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 pointImprovement 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
|