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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 01, 2014