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临床试验/NCT07179718
NCT07179718进行中(未招募)不适用

Effects of Two Different Rehabilitation Protocols on Mobility, Functional Status, Muscle Parameters, and Hemodynamic Responses in Intensive Care Patients

Hacettepe University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年6月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
24
试验地点
2
主要终点
Change in Perme Intensive Care Unit Mobility Score over 5 days

研究概览

简要总结

The aim of this study was to investigate the effects of NMES combination applied in addition to bicycle ergometry on mobility, functional status, muscle strength and hemodynamic responses in ICU patients.

Participants will:

  • Exercise training will be performed using the bicycle ergometer method, under the supervision of a physiotherapist, for 30 minutes a day for 5 consecutive days, at the earliest stage when the patient is clinically stable.
  • The other group will perform a 30-minute quadriceps muscle NMES session applied with a 4-channel electrical stimulator for 5 consecutive days in addition to the bicycle ergometer.
  • Evaluations for both groups will be made on the first day of the study (before starting the exercise training) and at the end of the fifth day (after the exercise training).

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
None

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

  • •Age ≥ 18 years
  • •Admitted to medical intensive care unit
  • •Expected intensive care unit stay > 48 hours
  • •Hemodynamically stable

排除标准

  • •Severe neurological injury (e.g., acute stroke, spinal cord injury)
  • •Terminal illness with palliative care decision
  • •Severe orthopedic limitations preventing mobilization
  • •Pregnancy

研究组 & 干预措施

bicycle ergometer group

Experimental

Exercise training will be performed using the bicycle ergometer method, under the supervision of a physiotherapist, for 30 minutes a day for 5 consecutive days, at the earliest stage when the patient is clinically stable.

干预措施: bicycle ergometer (Device)

bicycle ergometer + neuromuscular electrical stimulation group

Experimental

Group will perform a 30-minute quadriceps muscle NMES session applied with a 4-channel electrical stimulator for 5 consecutive days in addition to the bicycle ergometer.

干预措施: neuromuscular electrical stimulation (Device)

bicycle ergometer + neuromuscular electrical stimulation group

Experimental

Group will perform a 30-minute quadriceps muscle NMES session applied with a 4-channel electrical stimulator for 5 consecutive days in addition to the bicycle ergometer.

干预措施: bicycle ergometer (Device)

结局指标

主要结局

Change in Perme Intensive Care Unit Mobility Score over 5 days

时间窗: 1st and 5th day of 5-day physiotherapy and rehabilitation after the patient is clinically stable

The total score ranges from 0 to 32 points, with higher scores indicating better mobility and greater independence.

Change in Perme Intensive Care Unit Mobility Score over 5 days

时间窗: 1st and 5th day of 5-day physiotherapy and rehabilitation after the patient is clinically stable

The total score ranges from 0 to 32 points, with higher scores indicating better mobility and greater independence.

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

SELMAN KILIÇ

Mr.

Hacettepe University

研究点 (2)

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