Rehabilitating Muscle After Intensive Care (REMAIC)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Central Manchester University Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
St Helens & Knowsley Teaching Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01063738
First received: February 2, 2010
Last updated: May 27, 2014
Last verified: April 2011
  Purpose

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


Condition Intervention
Recovery From Critical Illness
Dietary Supplement: Amino acid supplement
Other: PEPSE
Other: Intensive Care Unit (ICU) Recovery Manual
Dietary Supplement: Placebo nutritional supplement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rehabilitating Muscle After Intensive Care

Resource links provided by NLM:


Further study details as provided by St Helens & Knowsley Teaching Hospitals NHS Trust:

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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in insulin resistance between recruitment to the study and the 1 year follow-up point [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: September 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Dietary Supplement: Amino acid supplement
Flavoured essential amino acid supplement and glutamine dipeptide taken twice daily for 3 months
Other: Intensive Care Unit (ICU) Recovery Manual
Standard self-directed 6 week rehabilitation package
Experimental: PEPSE & placebo supplement
Patients will receive the standard self-directed rehabilitation package plus PEPSE and the placebo nutritional supplement
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
Experimental: PEPSE & AA supplement
Patients will receive the standard self-directed rehabilitation package plus PEPSE and the essential amino acid nutritional supplement
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

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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01063738

Locations
United Kingdom
St Helens & Knowsley Teaching NHS Trust
Prescot, Merseyside, United Kingdom, L35 5DR
Central Manchester University Hospitals NHS Foundation Trust
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
St Helens & Knowsley Teaching Hospitals NHS Trust
Central Manchester University Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Richard D Griffiths, MD St Helens & Knowley Teaching NHS Trust
  More Information

No publications provided

Responsible Party: St Helens & Knowsley Teaching Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01063738     History of Changes
Other Study ID Numbers: PB_PG_1208_18030
Study First Received: February 2, 2010
Last Updated: May 27, 2014
Health Authority: United Kingdom: National Institute for Health Research

Keywords provided by St Helens & Knowsley Teaching Hospitals NHS Trust:
Rehabilitation
Intensive Care
Critical illness
Physiotherapy
Nutritional supplementation

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014