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临床试验/NCT02441452
NCT02441452已完成不适用

Functional Capacity of Exercise and Lung Function in Patients Submitted to Early Rehabilitation Program After Nuss Procedure: a Randomized Controlled Trial

Instituto do Coracao0 个研究点目标入组 40 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
主要终点
Functional capacity of exercise ( six-minute walk test)

研究概览

简要总结

The aim of this study was to compare the functional capacity of exercise by six-minute walk test and lung function by spirometry, before and after Nuss procedure in subjects who have undergone the early rehabiliation program with those who were under conventional care. Researchers want to find out if early rehabilitation is a strategy to enhance recovery after Nuss procedure.

详细描述

The replacement of some traditional approaches in surgical care has demonstrated that surgical recovery can be accelerated and convalescence decreased. These multimodal approaches focuses on enhancing recovery and reducing morbidity by reduction of surgical stress,minimal invasive surgery, optimized pain relief, early nutrition and ambulation.

In postoperative, the bed rest leads to the increase in muscle loss and weakness, impairs pulmonary function, predisposes to venous stasis and thromboembolism, increases infection complications and reduces functional capacity even in patients who are not restricted to bed.

However, few studies have focused on when start the mobilization and which effects on functional capacity of exercise and lung function during hospital stay.

In this trial the investigators will consider early rehabilitation to be safe and feasible in Nuss procedure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
14 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • children who are scheduled to undergo a surgical procedure for the correction of pectus excavatum
  • sign the informed consent form
  • independent ambulation
  • ability to understand and follow instructions
  • ability to perform lung function test

排除标准

  • contraindications for epidural catheter placement
  • patients undergoing the open surgical repair of pectus excavatum
  • refusal to do physical exercises on postoperative
  • patients did not perform the six-minute walk test and lung function test on postoperative

结局指标

主要结局

Functional capacity of exercise ( six-minute walk test)

时间窗: participants will be followed for the duration of hospital stay, an expected average of 6 days

Change from baseline in distance walking on hospital discharge

Lung function (spirometry)

时间窗: participants will be followed for the duration of hospital stay, an expected average of 6 days

Change from baseline in lung function on hospital discharge

次要结局

  • Time to first postoperative ambulation(up 2 hour after surgery)
  • Pain intensity(participants will be followed for the duration of hospital stay, an expected average of 6 days)
  • The length of hospital stay(expected average of 6 days)

研究者

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

Sâmia Geórgia Dantas Linhares

Physiotherapist

Instituto do Coracao

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