ClinicalTrials.gg
Status unknownNCT03889054EDUEPOCUpdated Mar 25, 2019

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

An interventional study of Education program in COPD, sponsored by Instituto de Investigación Hospital Universitario La Paz. Status unknown. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2019-03-25.

Sponsored by Instituto de Investigación Hospital Universitario La Paz · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
30 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

03

In context

Pulmonary Disease, Chronic Obstructive

4,253 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.

This study's planned enrollment of 66 is close to the median of 70 across 3,008 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Instituto de Investigación Hospital Universitario La Paz is the lead sponsor of 104 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
66 participants (estimated)

Study arms

  • No intervention
    Control

    Current clinical management

  • Active comparator
    Structured health education program

    Patient will be referred to a specific consultation to carry out this intervention.

    Behavioral: Education program

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.

    Also known as: Behavioral management

06

What researchers measure

Primary outcomes

  1. Quality of life after 6 months of education

    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.

    Time frame: Six months

  2. Quality of life after 6 months of education

    To compare health relate quality of life measured by the EuroQoL questionnaire, after 6 months between patients who received health education and those who did not receive it.

    Time frame: Six months

  3. Quality of life after 6 months of education

    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.

    Time frame: Six months

Secondary outcomes

  1. Pulmonary function after 6 months of education

    To compare pulmonary function measured by spirometry after 6 months between patients who received health education and those who did not receive it.

    Time frame: Six months

  2. Distance traveled in the 6-minute walk test and in the shuttle walking test after 6 months of education

    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.

    Time frame: Six months

  3. Adherence to inhaled treatment after 6 months of education

    To compare adherence to inhaled treatment after 6 months between patients who received health education and those who did not receive it.

    Time frame: Six months

  4. Physical activity of patients after 6 months of education

    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.

    Time frame: Six months

  5. Physical activity of patients after 6 months of education

    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.

    Time frame: Six months

  6. Emotional state of patients after 6 months of education

    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.

    Time frame: Six months

  7. Number of visits to the emergency department, number of hospital admissions and days of hospital admission of patients after 6 months of education

    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.

    Time frame: Six months

  8. Number of mild, moderate and severe exacerbations of patients after 6 months of education

    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.

    Time frame: Six months

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Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03889054
Collaborators
GlaxoSmithKline
Responsible party
Sponsor
First posted
Mar 25, 2019
Start date
Apr 1, 2019 (estimated)
Primary completion
Apr 1, 2020 (estimated)
Completion
May 1, 2020 (estimated)
Last update
Mar 25, 2019

Study contacts

Carlos Javier Carpio, Dr
Contact
carlinjavier@hotmail.com
+ 34 647267124

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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