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Completed

NCT Number: NCT01063738

Rehabilitating Muscle After Intensive Care

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

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Key information

Conditions

Recovery From Critical Illness Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

45 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Helens & Knowsley Teaching NHS Trust, Prescot, Merseyside, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amino acid supplement

Dietary Supplement

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

PEPSE

Other

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 Manual

Other

Standard self-directed 6 week rehabilitation package

Placebo nutritional supplement

Dietary Supplement

Cherry flavoured low calorie and low protein placebo drink

Primary outcomes

  1. 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

  1. Improvement in insulin resistance between recruitment to the study and the 1 year follow-up point

    Time frame: 1 year

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

St Helens & Knowsley Teaching Hospitals NHS Trust

Other

Collaborators

  • Manchester University NHS Foundation Trust

Registry information

Acronym: REMAIC

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Feb 5, 2010
Registry last updated
Oct 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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