Rehabilitating Muscle After Intensive Care (REMAIC)

October 2, 2019 updated by: St Helens & Knowsley Teaching Hospitals NHS Trust
The study will examine the effect of amino acid supplements and enhanced physiotherapy on physical recovery following critical illness in intensive care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

93

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Manchester, United Kingdom, M13 9WL
        • Central Manchester University Hospitals NHS Foundation Trust
    • Merseyside
      • Prescot, Merseyside, United Kingdom, L35 5DR
        • St Helens & Knowsley Teaching NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ICU Recovery Manual & placebo supplement
Patients will receive the standard self-directed rehabilitation package and a placebo nutritional supplement
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
Experimental: ICU recovery manual & amino acid (AA) supplement
Patients will receive the standard self-directed rehabilitation package with the essential amino acid supplement
Other: Intensive Care Unit (ICU) Recovery Manual
Standard self-directed 6 week rehabilitation package
Dietary supplement: Amino acid supplement
Flavoured essential amino acid supplement and glutamine dipeptide taken twice daily for 3 months
Experimental: PEPSE & placebo supplement
Patients will receive the standard self-directed rehabilitation package plus PEPSE and the placebo nutritional supplement
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
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).
Experimental: PEPSE & AA supplement
Patients will receive the standard self-directed rehabilitation package plus PEPSE and the essential amino acid nutritional supplement
Other: Intensive Care Unit (ICU) Recovery Manual
Standard self-directed 6 week rehabilitation package
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement in insulin resistance between recruitment to the study and the 1 year follow-up point
Time Frame: 1 year
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
Time Frame: 1 year
1 year
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St Helens & Knowsley Teaching Hospitals NHS Trust

Collaborators

Manchester University NHS Foundation Trust

Investigators

  • Principal Investigator: Richard D Griffiths, MD, St Helens & Knowley Teaching NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

February 2, 2010

First Submitted That Met QC Criteria

February 4, 2010

First Posted (Estimate)

February 5, 2010

Study Record Updates

Last Update Posted (Actual)

October 3, 2019

Last Update Submitted That Met QC Criteria

October 2, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PB_PG_1208_18030

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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