Rehabilitating Muscle After Intensive Care

St Helens & Knowsley Teaching Hospitals NHS Trust93 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Recovery From Critical Illness

Interventions

Amino acid supplementDIETARY_SUPPLEMENT

Flavoured essential amino acid supplement and glutamine dipeptide taken twice daily for 3 months

PEPSEOTHER

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).

Intensive Care Unit (ICU) Recovery ManualOTHER

Standard self-directed 6 week rehabilitation package

Eligibility

Sex: ALLMin age: 45 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (2)

St Helens & Knowsley Teaching NHS Trust

Prescot, Merseyside, United Kingdom

Central Manchester University Hospitals NHS Foundation Trust

Manchester, United Kingdom

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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