NCT01063738

Rehabilitating Muscle After Intensive Care

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: St Helens & Knowsley Teaching Hospitals NHS Trust · Academic / Other
• Sex: All
• Age: 45 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recovery From Critical Illness

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Amino acid supplement	Flavoured essential amino acid supplement and glutamine dipeptide taken twice daily for 3 months
OTHER	PEPSE	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).
OTHER	Intensive Care Unit (ICU) Recovery Manual	Standard self-directed 6 week rehabilitation package
DIETARY_SUPPLEMENT	Placebo nutritional supplement	Cherry flavoured low calorie and low protein placebo drink

Timeline

• Start date: 2010-08-01
• Primary completion: 2014-03-01
• Completion: 2014-11-01
• First posted: 2010-02-05
• Last updated: 2019-10-03

Locations

2 sites across 1 country: United Kingdom