Skip to main content
OpenTrials
Completed

NCT Number: NCT02491021

Outpatient Based Physical Rehabilitation for Survivors of Prolonged Critical Illness

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All patients over the age of 18

  • admitted to a single, tertiary centre United Kingdom general intensive care unit (ICU)
  • Invasively ventilated ≥ 5 days

Exclusion criteria

  • 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

Treatment and study plan

Rehabilitation Class

Other

A 6 week programme of exercise and education in an out patient setting

Primary outcomes

  1. Cardiopulmonary Exercise Testing

    Time frame: 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).

Secondary outcomes

  1. Short Form 36 Health Questionnaire

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

    Secondary outcome measures were changes in health related Quality of life (QoL). assessed using the Medical Outcome Study Short Form-36 questionnaire Version 2 (SF36v2). Subjects were asked to answer questions based on a 2-week recall period.

Sponsors and collaborators

Lead sponsor

University Hospital Birmingham NHS Foundation Trust

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
First posted
Jul 7, 2015
Registry last updated
Jul 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.