An interventional study of Amino acid supplement and PEPSE in Recovery From Critical Illness, sponsored by St Helens & Knowsley Teaching Hospitals NHS Trust. Completed at 2 sites in United Kingdom. Open to participants aged 45 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-10-03.
Sponsored by St Helens & Knowsley Teaching Hospitals NHS Trust · Not applicable, Interventional, and Treatment
The study will examine the effect of amino acid supplements and enhanced physiotherapy on physical recovery following critical illness in intensive care.
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.
1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.
This study's enrollment of 93 is close to the median of 90 across 979 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →St Helens & Knowsley Teaching Hospitals NHS Trust is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive the standard self-directed rehabilitation package and a placebo nutritional supplement
Other: Intensive Care Unit (ICU) Recovery Manual · Dietary Supplement: Placebo nutritional supplement
Patients will receive the standard self-directed rehabilitation package with the essential amino acid supplement
Dietary Supplement: Amino acid supplement · Other: Intensive Care Unit (ICU) Recovery Manual
Patients will receive the standard self-directed rehabilitation package plus PEPSE and the placebo nutritional supplement
Other: PEPSE · Other: Intensive Care Unit (ICU) Recovery Manual · Dietary Supplement: Placebo nutritional supplement
Patients will receive the standard self-directed rehabilitation package plus PEPSE and the essential amino acid nutritional supplement
Dietary Supplement: Amino acid supplement · Other: PEPSE · Other: Intensive Care Unit (ICU) Recovery Manual
Flavoured essential amino acid supplement and glutamine dipeptide taken twice daily for 3 months
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).
Standard self-directed 6 week rehabilitation package
Cherry flavoured low calorie and low protein placebo drink
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
Time frame: 3 months
Improvement in insulin resistance between recruitment to the study and the 1 year follow-up point
Time frame: 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
Time frame: 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
Time frame: 1 year
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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St Helens & Knowsley Teaching Hospitals NHS Trust