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

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ClinicalTrials.gov Identifier: NCT01418768
Recruitment Status : Completed
First Posted : August 17, 2011
Last Update Posted : February 4, 2013
Sponsor:
Information provided by (Responsible Party):
Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken

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.

Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease Other: inpatient rehabiliation

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : August 2011
Primary Completion Date : September 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Rehabilitation Other: inpatient rehabiliation
inpatient, multimodal, individual workout including endurance training, strength training, coordination training etc. for three weeks.



Primary Outcome Measures :
  1. Change in CAT-score [ Time Frame: day 1 to day 21 ]

Secondary Outcome Measures :
  1. Change in 6 minutes walking distance [ Time Frame: day 1 to day 21 ]
  2. Change in Short-Form 36 [ Time Frame: day 1 to day 21 ]
  3. Change in Hospital Anxiety and Depression Scale [ Time Frame: day 1 to day 21 ]
  4. Change in diffusing capacity [ Time Frame: day 1 to day 21 ]
  5. Change in forced expiratory volume in 1 second (FEV1) [ Time Frame: day 1 to day 21 ]
  6. Change in Body Mass index [ Time Frame: day 1 to day 21 ]
  7. Change in basal energy rate [ Time Frame: day 1 to day 21 ]
  8. Change in BODE-Index [ Time Frame: day 1 to day 21 ]
  9. Change in St. George's Respiratory Questionaire [ Time Frame: Day 1 to day 21 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01418768


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

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
First Posted: August 17, 2011    Key Record Dates
Last Update Posted: February 4, 2013
Last Verified: February 2013

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

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