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

NCT02924870 | Unknown Phase 4

• 1 other identifier: HULP PI-4447
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

health education

Outcome Measures

Primary Outcomes (1)

• Physical activity level

  To compare the physical activity level at 12 months in patients with moderate-very severe COPD between the intervention group (conventional treatment plus health education program) and the control group (conventional treatment)

  12 months

Secondary Outcomes (9)

• Steps per day

  12 months

• Daily minutes of moderate-high intensity activity

  12 months

• Daily energy expenditure higher than 3 METs

  12 months

• Profile of the daily physical activity

  12 months

• Health-related quality of life

  12 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Other: Conventional management

Intervention group

EXPERIMENTAL

Conventional management plus health education program. 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.

Other: Health education program; Other: Conventional management

Interventions

Health education program OTHER

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.

Intervention group

Conventional management OTHER

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

Control group; Intervention group

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• subjects older than 35 years
• diagnosis of moderate to very severe COPD (FEV1 \<80% predicted), according to the GesEPOC criteria, established at least 3 months
• current or former smoker with an accumulated consumption \>10 packs x year
• hospital admission for COPD exacerbation

You may not qualify if:

• osteoarticular, neuromuscular or cognitive limitation that prevents ambulation
• previous diagnosis of active neoplastic disease
• institutionalized patients; alcohol consumption \>60 g/day
• patient belonging to another health sector in the Community of Madrid or other community
• participation in another study within 6 months prior.

Sponsors & Collaborators

• Hospital Universitario La Paz: lead

Study Sites (1)

Hospital Universitario La Paz-IdiPAZ

Madrid, 28046, Spain

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Health Education

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Francisco Garcia-Rio, MD

  Hospital Universitario La Paz, IdiPAZ

  STUDY CHAIR

Central Study Contacts

Francisco G Garcia-Rio, MD

CONTACT

+34917277253; fgr01m@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 2, 2016
• First Posted: October 5, 2016
• Study Start: October 1, 2016
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 3, 2023

Record last verified: 2023-02

Locations

ES (1)