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

I

Instituto de Investigación Hospital Universitario La Paz

Status

Unknown

Conditions

COPD

Treatments

Behavioral: Education program

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03889054
PI-3534

Details and patient eligibility

About

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

Full 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.

Enrollment

66 estimated patients

Sex

All

Ages

30+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

66 participants in 2 patient groups

Control
No Intervention group
Description:
Current clinical management
Structured health education program
Active Comparator group
Description:
Patient will be referred to a specific consultation to carry out this intervention.
Treatment:
Behavioral: Education program

Trial contacts and locations

0

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Central trial contact

Carlos Javier Carpio, Dr

Data sourced from clinicaltrials.gov

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