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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
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease
 Other: inpatient rehabiliation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Klinikum Berchtesgadener Land der Schön-Kliniken:

Primary Outcome Measures:
  • Change in CAT-score [ Time Frame: day 1 to day 21 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 50
Study Start Date: August 2011
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rehabilitation Other: inpatient rehabiliation
inpatient, multimodal, individual workout including endurance training, strength training, coordination training etc. for three weeks.

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01418768

Locations
Germany
Schön Klinik Berchtesgadener Land
Schönau am Königssee, Germany, 83471
Sponsors and Collaborators
Klinikum Berchtesgadener Land der Schön-Kliniken
  More Information

No publications provided

Responsible Party: Klaus Kenn, Head physician pneumology, Klinikum Berchtesgadener Land der Schön-Kliniken
ClinicalTrials.gov Identifier: NCT01418768     History of Changes
Other Study ID Numbers: CAT2011
Study First Received: August 9, 2011
Last Updated: February 1, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Klinikum Berchtesgadener Land der Schön-Kliniken:
COPD
CAT
Rehabilitation
chronic obstructive pulmonary disease GOLD III/IV

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013