Physiotherapy Program Intervention in Exacerbation of Chronic Obstructive Pulmonary Disease.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Strength in upper and lower limbs
研究概览
简要总结
Chronic Obstructive Pulmonary Disease (COPD) is a chronic condition. Its evolution can be aggravated in some periods by an increase of the symptoms (above all the cough, the dyspnoea and the quantity of sputum purulence). This is known as exacerbation and it is the most frequent cause of hospital stay, urgences services and death in COPD. A physiotherapy program is carrying out in patients attending to the Hospital because of an exacerbation.
The hypothesis of this study is that a physiotherapy program added to a medical treatment increase the ventilatory function, the physiques variables, decrease depression and anxiety and improve the quality of life. Additionally, it is going to be assessed the effect of physiotherapy in time using phone calls and visits to the patient's home.
详细描述
The benefits added to the respiratory physiotherapy and physical activity have been evidenced previously in the treatment of COPD. This justify the need of a short physiotherapy intervention program regarding to the hospital stay in exacerbation of COPD and a follow-up after the hospital stay.
4% of europeans have been reported to have medical intervention caused by respiratory exacerbation. 20% of these patients are patients with COPD. The mortality of COPD exacerbation is about 14% and 30% if mechanical ventilation is needed.
In order to that, it is very important to improve the quality of life and the recuperation of patients. It is relevant to mention the the high cost associated to this condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD diagnosis with exacerbation.
- •No contraindication of physiotherapy.
- •Signed written consent.
- •Medical approval for inclusion.
排除标准
- •Heart disease.
- •Neurological patients.
- •Contraindications of physiotherapy.
研究组 & 干预措施
Medical treatment
29 people are being recruited in order to the inclusion criteria for the study. Placebo controlled.
干预措施: Medical treatment (Other)
Physiotherapy program+medical treatment
29 people are recruited in order to the inclusion criteria for the study. Experimental group
干预措施: Physiotherapy program+medical treatment (Other)
结局指标
主要结局
Strength in upper and lower limbs
时间窗: baseline, 12 months
Changes from baseline to postintervention during hospital stay in lower and upper limbs strength. The quadriceps and the hand-grip strength is assessed using a dynamometer with a standard protocol allowing three attempts on each side. During each measurement, patients were sitting with their shoulder adducted and elbow flexed to 90°. The maximum value achieved was used in the analyses. This is important in order to quantify the increase of strength Kg/cm2 The test 2-minute step in place is also going to be used for this purpose, counting the times the patients go up the right knees in two minutes.
次要结局
- Changes in quality of sleep(baseline, 12 months)
- Changes in anxiety and depression(baseline, 12 months)
- Respiratory parameters(baseline, 12 months)
- Activity monitoring(baseline)
- Changes in quality of life(baseline, 12 months)
- Performance of Physical activity(baseline)
研究者
Marie Carmen Valenza
Assistant professor
Universidad de Granada