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临床试验/NCT04295655
NCT04295655Unknown不适用

Feasibility and Efficacy of Physiotherapy in Hypoxic AECOPD Patients

Universidad de Granada2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2019年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
36
试验地点
2
主要终点
Fatigue

研究概览

简要总结

Hypoxia is considered a key player in many of the comorbidities that characterize COPD, such as pulmonary hypertension, skeletal muscle dysfunction, and systemic inflammation. These comorbidities are worsened during an exacerbation due to prolonged bed rest and treatment with steroids, showing a reduction in the quality of life, exercise tolerance, and a greater risk of death in these patients. Therefore, a better understanding of the safety and effectiveness of exercise training for AECOPD patients with resting hypoxemia is needed.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Patients of both sexes
  • A diagnosis of COPD made according to the criteria of the American Thoracic Society (ATS)
  • With hypoxemia at rest defined as mean arterial oxygen saturation below 90%
  • Agreed to participate

排除标准

  • Unstable cardiovascular disease
  • Orthopedic diseases in the upper and lower limbs
  • Being in ICU or use of mechanical ventilation
  • Motor sequelae from a neurological or cognitive impairment that interfere with the evaluation and the treatment
  • Contraindications of electrotherapy

结局指标

主要结局

Fatigue

时间窗: Up to 9 days

Fatigue was evaluated using the Piper Fatigue Scale (PFS) that consists of 22 numerical items which assess multidimensional aspects of fatigue. The scale measures four dimensions of subjective fatigue: "behavioral/severity", relating to the severity, distress, and degree of disruption in activity of daily living; "affective meaning", relating to the emotional meaning attributed to fatigue; "sensory", relating to the physical symptoms of fatigue; and "cognitive/mood", relating to mental and mood states

Lower limb strength

时间窗: Up to 9 days

Quadriceps strength was assessed with a portable hand-held dynamometer (Lafayette Manual Muscle Testing System, model 01163, Lafayette, IN, USA). The test was performed with the patient seated with his/her knees and hips flexed at 90°. Resistance was applied to the anterior tibia during 5 seconds of maximal muscle contraction. The test was repeated alternatively 3 times on the leg, allowing participants to rest between measurements. The highest value in Newton was selected for the analysis.

Balance

时间窗: Up to 9 days

Balance was evaluated by the one-leg standing balance test (OLS), that measured the time that the patient balances on one leg as long as possible. The patient choose a leg to stand on (whichever he felt more comfortable with), flex the opposite knee allowing the foot to clear the floor, and balance on one leg. Higher values mean better balance.

Dyspnea

时间窗: Up to 9 days

Dyspnea was assessed at rest using the modified Borg scale. Patients classified their breathlessness from 0 (no dyspnea) to10 (maximal dyspnea)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marie Carmen Valenza

Principal Investigator

Universidad de Granada

研究点 (2)

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