Rehabilitating Muscle After Intensive Care

NCT ID: NCT01063738

Last Updated: 2019-10-03

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2014-11-30

Brief Summary

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

Detailed Description

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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

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Recovery From Critical Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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

Group Type ACTIVE_COMPARATOR

Intensive Care Unit (ICU) Recovery Manual

Intervention Type OTHER

Standard self-directed 6 week rehabilitation package

Placebo nutritional supplement

Intervention Type DIETARY_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

Group Type EXPERIMENTAL

Amino acid supplement

Intervention Type DIETARY_SUPPLEMENT

Flavoured essential amino acid supplement and glutamine dipeptide taken twice daily for 3 months

Intensive Care Unit (ICU) Recovery Manual

Intervention Type OTHER

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

Group Type EXPERIMENTAL

PEPSE

Intervention Type OTHER

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

Intervention Type OTHER

Standard self-directed 6 week rehabilitation package

Placebo nutritional supplement

Intervention Type DIETARY_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

Group Type EXPERIMENTAL

Amino acid supplement

Intervention Type DIETARY_SUPPLEMENT

Flavoured essential amino acid supplement and glutamine dipeptide taken twice daily for 3 months

PEPSE

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type DIETARY_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).

Intervention Type OTHER

Intensive Care Unit (ICU) Recovery Manual

Standard self-directed 6 week rehabilitation package

Intervention Type OTHER

Placebo nutritional supplement

Cherry flavoured low calorie and low protein placebo drink

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Manchester University NHS Foundation Trust

OTHER_GOV

Sponsor Role collaborator

St Helens & Knowsley Teaching Hospitals NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Central Manchester University Hospitals NHS Foundation Trust

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

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.

Reference Type DERIVED
PMID: 26004031 (View on PubMed)

Other Identifiers

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PB_PG_1208_18030

Identifier Type: -

Identifier Source: org_study_id

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