COPD, Inflammation and Rehabilitation

COPD Clinical Trial

Official title:

COPD, Inflammation and Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01700296
• Other study ID #: 34431
• Status: Completed
• Phase: N/A
• First received: October 2, 2012
• Last updated: April 6, 2017
• Start date: January 2013
• Est. completion date: December 2016

Study information

• Verified date: April 2017
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 2016
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Inflammation

Intervention

Behavioral:
• Best care
"Best Care": subjects are randomly assigned to the "Best care" regardless MRC class and severity of symptoms through: 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) Outpatient follow-up every 3 months, a total of 5 visits, and during these visits various subjective, clinical, paraclinical and invasive parameters.

Locations

Country	Name	City	State
Denmark	Naestved Sygehus	Næstved

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	walking distance		1 year
Other	exacerbation frequency		1 year
Primary	IL-8 in Sputum		1 year
Secondary	IL-8 in serum IL-8 in the BAL fluid		1 year