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临床试验/NCT03083652
NCT03083652招募中不适用

Effects of Neuromuscular Electrical Stimulation on Exercise Capacity in Respiratory Critically Ill Patients

Hospital Clinic of Barcelona1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017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
招募中
入组人数
40
试验地点
1
主要终点
Exercise capacity

研究概览

简要总结

Neuromuscular electrical stimulation (NMES) implemented during the intensive care unit(ICU) stay may improve exercise capacity and prevent muscular weakness in critically ill patients with respiratory disease. Main objective: To evaluate, in respiratory critically ill patients, the effects of a conventional physiotherapy program with or without additional NMES applied only during the ICU stay on exercise capacity. Design: Randomized, controlled, double-blind clinical trial on patients (>18yo) with diagnosis on admission of acute or acute on chronic respiratory disease, on mechanical ventilation (MV) > 72h and expected MV > 24h. Intervention: Conventional physiotherapy with or without 30-minutes (5days/week) on quadriceps femoris and gluteus maximus. Patients in the control group will follow the same protocol but the device will not be activated. Measures: Demographic data, body composition through bioelectrical impedance analysis (BIA), and functional capacity before admission through Barthel scale will be registered upon inclusion. Exercise capacity through test sit-to stand, muscular strength through Medical Research Council (MRC) score and dynamometry, body composition through BIA, and functional capacity through Barthel scale will be obtained at ICU and hospital discharge.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, 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

  • •Diagnosis at admission: acute or acute on chronic respiratory disease
  • •Mechanical ventilation > 72h at inclusion
  • •Expected mechanical ventilation > 24h
  • •Informed consent

排除标准

  • •Patients re-admitted to ICU (no hospital discharge)
  • •Exitus or transfer to another service/hospital
  • •Respiratory instability [Inspired fraction of oxygen (FIO2) >60% or positive end-expiratory pressure (PEEP) >10 cmH2O] and/or hemodynamic instability [Mean arterial pressure ( MAP)<60mmHg although vasoactive drugs] during > 24h.
  • •Pregnancy
  • •Neuromuscular disease before admission
  • •Skin lesions
  • •Limitation of therapeutic effort
  • •Mental and/or physical limitation to understand/realize tests for evaluation

研究组 & 干预措施

Control

Sham Comparator

Conventional physiotherapy with NMEs device not activated

干预措施: Sham (Other)

Intervention

Experimental

Conventional physiotherapy with daily 30-minutes NMEs (5 days/week)

干预措施: Neuromuscular electrical stimulation (Device)

结局指标

主要结局

Exercise capacity

时间窗: 24h before hospital discharge

Test sit-to-stand

Exercise capacity

时间窗: <48h from ICU discharge

Test sit-to-stand

次要结局

  • Muscle strength(24h before hospital discharge)
  • Body composition (fat free mass)(24h before hospital discharge)
  • Functional Capacity(24h before hospital discharge)
  • Muscle strength(1st day in which collaboration of the patient is ensured (through standardized 5 questions))
  • Muscle strength(<48 from ICU discharge)
  • Body composition (fat free mass)(<48h from inclusion)
  • Body composition (fat free mass)(<48 from ICU discharge)
  • Functional Capacity(<24h from inclusion)

研究者

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

Joan-Daniel Martí Romeu

Principal Investigator

Hospital Clinic of Barcelona

研究点 (1)

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