跳至主要内容
临床试验/NCT02200198
NCT02200198已完成不适用

Effect of Respiratory Muscle Training in Malnourished Patients Undergoing Upper Abdominal Surgery

University of Sao Paulo General Hospital1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2011年2月1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
45
试验地点
1
主要终点
Expiratory peak flow in spirometry

研究概览

简要总结

Malnutrition affects 50% of hospitalized patients around the world and causes changes in respiratory muscles predisposing the development of pulmonary complications probable, because of the ineffectiveness of cough. How the training of respiratory muscles can improve the effectiveness of cough, malnourished patients could benefit from this train however, the training of the muscles in malnourished patients has not been tested for safety or efficiency. So, the aim of this study is to assess the safety and efficiency of respiratory muscle training to improve the potency of cough in malnourished patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

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

  • •hospitalized malnourished patients (BMI ≤ 20 Kg/m2, loss of body weight ≥ 10% unintentional, or serum albumin <3.5 g/dL)
  • •candidate to elective abdominal surgery
  • •ability to perform all evaluations and training

排除标准

  • •previous respiratory disease
  • •necessity of over than 48h of mechanical ventilation
  • •reoperation

研究组 & 干预措施

Sham group

Sham Comparator

Sham training

干预措施: Sham group (Other)

Inspiratory group

Active Comparator

Inspiratory muscle training

干预措施: Inspiratory muscle training (Other)

Expiratory group

Experimental

Expiratory muscle training

干预措施: Expiratory muscle training (Other)

结局指标

主要结局

Expiratory peak flow in spirometry

时间窗: on the 8th day of protocol (after 7 dyas of training)

Assessed as expiratory peak flow in spirometry

次要结局

  • Maximum respiratory pressures(on the 8th day of protocol (after 7 days of training))
  • Postoperative pulmonary complication(participants will be followed for the duration of hospital stay after surgery, an expected average of 10 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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