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临床试验/NCT03889054
NCT03889054Unknown不适用

Effect of a Joint Program of Health Education and Respiratory Rehabilitation on the Health-related Quality of Life of Patients With Chronic Obstructive Pulmonary Disease and History of Exacerbation

Instituto de Investigación Hospital Universitario La Paz0 个研究点目标入组 66 人开始时间: 2019年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
66
主要终点
Quality of life after 6 months of education

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
30 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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).

研究组 & 干预措施

Control

No Intervention

Current clinical management

Structured health education program

Active Comparator

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

干预措施: Education program (Behavioral)

结局指标

主要结局

Quality of life after 6 months of education

时间窗: Six months

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.

次要结局

  • Pulmonary function after 6 months of education(Six months)
  • Distance traveled in the 6-minute walk test and in the shuttle walking test after 6 months of education(Six months)
  • Adherence to inhaled treatment after 6 months of education(Six months)
  • Emotional state of patients after 6 months of education(Six months)
  • Number of visits to the emergency department, number of hospital admissions and days of hospital admission of patients after 6 months of education(Six months)
  • Number of mild, moderate and severe exacerbations of patients after 6 months of education(Six months)
  • Physical activity of patients after 6 months of education(Six months)

研究者

申办方类型
Other
责任方
Sponsor

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