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COPD, Inflammation and Rehabilitation

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ClinicalTrials.gov Identifier: NCT01700296
Recruitment Status : Completed
First Posted : October 4, 2012
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):
Mimi Christiansen, Naestved Hospital

Tracking Information
First Submitted Date  ICMJE October 2, 2012
First Posted Date  ICMJE October 4, 2012
Last Update Posted Date April 7, 2017
Study Start Date  ICMJE January 2013
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2012)
IL-8 in Sputum [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2012)
IL-8 in serum IL-8 in the BAL fluid [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 2, 2012)
  • walking distance [ Time Frame: 1 year ]
  • exacerbation frequency [ Time Frame: 1 year ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE COPD, Inflammation and Rehabilitation
Official Title  ICMJE COPD, Inflammation and Rehabilitation
Brief Summary

Patients with chronic obstructive pulmonary disease, also known as COPD or emphysema, is like any other with a chronic illness not only affected by the physical discomfort the illness gives. For COPD patients that is: accelerated loss of lung function, conditioning and increased mortality: 25% of patients hospitalized with COPD exacerbation die 12 months later.

Patients are also characterized by various psychological factors such as reduced quality of life, depression, etc.

Therefore, everywhere in the country newly diagnosed COPD patients are offered rehabilitation in Region Zealand which consists of 10 weeks of classes 2 hours, 2 times a week with physical exercise, smoking cessation, medication, nutrition education and psychosocial support and patient education based on the National Health Service and international recommendations.

In the literature, the effect of rehabilitation on quality of life was measured using a questionnaire (St. George Respiratory Questionnaire (SGRQ)), and the increase in function has been measured using a walk test, but there are no studies which look at the effect on inflammation lungs.

It is important for COPD patients is to prevent exacerbations of the disease, which sometimes requires hospitalization and sometimes treated by their own doctor. It has been proven that inflammation in the lungs is associated with disease severity and exacerbation frequency, and therefore we would like to investigate whether both rehabilitation, close monitoring of patients with time in the pulmonary clinic every 3 months, and instruction in self-administration of medication (antibiotics and corticosteroids) have an effect on especially inflammation in the lungs, number of exacerbations, mortality, lung function and walking capacity.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE COPD
Intervention  ICMJE Behavioral: Best care

"Best Care": subjects are randomly assigned to the "Best care" regardless MRC class and severity of symptoms through:

  1. 10 weeks of rehabilitation (2 hours, 2 times a week) by Region Zealand's instructions on sundhed.dk. COPD rehabilitation includes physical exercise, smoking cessation, medication, nutrition education and psychosocial support and patient education. Rehabilitation provided by a multidisciplinary effort with lung nurse, dietician and physiotherapist according to national and international guidelines (1.5) (6) (24) (25)
  2. Outpatient follow-up every 3 months, a total of 5 visits, and during these visits various subjective, clinical, paraclinical and invasive parameters.
Study Arms  ICMJE
  • No Intervention: Standard Care
    "Standard Care": finishing treatment for AECOPD in hospital and after hospital discharge to further control by the GP. In case of severe symptoms and / or airway obstruction (measured by FEV1) refer patients for follow-up in lung clinic. The subjects are recorded with the same subjective, clinical, paraclinical and invasive parameters as the "Best care" group
  • Experimental: Best care

    "Best Care": subjects are randomly assigned to the "Best care" regardless MRC class and severity of symptoms through:

    1. 10 weeks of rehabilitation (2 hours, 2 times a week) by Region Zealand's instructions on sundhed.dk. COPD rehabilitation includes physical exercise, smoking cessation, medication, nutrition education and psychosocial support and patient education. Rehabilitation provided by a multidisciplinary effort with lung nurse, dietician and physiotherapist according to national and international guidelines (1.5) (6) (24) (25)
    2. Outpatient follow-up every 3 months, a total of 5 visits, and during these visits various subjective, clinical, paraclinical and invasive parameters.
    Intervention: Behavioral: Best care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 3, 2016)
47
Original Estimated Enrollment  ICMJE
 (submitted: October 2, 2012)
150
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The study includes consecutive patients over 18 years admitted to the Medical dept, Næstved hospital with AECOPD (2 of 3 symptoms: increased breathlessness, sputum or purulens thereof) on the basis of known COPD (post-bronchodilator FEV1 <80% and FEV1/FVC <70% ; measured in stable phase, ie. earlier than 4 weeks after AECOPD). Patients included during hospitalization for AECOPD

Exclusion Criteria:

  • Patients can not participate if they have asthma (post-bronchodilator FEV1 increased by> 15%), are pregnant, nursing, has known serious comorbidities (eg cancer, chronic liver cirrhosis or hepatitis) or cannot give informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01700296
Other Study ID Numbers  ICMJE 34431
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mimi Christiansen, Naestved Hospital
Study Sponsor  ICMJE Odense University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Odense University Hospital
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP