Effect of Education and Respiratory Rehabilitation on Quality of Life in COPD Patients

Not Applicable

• Conditions: COPD
• Interventions: Behavioral: Education program

• Registration Number: NCT03889054
• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz

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.

Study Timeline

• Status Verified: 2019-03
• Study First Submitted: 2019-03-22
• Study First Submitted QC: 2019-03-22
• Last Update Submitted: 2019-03-22
• Study First Posted: 2019-03-25
• Last Update Posted: 2019-03-25
• Study Start: 2019-04-01
• Primary Completion: 2020-04-01
• Study Completion: 2020-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Structured health education program	Education program	Patient will be referred to a specific consultation to carry out this intervention.

Primary Outcome Measures

Name	Time	Method
Quality of life after 6 months of education	Six months	To compare health relate quality of life measured by COPD Assessment Test (CAT) after 6 months between patients who received health education and those who did not receive it.

Secondary Outcome Measures

Name	Time	Method
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.
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 an accelerometer 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.
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.