跳至主要内容
临床试验/NCT00597298
NCT00597298已完成不适用

Randomized Controlled Trial on the Diaphragm Training With Threshold for Patient With Post-Cardiac Surgery Diaphragmatic Paralysis

Ospedali Riuniti Trieste2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2008年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
试验地点
2
主要终点
chest x-ray mobility of the diaphragm

研究概览

简要总结

Diaphragm paralysis is a possible complication of cardiac surgery. The spontaneous recovery of the diaphragm mobility is slow and partial or absent in most cases. We hypothesize that a program of diaphragm muscle training by means of the Threshold variable resistance device could improve the rate of complete diaphragm mobility recovery in a shorter time period. Patient with post-cardiosurgical diaphragm paralysis will be random assigned to the specific training protocol or to a generic non-training physical activity.

详细描述

Inclusion criteria: All consecutive patients aged from 18 to 80 years old with RX-defined diaphragm paralysis post a major cardiosurgery intervention such as coronary bypass, valve substitution or both.

Exclusion criteria: Acute cardiac failure, COPD, chronic respiratory failure with indication to home oxygen therapy, neuromuscular diseases.

Outcome measures: MIP, MEP, diaphragm function recovery assessed by chest X-ray, lung function tests.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • post-cardiosurgical diaphragmatic paralysis recent cardiosurgical intervention for by-pass and/or valve replacement

排除标准

  • heart failure
  • neuromuscular disease

结局指标

主要结局

chest x-ray mobility of the diaphragm

时间窗: 6 and 12 months

次要结局

  • Maximal inspiratory pressure (MIP), cm H2O(6 and 12 months)

研究者

发起方
Ospedali Riuniti Trieste
申办方类型
Other

研究点 (2)

Loading locations...

相似试验