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Rehabilitating Muscle After Intensive Care (REMAIC)

Primary Purpose

Recovery From Critical Illness

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Amino acid supplement
PEPSE
Intensive Care Unit (ICU) Recovery Manual
Placebo nutritional supplement
Sponsored by
St Helens & Knowsley Teaching Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recovery From Critical Illness focused on measuring Rehabilitation, Intensive Care, Critical illness, Physiotherapy, Nutritional supplementation

Eligibility Criteria

45 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St Helens & Knowsley Teaching NHS Trust
  • Central Manchester University Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

ICU Recovery Manual & placebo supplement

ICU recovery manual & amino acid (AA) supplement

PEPSE & placebo supplement

PEPSE & AA supplement

Arm Description

Patients will receive the standard self-directed rehabilitation package and a placebo nutritional supplement

Patients will receive the standard self-directed rehabilitation package with the essential amino acid supplement

Patients will receive the standard self-directed rehabilitation package plus PEPSE and the placebo nutritional supplement

Patients will receive the standard self-directed rehabilitation package plus PEPSE and the essential amino acid nutritional supplement

Outcomes

Primary Outcome Measures

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 Measures

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

Full Information

First Posted
February 2, 2010
Last Updated
October 2, 2019
Sponsor
St Helens & Knowsley Teaching Hospitals NHS Trust
Collaborators
Manchester University NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01063738
Brief Title
Rehabilitating Muscle After Intensive Care
Acronym
REMAIC
Official Title
Rehabilitating Muscle After Intensive Care
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St Helens & Knowsley Teaching Hospitals NHS Trust
Collaborators
Manchester University NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recovery From Critical Illness
Keywords
Rehabilitation, Intensive Care, Critical illness, Physiotherapy, Nutritional supplementation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ICU Recovery Manual & placebo supplement
Arm Type
Active Comparator
Arm Description
Patients will receive the standard self-directed rehabilitation package and a placebo nutritional supplement
Arm Title
ICU recovery manual & amino acid (AA) supplement
Arm Type
Experimental
Arm Description
Patients will receive the standard self-directed rehabilitation package with the essential amino acid supplement
Arm Title
PEPSE & placebo supplement
Arm Type
Experimental
Arm Description
Patients will receive the standard self-directed rehabilitation package plus PEPSE and the placebo nutritional supplement
Arm Title
PEPSE & AA supplement
Arm Type
Experimental
Arm Description
Patients will receive the standard self-directed rehabilitation package plus PEPSE and the essential amino acid nutritional supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Amino acid supplement
Intervention Description
Flavoured essential amino acid supplement and glutamine dipeptide taken twice daily for 3 months
Intervention Type
Other
Intervention Name(s)
PEPSE
Intervention Description
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
Intervention Name(s)
Intensive Care Unit (ICU) Recovery Manual
Intervention Description
Standard self-directed 6 week rehabilitation package
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo nutritional supplement
Intervention Description
Cherry flavoured low calorie and low protein placebo drink
Primary Outcome Measure Information:
Title
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Improvement in insulin resistance between recruitment to the study and the 1 year follow-up point
Time Frame
1 year
Title
Improvement in patients perception of their health related quality of life between recruitment to the study and the 1 year follow-up point
Time Frame
1 year
Title
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
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard D Griffiths, MD
Organizational Affiliation
St Helens & Knowley Teaching NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Helens & Knowsley Teaching NHS Trust
City
Prescot
State/Province
Merseyside
ZIP/Postal Code
L35 5DR
Country
United Kingdom
Facility Name
Central Manchester University Hospitals NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26004031
Citation
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.
Results Reference
derived

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Rehabilitating Muscle After Intensive Care

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