Clinical trial NCT01063738: Rehabilitating Muscle After Intensive Care
Official title: Rehabilitating Muscle After Intensive Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recovery From Critical Illness
Keywords: Rehabilitation
Intensive Care
Critical illness
Physiotherapy
Nutritional supplementation
Lead sponsor: St Helens & Knowsley Teaching Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: Manchester University NHS Foundation Trust
First posted: 2010-02-05
Enrollment: 93
Sex: ALL
Minimum age (years): 45
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 3 months
Secondary outcomes:
measure: Improvement in insulin resistance between recruitment to the study and the 1 year follow-up point
timeFrame: 1 year
measure: Improvement in patients perception of their health related quality of life between recruitment to the study and the 1 year follow-up point
timeFrame: 1 year
measure: 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
timeFrame: 1 year
Other outcomes:
Locations:
city: Prescot
country: United Kingdom
facility: St Helens & Knowsley Teaching NHS Trust
state: Merseyside
city: Manchester
country: United Kingdom
facility: Central Manchester University Hospitals NHS Foundation Trust
Study officials:
affiliation: St Helens & Knowley Teaching NHS Trust
name: Richard D Griffiths, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jones C, Eddleston J, McCairn A, Dowling S, McWilliams D, Coughlan E, Griffiths RD. Improving rehabilitation after critical illness through outpatient physiotherapy classes and essential amino acid supplement: A randomized controlled trial. J Crit Care. 2015 Oct;30(5):901-7. doi: 10.1016/j.jcrc.2015.05.002. Epub 2015 May 9.