跳至主要内容
临床试验/NCT02491021
NCT02491021已完成2 期

Outpatient Based Physical Rehabilitation for Survivors of Prolonged Critical Illness - a Randomised Controlled Trial

University Hospital Birmingham NHS Foundation Trust0 个研究点目标入组 63 人开始时间: 2007年10月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
63
主要终点
Cardiopulmonary Exercise Testing

研究概览

简要总结

Admission to an intensive care unit (ICU) due to illness has been shown to have a dramatic effect on the human body and mind. Following discharge from an ICU, patients suffer from varying degrees of weakness and muscle wasting. It can take many months before their strength returns to something like before they were ill. This weakness can have important consequences on an individual, affecting their ability to perform routine tasks (e.g. housework, shopping), and whether they can return to work or not. Not surprisingly, this inability to perform activities they used to do prior to their illness can have knock on effects on their mental well being and confidence.

What the investigators hope to see through this study is whether or not patients can recover their ability to perform exercise more quickly following an ICU admission if they undergo an exercise-based rehabilitation programme. The investigators also hope to see whether taking part in a rehabilitation programme has any affect on physical and mental well being.

The investigators hope to use a simple exercise test on a bicycle to assess subjects ability to exercise shortly after leaving hospital. We will then repeat the test after a period of physiotherapy lead rehabilitation to see if they have received any benefit from the programme. The investigators hope to show that by undergoing an exercise-based rehabilitation programme subjects will recover their ability to exercise more quickly than those who do not.

By means of questionnaires the investigators hope to see what effect the rehabilitation programme has had on participants physical and mental well being.

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
Single (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

入选标准

  • All patients over the age of 18
  • admitted to a single, tertiary centre United Kingdom general intensive care unit (ICU)
  • Invasively ventilated ≥ 5 days

排除标准

  • Physical condition resulting in an inability to perform a cardio-pulmonary exercise test (CPET) or to participate in the rehabilitation classes,
  • Psychiatric condition or impairment not allowing informed consent or compliance with the rehabilitation programme,
  • Participation in an alternative rehabilitation programme,
  • Terminal illness
  • Poorly controlled cardio-respiratory disease

结局指标

主要结局

Cardiopulmonary Exercise Testing

时间窗: At recruitment (within 6 weeks of hospital discharge) and then reassessed 8-10 weeks later

Primary outcome was the change in exercise capacity measured by changes in peak VO2 and anaerobic threshold (AT) assessed using cardio-pulmonary exercise testing (CPET).

次要结局

  • Short Form 36 Health Questionnaire(At recruitment (within 6 weeks of hospital discharge) and then reassessed 8-10 weeks later)

研究者

发起方
University Hospital Birmingham NHS Foundation Trust
申办方类型
Other
责任方
Principal Investigator
主要研究者

David McWilliams

Mr David McWilliams

University Hospital Birmingham NHS Foundation Trust

相似试验