Long-term Effect of an Health Education Program on Daily Physical Activity in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Summary

Main objective: To compare the level of physical activity (PAL) at 12 months in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) between those who completed a health education program and those who did not.

Study patients. Subjects older than 35 years; diagnosis of moderate to very severe COPD (FEV1 \<80% predicted), established at least 3 months; current or former smoker with an accumulated consumption \>10 packs x year; and hospital admission for COPD exacerbation.

Design. Randomized, parallel and open-label clinical trial, controlled with conventional treatment.

Intervention: During hospitalization, selected patients will receive conventional treatment. At discharge, they will be randomized (1:1) to control group \[treatment and follow-up according to conventional clinical practice\] or intervention group \[in addition to conventional treatment and follow-up, the patients will be referred to a nursing consultation for perform two health education sessions, at 15 and 30 days after hospital discharge\].

Measurements. At 15 days and 12 months after discharge, the following determinations will be made: anthropometric characteristics; clinical evaluation (smoking history, date of COPD diagnosis, comorbidities, current medication; health care utilization; moderate or severe COPD exacerbations); questionnaires (mMRC, Charlson, COPD-specific co-morbidity test (COTE), COPD Assessment Test (CAT) and LCADL), spirometry and six-minutes walking test; and evaluation of daily physical activity using an accelerometer.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

OTHER

Health education program

2 sessions, at 15 and 30 days after hospital discharge. The first session will consist of four stages: * Basic formation: basic lung anatomy and physiology, COPD concept, importance of tobacco, diagnostic tests for COPD, and how COPD is treated. * Care in COPD: diet, breathing exercises, physical exercise (walking, cycle, treadmill ...), lifestyle (clothing, hygiene, preening, exercise, rest, sexuality, social relations). * Management of conventional treatment: inhalers, oxygen therapy and smoking cessation. * Action Plan: the patient and the nurse will establish a target about the activities that the patient must perform as well as their frequency and duration, according to WHO guidelines. Second session: changes from the previous session; compliance with the physical activity plan and the deviation causes; weaknesses of the patient; skills in the management of inhalers, oxygen, and breathing exercises; and a new physical activity plan.

OTHER

Conventional management

Treatment and follow-up according to conventional clinical practice (GesEPOC guidelines), including recommendations on healthy habits and lifestyle.

Sponsors & Collaborators

• Hospital Universitario La Paz

  lead OTHER

Principal Investigators

• Francisco Garcia-Rio, MD · Hospital Universitario La Paz, IdiPAZ

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

35 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-10-31

Primary Completion

2025-03-31

Completion

2025-03-31

Countries

• Spain

Study Locations