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
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
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
NCT ID
NCT01418768
First Posted
August 9, 2011
Last Updated
February 1, 2013
Sponsor
Schön Klinik Berchtesgadener Land
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
Learn more about this trial
Effects of an Inpatient Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease (COPD) III/IV
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