Rehabilitating Muscle After Intensive Care

NCT01063738 | Completed

• 1 other identifier: PB_PG_1208_18030
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Recovery From Critical Illness

Keywords

Rehabilitation; Intensive Care; Critical illness; Physiotherapy; Nutritional supplementation

Outcome Measures

Primary Outcomes (1)

• 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

  3 months

Secondary Outcomes (3)

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

  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

  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

  1 year

Study Arms (4)

ICU Recovery Manual & placebo supplement

ACTIVE COMPARATOR

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

Other: Intensive Care Unit (ICU) Recovery Manual; Dietary Supplement: Placebo nutritional supplement

ICU recovery manual & amino acid (AA) supplement

EXPERIMENTAL

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

Dietary Supplement: Amino acid supplement; Other: Intensive Care Unit (ICU) Recovery Manual

PEPSE & placebo supplement

EXPERIMENTAL

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

Other: PEPSE; Other: Intensive Care Unit (ICU) Recovery Manual; Dietary Supplement: Placebo nutritional supplement

PEPSE & AA supplement

EXPERIMENTAL

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

Dietary Supplement: Amino acid supplement; Other: PEPSE; Other: Intensive Care Unit (ICU) Recovery Manual

Interventions

Amino acid supplement DIETARY_SUPPLEMENT

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

ICU recovery manual & amino acid (AA) supplement; PEPSE & AA supplement

PEPSE 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).

PEPSE & AA supplement; PEPSE & placebo supplement

Intensive Care Unit (ICU) Recovery Manual OTHER

Standard self-directed 6 week rehabilitation package

ICU Recovery Manual & placebo supplement; ICU recovery manual & amino acid (AA) supplement; PEPSE & AA supplement; PEPSE & placebo supplement

Placebo nutritional supplement DIETARY_SUPPLEMENT

Cherry flavoured low calorie and low protein placebo drink

ICU Recovery Manual & placebo supplement; PEPSE & placebo supplement

Eligibility Criteria

• Age: 45 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age and over with an intensive care stay of five days or more

You may not qualify if:

• Physically not capable of engaging with the practical requirements of the study

Sponsors & Collaborators

• St Helens & Knowsley Teaching Hospitals NHS Trust: lead
• Manchester University NHS Foundation Trust: collaborator

Study Sites (2)

St Helens & Knowsley Teaching NHS Trust

Prescot, Merseyside, L35 5DR, United Kingdom

Location

Central Manchester University Hospitals NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 26004031 DERIVED

MeSH Terms

Conditions

Critical Illness

Interventions

Intensive Care Units

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hospital Units; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Richard D Griffiths, MD

  St Helens & Knowley Teaching NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2010
• First Posted: February 5, 2010
• Study Start: August 1, 2010
• Primary Completion: March 1, 2014
• Study Completion: November 1, 2014
• Last Updated: October 3, 2019

Record last verified: 2019-10

Locations

GB (2)