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Rehabilitating Muscle After Intensive Care (REMAIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01063738
Recruitment Status : Completed
First Posted : February 5, 2010
Last Update Posted : October 3, 2019
Sponsor:
Collaborator:
Manchester University NHS Foundation Trust
Information provided by (Responsible Party):
St Helens & Knowsley Teaching Hospitals NHS Trust

Tracking Information
First Submitted Date  ICMJE February 2, 2010
First Posted Date  ICMJE February 5, 2010
Last Update Posted Date October 3, 2019
Study Start Date  ICMJE August 2010
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2010)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2010)
  • Improvement in insulin resistance between recruitment to the study and the 1 year follow-up point [ Time Frame: 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2010)
  • Improvement in insulin resistance between recruitment to the study and the 1 year follow-up point [ Time Frame: 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 ]
  • Increase in muscle mass and bone density assessed using DEXA scanning between recruitment to the study and the 1 year follow-up point [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rehabilitating Muscle After Intensive Care
Official Title  ICMJE Rehabilitating Muscle After Intensive Care
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Recovery From Critical Illness
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: ICU Recovery Manual & placebo supplement
    Patients will receive the standard self-directed rehabilitation package and a placebo nutritional supplement
    Interventions:
    • Other: Intensive Care Unit (ICU) Recovery Manual
    • Dietary Supplement: Placebo nutritional supplement
  • Experimental: ICU recovery manual & amino acid (AA) supplement
    Patients will receive the standard self-directed rehabilitation package with the essential amino acid supplement
    Interventions:
    • Dietary Supplement: Amino acid supplement
    • Other: Intensive Care Unit (ICU) Recovery Manual
  • Experimental: PEPSE & placebo supplement
    Patients will receive the standard self-directed rehabilitation package plus PEPSE and the placebo nutritional supplement
    Interventions:
    • Other: PEPSE
    • Other: Intensive Care Unit (ICU) Recovery Manual
    • Dietary Supplement: Placebo nutritional supplement
  • Experimental: PEPSE & AA supplement
    Patients will receive the standard self-directed rehabilitation package plus PEPSE and the essential amino acid nutritional supplement
    Interventions:
    • Dietary Supplement: Amino acid supplement
    • Other: PEPSE
    • Other: Intensive Care Unit (ICU) Recovery Manual
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 2, 2015)
93
Original Estimated Enrollment  ICMJE
 (submitted: February 4, 2010)
180
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01063738
Other Study ID Numbers  ICMJE PB_PG_1208_18030
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party St Helens & Knowsley Teaching Hospitals NHS Trust
Original Responsible Party Professor Richard David Griffiths, Whiston Hospital
Current Study Sponsor  ICMJE St Helens & Knowsley Teaching Hospitals NHS Trust
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Manchester University NHS Foundation Trust
Investigators  ICMJE
Principal Investigator: Richard D Griffiths, MD St Helens & Knowley Teaching NHS Trust
PRS Account St Helens & Knowsley Teaching Hospitals NHS Trust
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP