COPD, Inflammation and Rehabilitation

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2012 by Odense University Hospital
Sponsor:
Information provided by (Responsible Party):
Mimi Christiansen, Naestved Hospital
ClinicalTrials.gov Identifier:
NCT01700296
First received: October 2, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted

October 2, 2012
October 2, 2012
October 2012
January 2014   (final data collection date for primary outcome measure)
IL-8 in Sputum [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
IL-8 in serum IL-8 in the BAL fluid [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
  • walking distance [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • exacerbation frequency [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
 
COPD, Inflammation and Rehabilitation
COPD, Inflammation and Rehabilitation

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
COPD
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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
150
January 2015
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Denmark
 
NCT01700296
34431
No
Mimi Christiansen, Naestved Hospital
Odense University Hospital
Not Provided
Not Provided
Odense University Hospital
October 2012

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