeks.

Locations

Country Name City State
Germany Schön Klinik Berchtesgadener Land Schönau am Königssee

Sponsors (1)

Lead Sponsor Collaborator
Klinikum Berchtesgadener Land der Schön-Kliniken

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in CAT-score day 1 to day 21 Yes
Secondary Change in 6 minutes walking distance day 1 to day 21 No
Secondary Change in Short-Form 36 day 1 to day 21 No
Secondary Change in Hospital Anxiety and Depression Scale day 1 to day 21 No
Secondary Change in diffusing capacity day 1 to day 21 No
Secondary Change in forced expiratory volume in 1 second (FEV1) day 1 to day 21 No
Secondary Change in Body Mass index day 1 to day 21 No
Secondary Change in basal energy rate day 1 to day 21 No
Secondary Change in BODE-Index day 1 to day 21 No
Secondary Change in St. George's Respiratory Questionaire Day 1 to day 21 No
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