COPD
Conditions
Brief summary
In patients with COPD and a history of recent exacerbation, to compare the quality of life after completing a joint program of health education and respiratory rehabilitation with those patients who only receive respiratory rehabilitation. To compare lung function, the distance traveled in the 6-minute walk test and in the test of the shuttle between both groups. Also, to compare between both groups adherence to inhaled treatment, physical activity, and emotional condition. Finally, to compare the number of visits to emergencies and hospitalizations, and on the other hand, the number of mild, moderate and severe exacerbations between both groups
Detailed description
In this trial we selected COPD patients with a history of recent exacerbation to be submitted to a respiratory rehabilitation program with or without a individualized program of health education. We try to demonstrate a better improvement in the quality of life after completing a joint program of health education and respiratory rehabilitation in this patients than those one who only receive respiratory rehabilitation. We also want to demonstrate an improvement in lung function, the distance travelled in the 6-minute walk test and in the test of the shuttle, the adherence to inhaled treatment, the physical activity, the emotional condition, the number of visits to emergencies and hospitalizations and the number of mild, moderate and severe exacerbations between both groups.
Interventions
BEHAVIORALEducation program
The education sessions will be given in 3 opportunities (15-30, 45 and at 90 days from diagnosis of the exacerbation) and it will be individualized. The program will include measures of self-care and self-management recommended in patients with COPD: 1. Plan of action in an exacerbation. 2. Education related to COPD. 3. Information on pharmacological medication. 4. Management of the exacerbation. 5. Management of stress and / or anxiety. 6. Nutritional recommendations. 7. Physical exercise recommendations. 8. Healthy lifestyle recommendations. The first session will last 90 minutes and will be explain according to the contents of the manual Controlling COPD. A presentation designed for this purpose will be displayed and this manual will be provided to patients to carry out their reading at home. The second and third sessions will last 15 minutes and the purpose will be to resolve doubts.
Sponsors
GlaxoSmithKline
Instituto de Investigación Hospital Universitario La Paz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Randomized and parallel clinical trial of 66 patients (33 with health education associated with respiratory rehabilitation and 33 only with respiratory rehabilitation). There will be a follow-up of 6 months and 4 visits.
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age over 30 years. * COPD diagnosis according to GesEPOC criteria (FEV 1 / FVC greater 0.7). * Smoker or ex-smoker with a cumulative consumption of more than 10 packages per year. * Exacerbation of COPD diagnosed in the last 15 days.
Exclusion criteria
* Impossibility of obtaining informed consent. * Osteoarticular, neuromuscular or cognitive limitation. * Diagnosis of active neoplastic disease, except epidermoid carcinoma of skin. * Patient with limitation or difficulty to go to the rehabilitation unit to complete the training program. * Participation in another study / trial in the previous 6 months. * Have participated in a respiratory rehabilitation program the previous year (12 previous months).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life after 6 months of education | Six months | To compare the quality of life related to health measured by the Saint George respiratory questionnaire after 6 months between patients who received health education and those who did not receive it. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distance traveled in the 6-minute walk test and in the shuttle walking test after 6 months of education | Six months | To compare the distance traveled in the 6-minute walk test and in the shuttle walking test after 6 months between patients who received health education and those who did not receive it. |
| Adherence to inhaled treatment after 6 months of education | Six months | To compare adherence to inhaled treatment after 6 months between patients who received health education and those who did not receive it. |
| Physical activity of patients after 6 months of education | Six months | To compare the physical activity of patients measured by International Physical Activity Questionnaire (IPAQ) after 6 months between patients who received health education and those who did not receive it. |
| Pulmonary function after 6 months of education | Six months | To compare pulmonary function measured by spirometry after 6 months between patients who received health education and those who did not receive it. |
| Number of visits to the emergency department, number of hospital admissions and days of hospital admission of patients after 6 months of education | Six months | To compare the number of visits to the emergency department, the number of hospital admissions and the days of hospital admission after 6 months between patients who received health education and those who did not receive it. |
| Number of mild, moderate and severe exacerbations of patients after 6 months of education | Six months | To compare the number of mild, moderate and severe exacerbations after 6 months between patients who received health education and those who did not receive it. |
| Emotional state of patients after 6 months of education | Six months | To compare the emotional state of patients measured by Hospital Anxiety and Depression Scale (HADS) after 6 months between patients who received health education and those who did not receive it. |
Contacts
Primary ContactCarlos Javier Carpio, Dr
Outcome results
None listed