Rehabilitating Muscle After Intensive Care

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

Detailed Description
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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.

Official Title
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Rehabilitating Muscle After Intensive Care

Conditions
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Recovery From Critical Illness

Intervention / Treatment
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* Dietary Supplement: Amino acid supplement
* Other: PEPSE
* Other: Intensive Care Unit (ICU) Recovery Manual
* Dietary Supplement: Placebo nutritional supplement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation, Intensive Care, Critical illness, Physiotherapy, Nutritional supplementation