Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
93 participants
INTERVENTIONAL
2010-08-31
2014-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ICU Recovery Manual & placebo supplement
Patients will receive the standard self-directed rehabilitation package and a placebo nutritional supplement
Intensive Care Unit (ICU) Recovery Manual
Standard self-directed 6 week rehabilitation package
Placebo nutritional supplement
Cherry flavoured low calorie and low protein placebo drink
ICU recovery manual & amino acid (AA) supplement
Patients will receive the standard self-directed rehabilitation package with the essential amino acid supplement
Amino acid supplement
Flavoured essential amino acid supplement and glutamine dipeptide taken twice daily for 3 months
Intensive Care Unit (ICU) Recovery Manual
Standard self-directed 6 week rehabilitation package
PEPSE & placebo supplement
Patients will receive the standard self-directed rehabilitation package plus PEPSE and the placebo nutritional supplement
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).
Intensive Care Unit (ICU) Recovery Manual
Standard self-directed 6 week rehabilitation package
Placebo nutritional supplement
Cherry flavoured low calorie and low protein placebo drink
PEPSE & AA supplement
Patients will receive the standard self-directed rehabilitation package plus PEPSE and the essential amino acid nutritional supplement
Amino acid supplement
Flavoured essential amino acid supplement and glutamine dipeptide taken twice daily for 3 months
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).
Intensive Care Unit (ICU) Recovery Manual
Standard self-directed 6 week rehabilitation package
Interventions
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Amino acid supplement
Flavoured essential amino acid supplement and glutamine dipeptide taken twice daily for 3 months
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).
Intensive Care Unit (ICU) Recovery Manual
Standard self-directed 6 week rehabilitation package
Placebo nutritional supplement
Cherry flavoured low calorie and low protein placebo drink
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
45 Years
99 Years
ALL
No
Sponsors
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Manchester University NHS Foundation Trust
OTHER_GOV
St Helens & Knowsley Teaching Hospitals NHS Trust
OTHER
Responsible Party
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Principal Investigators
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Richard D Griffiths, MD
Role: PRINCIPAL_INVESTIGATOR
St Helens & Knowley Teaching NHS Trust
Locations
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St Helens & Knowsley Teaching NHS Trust
Prescot, Merseyside, United Kingdom
Central Manchester University Hospitals NHS Foundation Trust
Manchester, , United Kingdom
Countries
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References
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Jones C, Eddleston J, McCairn A, Dowling S, McWilliams D, Coughlan E, Griffiths RD. Improving rehabilitation after critical illness through outpatient physiotherapy classes and essential amino acid supplement: A randomized controlled trial. J Crit Care. 2015 Oct;30(5):901-7. doi: 10.1016/j.jcrc.2015.05.002. Epub 2015 May 9.
Other Identifiers
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PB_PG_1208_18030
Identifier Type: -
Identifier Source: org_study_id
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