Clinical trial NCT03889054: Effect of Education and Respiratory Rehabilitation on Quality of Life in COPD Patients
Official title: Effect of a Joint Program of Health Education and Respiratory Rehabilitation on the Health-related Quality of Life of Patients With Chronic Obstructive Pulmonary Disease and History of Exacerbation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2019-03-25
Enrollment: 66
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Quality of life after 6 months of education
timeFrame: Six months
measure: Quality of life after 6 months of education
timeFrame: Six months
measure: Quality of life after 6 months of education
timeFrame: Six months
Secondary outcomes:
measure: Pulmonary function after 6 months of education
timeFrame: Six months
measure: Distance traveled in the 6-minute walk test and in the shuttle walking test after 6 months of education
timeFrame: Six months
measure: Adherence to inhaled treatment after 6 months of education
timeFrame: Six months
measure: Physical activity of patients after 6 months of education
timeFrame: Six months
measure: Physical activity of patients after 6 months of education
timeFrame: Six months
measure: Emotional state of patients after 6 months of education
timeFrame: Six months
measure: Number of visits to the emergency department, number of hospital admissions and days of hospital admission of patients after 6 months of education
timeFrame: Six months
measure: Number of mild, moderate and severe exacerbations of patients after 6 months of education
timeFrame: Six months
Other outcomes:
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