Rehabilitating Muscle After Intensive Care

Not Applicable

Completed

• Conditions: Recovery From Critical Illness

• Registration Number: NCT01063738
• Lead Sponsor: St Helens & Knowsley Teaching Hospitals NHS Trust

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2010-02-02
• Study First Submitted QC: 2010-02-04
• Study First Posted: 2010-02-05
• Study Start: 2010-08
• Primary Completion: 2014-03
• Study Completion: 2014-11
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-02
• Last Update Posted: 2019-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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	3 months

Secondary Outcome Measures

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

Trial Locations

Locations (2)

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

Central Manchester University Hospitals NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom