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COPD, Inflammation and Rehabilitation

COPD, Inflammation and Rehabilitation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01700296
Enrollment
47
Registered
2012-10-04
Start date
2013-01-31
Completion date
2016-12-31
Last updated
2017-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

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.

Interventions

BEHAVIORALBest 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.

Sponsors

Odense University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
IL-8 in Sputum1 year

Secondary

MeasureTime frame
IL-8 in serum IL-8 in the BAL fluid1 year

Other

MeasureTime frame
walking distance1 year
exacerbation frequency1 year

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026