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临床试验/NCT02836912
NCT02836912已完成不适用

The Efficacy of Pulmonary Rehabilitation Exercise in Home Care for the Non-invasive Ventilator-dependent Elderly With Chronic Obstructive Pulmonary Disease

Kaohsiung Medical University Chung-Ho Memorial Hospital0 个研究点目标入组 28 人开始时间: 2015年12月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
28
主要终点
changed strength of respiratory muscles

研究概览

简要总结

Pulmonary rehabilitation exercise is beneficial for individuals with chronic obstructive pulmonary disease (COPD). However, merely 30% patients know how to do the exercise correctly. Therefore, it is worthy to investigate the applications in clinical practice. In addition, there are no relative research in Taiwan to see effects of an 8-week pulmonary rehabilitation exercise in home care for the non-invasive ventilator-dependent elderly with COPD.

详细描述

According to estimation of the world health organization (WHO), chronic obstructive pulmonary disease (COPD) would become the third major cause of death. Moreover, the lung recovery exercise is proven beneficial for mild, moderate, or severe COPD by the guideline of GOLD. However, research in Taiwan focused on follow-up medical status for mild or moderate COPD in clinics, or weaning of severe COPD in intensive care unit (ICU). There was no relative research investigating non-invasive ventilator-dependent elderly with COPD on home care. Therefore, this study would explore effects of pulmonary rehabilitation exercise for this group. The pulmonary rehabilitation exercise program in this study is divided into two stages in the experimental group. The first four weeks, 10 minutes for each training (upper extremity without loading, exercise of lower extremity, and respiratory muscles), and totally 30 minutes is required. Consequent four weeks, 15 minutes for upper extremity without loading, 15 minutes for exercise of lower extremity, and 10 minutes for training of respiratory muscles, and totally 40 minutes is scheduled.

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
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • age > 65 y/o, and is diagnosed with COPD;
  • is non-invasive ventilator-dependent in home care;
  • is stable evaluated by a doctor;
  • is conscious clear and can perform the exercise (upper, lower extremity, and respiratory muscle training);
  • do not accept exercise training as (4)-mentioned currently

排除标准

  • conscious is not clear enough to perform the exercise training;
  • cannot leave his/her bed independently;
  • cannot wean a ventilator and need to use for 24 hours;
  • severe heart disease (eg. acute myocardial infarction, severe arrhythmia);
  • Oxygen saturation (SPO2) lower than 90% during oxygen therapy
  • fever or acute infections
  • reject to sign consent form
  • age < 20 y/o

研究组 & 干预措施

Regular education

No Intervention

Regular education for COPD, including percussion and posture drainage.

Exercise

Experimental

Besides the same information for the education group, exercise of upper extremity without loading, exercise of lower extremity, and training of respiratory muscles are used for the exercise group.

干预措施: Exercise (Other)

结局指标

主要结局

changed strength of respiratory muscles

时间窗: baseline , 8 weeks, 12 weeks

inspforce(BUEHRINGER.USA)

次要结局

  • changed lung function(baseline , 8 weeks, 12 weeks)
  • changed score of intensity of dyspnea(baseline , 8 weeks, 12 weeks)
  • time of weaning from ventilator(baseline , 8 weeks, 12 weeks)
  • changed value for quality of life(baseline , 8 weeks, 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

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