Long-term Effect of an Health Education Program on Daily Physical Activity in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Physical activity level
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Intervention group
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.
干预措施: Health education program (Other)
Intervention group
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.
干预措施: Conventional management (Other)
Control group
Conventional management. Treatment and follow-up according to conventional clinical practice (GesEPOC guidelines), including recommendations on healthy habits and lifestyle.
干预措施: Conventional management (Other)
结局指标
主要结局
Physical activity level
时间窗: 12 months
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)
次要结局
- Daily energy expenditure higher than 3 METs(12 months)
- Daily minutes of moderate-high intensity activity(12 months)
- Steps per day(12 months)
- Profile of the daily physical activity(12 months)
- Health-related quality of life(12 months)
- Rate of moderate or severe COPD exacerbations(12 months)
- Relationship between change in physical activity level (PAL) and modification of health-related quality of life(12 months)
- Relationship between change in physical activity level (PAL) and exacerbations rate(12 months)
- Determinants of a clinically relevant increase of the physical activity level(12 months)
研究者
Francisco Garcia-Rio
MD
Hospital Universitario La Paz