Rehabilitating Muscle After Intensive Care (REMAIC)

St Helens & Knowsley Teaching Hospitals NHS Trust

Status: Completed

Conditions: Recovery From Critical Illness

Treatments: Other: Intensive Care Unit (ICU) Recovery Manual; Dietary Supplement: Amino acid supplement; Dietary Supplement: Placebo nutritional supplement; Other: PEPSE

Study type: Interventional

Funder types: Other

Identifiers

NCT01063738

PB_PG_1208_18030

Details and patient eligibility

About

The study will examine the effect of amino acid supplements and enhanced physiotherapy on physical recovery following critical illness in intensive care.

Full 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.

Enrollment: 93 patients

Sex: All

Ages: 45 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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93 participants in 4 patient groups

ICU Recovery Manual & placebo supplement

Active Comparator group

Description:

Patients will receive the standard self-directed rehabilitation package and a placebo nutritional supplement

Treatment:

Dietary Supplement: Placebo nutritional supplement

Other: Intensive Care Unit (ICU) Recovery Manual

ICU recovery manual & amino acid (AA) supplement

Experimental group

Description:

Patients will receive the standard self-directed rehabilitation package with the essential amino acid supplement

Treatment:

Dietary Supplement: Amino acid supplement

Other: Intensive Care Unit (ICU) Recovery Manual

PEPSE & placebo supplement

Experimental group

Description:

Patients will receive the standard self-directed rehabilitation package plus PEPSE and the placebo nutritional supplement

Treatment:

Dietary Supplement: Placebo nutritional supplement

Other: PEPSE

Other: Intensive Care Unit (ICU) Recovery Manual

PEPSE & AA supplement

Experimental group

Description:

Patients will receive the standard self-directed rehabilitation package plus PEPSE and the essential amino acid nutritional supplement

Treatment:

Other: PEPSE

Dietary Supplement: Amino acid supplement

Other: Intensive Care Unit (ICU) Recovery Manual