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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
inpatient rehabiliation
Sponsored by
Schön Klinik Berchtesgadener Land
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, CAT, Rehabilitation, chronic obstructive pulmonary disease GOLD III/IV

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Schön Klinik Berchtesgadener Land

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rehabilitation

Arm Description

Outcomes

Primary Outcome Measures

Change in CAT-score

Secondary Outcome Measures

Change in 6 minutes walking distance
Change in Short-Form 36
Change in Hospital Anxiety and Depression Scale
Change in diffusing capacity
Change in forced expiratory volume in 1 second (FEV1)
Change in Body Mass index
Change in basal energy rate
Change in BODE-Index
Change in St. George's Respiratory Questionaire

Full Information

First Posted
August 9, 2011
Last Updated
February 1, 2013
Sponsor
Schön Klinik Berchtesgadener Land
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1. Study Identification

Unique Protocol Identification Number
NCT01418768
Brief Title
Effects of an Inpatient Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease (COPD) III/IV
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Schön Klinik Berchtesgadener Land

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, CAT, Rehabilitation, chronic obstructive pulmonary disease GOLD III/IV

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rehabilitation
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
inpatient rehabiliation
Intervention Description
inpatient, multimodal, individual workout including endurance training, strength training, coordination training etc. for three weeks.
Primary Outcome Measure Information:
Title
Change in CAT-score
Time Frame
day 1 to day 21
Secondary Outcome Measure Information:
Title
Change in 6 minutes walking distance
Time Frame
day 1 to day 21
Title
Change in Short-Form 36
Time Frame
day 1 to day 21
Title
Change in Hospital Anxiety and Depression Scale
Time Frame
day 1 to day 21
Title
Change in diffusing capacity
Time Frame
day 1 to day 21
Title
Change in forced expiratory volume in 1 second (FEV1)
Time Frame
day 1 to day 21
Title
Change in Body Mass index
Time Frame
day 1 to day 21
Title
Change in basal energy rate
Time Frame
day 1 to day 21
Title
Change in BODE-Index
Time Frame
day 1 to day 21
Title
Change in St. George's Respiratory Questionaire
Time Frame
Day 1 to day 21

10. Eligibility

Sex
All
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Schön Klinik Berchtesgadener Land
City
Schönau am Königssee
ZIP/Postal Code
83471
Country
Germany

12. IPD Sharing Statement

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

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