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Rehabilitating Muscle After Intensive Care

Information source: St Helens & Knowsley Teaching Hospitals NHS Trust
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Recovery From Critical Illness

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

Phase: N/A

Status: Completed

Sponsored by: St Helens & Knowsley Teaching Hospitals NHS Trust

Official(s) and/or principal investigator(s):
Richard D Griffiths, MD, Principal Investigator, Affiliation: St Helens & Knowley Teaching NHS Trust

Summary

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

Clinical Details

Official title: Rehabilitating Muscle After Intensive Care

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: 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

Secondary outcome:

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

Improvement in patients perception of their health related quality of life between recruitment to the study and the 1 year follow-up point

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

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

Minimum age: 45 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Central Manchester University Hospitals NHS Foundation Trust, Manchester M13 9WL, United Kingdom

St Helens & Knowsley Teaching NHS Trust, Prescot, Merseyside L35 5DR, United Kingdom

Additional Information

Starting date: August 2010
Last updated: January 2, 2015

Page last updated: August 23, 2015

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