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临床试验/NCT05342129
NCT05342129已完成不适用

Effects of Exercise Intervention on Muscle Strength in Severely Ill Patients

Taipei Veterans General Hospital, Taiwan1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年7月17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
60
试验地点
1
主要终点
days in intensive care unit

研究概览

简要总结

In recent years, due to the improvement in the survival rate of the intensive care unit, the problem of severe systemic fatigue (Intensive care unit acquired weakness; ICUAW) has continued to receive attention. Muscle mass decreases by 3-11% within a week, resulting in decreased muscle strength and muscle atrophy. Current studies suggest that ICUAW can lead to poorer function, prolonged ICU stay, and decreased quality of life.

This study aimed to understand the muscle strength of critically ill patients and to explore the effect of exercise intervention on improving muscle strength. The experimental group received a four-week exercise bike intervention plus conventional rehabilitation exercises, while the control group received conventional rehabilitation exercises.

详细描述

The content of the exercise is to use an exercise bike, start pedaling on the first day, time setting: 20 minutes, speed: 2, and adopt passive mode. If you can complete the exercise on the first day, the time will be adjusted to 30 minutes on the second day. If you cannot complete the exercise on the first day, the time will still start from 20 minutes on the second day. The maximum time is 30 minutes. If you can complete 30 minutes of passive exercise for 3 consecutive days, the fourth day will be adjusted to active exercise. The entire exercise training is seven days a week, once a day, once a 30-minute, at least 5 days. Those who were discharged to the general ward continued to complete this exercise training for up to 28 days. Stop exercising if heartbeat > 140, mean arterial pressure < 65, blood oxygen < 90%, respiration > 35 beats/min, or the patient requests to stop during exercise.

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged over 20 years old
  • willing to participate in this study, and signed the consent form
  • no lower extremity activity taboo, and can walk independently before admission

排除标准

  • Have neuromuscular disease.
  • Unable to step on a bed bike.

研究组 & 干预措施

exercise bike

Experimental

exercise is to use an exercise bike, start pedaling on the first day, time setting: 20 minutes, speed: 2, and adopt passive mode. If you can complete the exercise on the first day, the time will be adjusted to 30 minutes on the second day. If you cannot complete the exercise on the first day, the time will still start from 20 minutes on the second day. The maximum time is 30 minutes. If you can complete 30 minutes of passive exercise for 3 consecutive days, the fourth day will be adjusted to active exercise. The entire exercise training is seven days a week, once a day, once a 30-minute, at least 5 days. Those who were discharged to the general ward continued to complete this exercise training for up to 28 days.

干预措施: exercise bike (Other)

regular rehabilitation exercises

No Intervention

walking exercise

结局指标

主要结局

days in intensive care unit

时间窗: baseline

Health Assessment Form

body mass index

时间窗: baseline

Health Assessment Form

The daily observation record sheet includes

时间窗: up to 28 days

Vital signs,respirator is used or not,bicycle use pattern,speed and time,reasons for stopping

total days in hospital

时间窗: baseline

Health Assessment Form

days on ventilator

时间窗: baseline

Health Assessment Form

Basic Demographic Health Assessment Form

时间窗: baseline

Age, sex, diagnosis, disease severity, reason for ICU admission

level of albumin

时间窗: baseline

Health Assessment Form

次要结局

  • foot lift(28days after intervention(T7))
  • Hand grip strength(28 days after intervention(T7))
  • walking distance in 6 minutes(28ays after intervention(T7))
  • Hand grip strength(17 days after intervention(T5))
  • Hand grip strength(baseline(T0))
  • Hand grip strength(3 days after intervention(T1))
  • Hand grip strength(7 days after intervention(T2))
  • Hand grip strength(10 days after intervention(T3))
  • Hand grip strength(14 days after intervention(T4))
  • Hand grip strength(21 days after intervention(T6))
  • foot lift(baseline(T0))
  • foot lift(3 days after intervention(T1))
  • foot lift(7days after intervention(T2))
  • foot lift(10days after intervention(T3))
  • foot lift(14days after intervention(T4))
  • foot lift(17ays after intervention(T5))
  • foot lift(21days after intervention(T6))
  • walking distance in 6 minutes(baseline(T0))
  • walking distance in 6 minutes(3 days after intervention(T1))
  • walking distance in 6 minutes(7 days after intervention(T2))
  • walking distance in 6 minutes(10days after intervention(T3))
  • walking distance in 6 minutes(14days after intervention(T4))
  • walking distance in 6 minutes(17days after intervention(T5))
  • walking distance in 6 minutes(21days after intervention(T6))

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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