Rehabilitating Muscle After Intensive Care

Recovery From Critical Illness Clinical Trial

— REMAIC  

Official title:

Rehabilitating Muscle After Intensive Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01063738
• Other study ID #: PB_PG_1208_18030
• Status: Completed
• Phase: N/A
• Start date: August 2010
• Est. completion date: November 2014

Study information

• Verified date: October 2019
• Source: St Helens & Knowsley Teaching Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: November 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Recovery From Critical Illness

Intervention

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).
• 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

Locations

Country	Name	City	State
United Kingdom	Central Manchester University Hospitals NHS Foundation Trust	Manchester
United Kingdom	St Helens & Knowsley Teaching NHS Trust	Prescot	Merseyside

Sponsors (2)

Lead Sponsor	Collaborator
St Helens & Knowsley Teaching Hospitals NHS Trust	Manchester University NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Improvement in insulin resistance between recruitment to the study and the 1 year follow-up point		1 year
Secondary	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
Secondary	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