Recovery From Critical Illness
Conditions
Keywords
Rehabilitation, Intensive Care, Critical illness, Physiotherapy, Nutritional supplementation
Brief summary
The study will examine the effect of amino acid supplements and enhanced physiotherapy on physical recovery following critical illness in intensive care.
Detailed description
Critically ill patients aged 45 years and over will be recruited during recovery after intensive care. Using a randomised controlled, blind at follow-up design the study will examine whether the combination of an amino acid supplement and an enhanced physiotherapy programme improve the rehabilitation of muscle following intensive care better than a self-guided rehabilitation programme alone or with either an amino acid supplement or the enhanced physiotherapy programme. The Primary efficacy outcome will be the improvement in six minute walking test measured at 3 months post intensive care discharge. Secondary efficacy parameters will be insulin resistance, health related quality of life and muscle mass using DEXA scanning at 3 months and 1 year post intensive care discharge.
Interventions
DIETARY_SUPPLEMENTAmino acid supplement
Flavoured essential amino acid supplement and glutamine dipeptide taken twice daily for 3 months
OTHERPEPSE
Enhanced physiotherapy programme of 3 1 hour sessions per week for 6 weeks while in hospital and once discharged home 1 supervised outpatient session of 1 hour and 2 home exercise sessions per week (PEPSE).
OTHERIntensive Care Unit (ICU) Recovery Manual
Standard self-directed 6 week rehabilitation package
DIETARY_SUPPLEMENTPlacebo nutritional supplement
Cherry flavoured low calorie and low protein placebo drink
Sponsors
Manchester University NHS Foundation Trust
St Helens & Knowsley Teaching Hospitals NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* 45 years of age and over with an intensive care stay of five days or more
Exclusion criteria
* Physically not capable of engaging with the practical requirements of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in the distance walked by patients in 6 minutes (6 minute walk test) between recruitment to the study and 3 months post intensive care discharge | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in insulin resistance between recruitment to the study and the 1 year follow-up point | 1 year |
| Improvement in patients perception of their health related quality of life between recruitment to the study and the 1 year follow-up point | 1 year |
| Increase in muscle mass and bone density assessed using dual energy x-ray absorptiometry (DEXA) scanning between recruitment to the study and the 1 year follow-up point | 1 year |
Countries
United Kingdom
Outcome results
None listed