Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02924870 |
| Other study ID # |
HULP PI-4447 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
October 2016 |
| Est. completion date |
March 2025 |
Study information
| Verified date |
February 2023 |
| Source |
Hospital Universitario La Paz |
| Contact |
Francisco G Garcia-Rio, MD |
| Phone |
+34917277253 |
| Email |
fgr01m[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Objectives: To compare the level of physical activity (PAL) at 12 months in patients with
moderate-very severe COPD between those who completed a health education program and those
who did not.
Secondary objectives: 1) To compare the average of steps per day 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); 2) to compare the
daily minutes of moderate to high intensity at 12 months between the intervention and control
groups; 3) to compare the daily energy expenditure higher than 3 metabolic equivalents (METs)
at 12 months between the intervention and control groups; 4) to compare the distribution
profile of the daily physical activity (very sedentary, sedentary, moderately active) at 12
months between the intervention and control groups; 5) to evaluate the long-term effect of
the health education program on the health-related quality of life of patients with moderate
to very severe COPD; 6) to analyze the effect of the health education program on the risk and
powered rate of moderate or severe COPD exacerbations; 7) to assess the relationship between
the change of the PAL and the modification of the health-related quality of life and the
number of moderate or severe exacerbations; and 8) to identify the determinants of a
clinically relevant increase of the PAL (> 0.14 units) in patients with moderate to very
severe COPD.
METHODS I. Study subjects. Patient selection will be held consecutively in the Department of
Pneumology, University Hospital La Paz-Cantoblanco-Carlos III, according to the following
criteria.
- Inclusion criteria: subjects older than 35 years; diagnosis of moderate to very severe
COPD (FEV1 <80% predicted), according to the GesEPOC criteria [Arch Bronconeumol 2012;48
(Suppl 1):2-58], established at least 3 months; current or former smoker with an
accumulated consumption >10 packs x year; and hospital admission for COPD exacerbation.
- Exclusion criteria: 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.
All participants must sign informed consent approved by the Ethics Committee of University
Hospital La Paz.
II. Design. Randomized, parallel and open-label clinical trial, controlled with conventional
treatment.
A. Protocol and 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
(GesEPOC guidelines), including recommendations on healthy habits and lifestyle.
- 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.
The first session will last about 90 minutes and will consist of four stages:
- Basic formation. The manual "Controlling the COPD", published by the Spanish Society of
Pneumology and Thoracic Surgery (SEPAR) will be handed to participants. The nurse will
individually review the following aspects: basic lung anatomy and physiology, COPD
concept, importance of tobacco, diagnostic tests for COPD (spirometry, blood gases,
sputum cultures, simple radiology, laboratory, walking test), 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 medications;
integration of treatment, and adhesion; 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.
The second session will last approximately 15 minutes and it will be scheduled a month later.
Current situation of the patient and the changes from the previous session will be assessed;
compliance with the physical activity plan and the deviation causes will be analyzed; the
weaknesses of the patient will be strengthened (training, incentives); skills in the
management of inhalers, oxygen, and breathing exercises will be tested; and a new physical
activity plan will be maintained or intensified (WHO guidelines).
There are no therapeutic restrictions for the patients included in the study, which will be
treated by their usual pulmonologist and other health professionals according to their
clinical judgment. Therefore, no limitation is posed to change the usual treatment (including
the prescription of oxygen therapy or noninvasive ventilation) or to schedule follow-up
visits performed by the regular doctor.
B. Sample size. Considering a mean PAL value of 1.55 ± 0.265 in patients with moderate-severe
COPD and an increase of 0.14 units as clinically relevant, since it is associated with a
mortality reduction [Chest 2011;140:331-42], to detect a difference ≥0.14 units, by contrast
bilateral hypothesis (with alpha risk=0.05, beta risk=0.20 and drop-out rate=10%), it is
estimated to will be necessary to randomize 64 patients to each treatment arm.
III. Measurements. At 15 days and 12 months after discharge, the following determinations
will be made:
1. Anthropometric characteristics (sex, age, weight, height, BMI and BSA).
2. Clinical evaluation: Smoking history (cigarettes/day, packs-year), date of COPD
diagnosis, comorbidities, current medication; visits to primary care physician or
pulmonologist (scheduled and unscheduled) and emergency room (date and cause),
hospitalizations (date and cause) and periods off work (date and cause); number and date
of moderate (prescription of antibiotics or systemic corticosteroids) or severe
(hospitalization or stay in the emergency department >24 hours) exacerbations.
3. Questionnaires: mMRC dyspnea scale, Charlson and COTE comorbidity indices, CAT and
LCADL.
4. Spirometry and six-minutes walking test, according current guidelines [Arch Bronconeumol
2013; 49: 388-401; Am J Respir Crit Care Med 2002; 166: 111-7].
5. Evaluation of daily physical activity. It will be made using a Sense Wear accelerometer
(Body Media), that it will be placed on the no dominant arm for 7 consecutive days. The
physical activity level (PAL) will be recorded. Depending on this parameter, the
subjects will be classified as very sedentary (PAL <1.40), sedentary (PAL 1.40 to 1.69)
or moderately active (PAL> 1.70). The mean of steps per day, minutes per day of moderate
to high intensity (>3 METs) and daily energy expenditure >3 METs will be also
determined.
IV. Statistical analysis. T-Student, Mann-Whitney and chi-square test for between-groups
comparisons. Relationship analysis using Pearson correlation and multivariate regression
models. Intention-to-treat evaluation of the main objective with imputation of missing data
by a regression model. The effect of the intervention will be evaluated by the difference of
change for each variable between the two groups using general linear models. The crude effect
(only adjusted for baseline values) and the adjusted effect for several confounders (sex,
age, BMI, smoking, treatment and FEV1%) will be determined.
