Recovery From Critical IllnessREMAICNCT01063738
Rehabilitating Muscle After Intensive Care
A study testing Amino acid supplement, PEPSE and Intensive Care Unit (ICU) Recovery Manual in people with Recovery From Critical Illness, run by St Helens & Knowsley Teaching Hospitals NHS Trust at 2 sites in United Kingdom.
Trial summary
The study will examine the effect of amino acid supplements and enhanced physiotherapy on physical recovery following critical illness in intensive care. Read more about this study
- Who is it for?
- Ages 45 to 99 years
- Conditions the study is for
- Recovery From Critical Illness
- What is being tested?
- Amino acid supplement, PEPSE and Intensive Care Unit (ICU) Recovery Manual
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Aug 2010to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 45 years of age and over with an intensive care stay of five days or more
Who cannot join
- Physically not capable of engaging with the practical requirements of the study
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Central Manchester University Hospitals NHS Foundation Trust
Manchester, M13 9WL
St Helens & Knowsley Teaching NHS Trust
Prescot, Merseyside, L35 5DR
About this study
The study will examine the effect of amino acid supplements and enhanced physiotherapy on physical recovery following critical illness in intensive care.
Read the 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.
- Conditions
- Recovery From Critical Illness
- Being tested
- Amino acid supplement, PEPSE, Intensive Care Unit (ICU) Recovery Manual, Placebo nutritional supplement
- Keywords
- Rehabilitation, Intensive Care, Critical illness, Physiotherapy, Nutritional supplementation
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amino acid supplementDietary supplement
Flavoured essential amino acid supplement and glutamine dipeptide taken twice daily for 3 months
PEPSEOther
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 ManualOther
Standard self-directed 6 week rehabilitation package
Placebo nutritional supplementDietary supplement
Cherry flavoured low calorie and low protein placebo drink
| Study group | Role | What they receive |
|---|---|---|
| ICU Recovery Manual & placebo supplement | Active comparator | Patients will receive the standard self-directed rehabilitation package and a placebo nutritional supplement Receives: 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 Receives: 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 Receives: 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 Receives: Dietary Supplement: Amino acid supplement; Other: PEPSE; Other: Intensive Care Unit (ICU) Recovery Manual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (3)
Improvement in insulin resistance between recruitment to the study and the 1 year follow-up point
Measured: 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
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2010 (estimated)
- Study startAug 2010
- Primary completionMar 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recovery From Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Helens & Knowsley Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Richard D Griffiths, MD, Principal investigator, St Helens & Knowley Teaching NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01063738
- Sponsor's protocol ID
- PB_PG_1208_18030
- Acronym
- REMAIC
- Status last verified
- Oct 2019
- First submitted
- 2 Feb 2010
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 26004031
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitating Muscle After Intensive Care
- ClinicalTrials.gov ID
- NCT01063738
- Acronym / sponsor ID
- REMAIC / PB_PG_1208_18030
- Conditions
- Recovery From Critical Illness
- Keywords
- Rehabilitation, Intensive Care, Critical illness, Physiotherapy, Nutritional supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- St Helens & Knowsley Teaching Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust
- Study start
- Aug 2010
- Primary completion
- Mar 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 5 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ICU Recovery Manual & placebo supplement | Active comparator | Other: Intensive Care Unit (ICU) Recovery Manual, Dietary Supplement: Placebo nutritional supplementPatients will receive the standard self-directed rehabilitation package and a placebo nutritional supplement |
| ICU recovery manual & amino acid (AA) supplement | Experimental | Dietary Supplement: Amino acid supplement, Other: Intensive Care Unit (ICU) Recovery ManualPatients will receive the standard self-directed rehabilitation package with the essential amino acid supplement |
| PEPSE & placebo supplement | Experimental | Other: PEPSE, Other: Intensive Care Unit (ICU) Recovery Manual, Dietary Supplement: Placebo nutritional supplementPatients will receive the standard self-directed rehabilitation package plus PEPSE and the placebo nutritional supplement |
| PEPSE & AA supplement | Experimental | Dietary Supplement: Amino acid supplement, Other: PEPSE, Other: Intensive Care Unit (ICU) Recovery ManualPatients will receive the standard self-directed rehabilitation package plus PEPSE and the essential amino acid nutritional supplement |
Who may qualify
- Ages
- 45 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 45 years of age and over with an intensive care stay of five days or more
Key exclusion criteria (1 listed)
- Physically not capable of engaging with the practical requirements of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amino acid supplementFlavoured essential amino acid supplement and glutamine dipeptide taken twice daily for 3 months | Dietary supplement | ICU recovery manual & amino acid (AA) supplement, PEPSE & AA supplement |
| PEPSEEnhanced 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 | PEPSE & AA supplement, PEPSE & placebo supplement |
| Intensive Care Unit (ICU) Recovery ManualStandard self-directed 6 week rehabilitation package | Other | ICU Recovery Manual & placebo supplement, ICU recovery manual & amino acid (AA) supplement, PEPSE & AA supplement, PEPSE & placebo supplement |
| Placebo nutritional supplementCherry flavoured low calorie and low protein placebo drink | Dietary supplement | ICU Recovery Manual & placebo supplement, PEPSE & placebo supplement |
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
- Derived from this study: PubMed 26004031Jones 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.
Related trials for Recovery From Critical Illness
Not yet recruitingObservational study
Analysis of Weaning of Analgosedation and Kinetics of Emergence in Critically Ill Patients
Critical Illness, Mechanical Ventilation
Not yet recruitingObservational study
Auditory Processing in DOC Patients
Disorder of Consciousness, Unresponsive Wakefulness Syndrome
RecruitingObservational study
Recovery From ICUAW Following Severe Respiratory and Cardiac Failure
Intensive Care Unit Syndrome, Intensive Care Neuropathy
Recruiting
I-WEAR: Evaluating Wearables and Health Summaries in ICU Survivors
Post-Intensive Care Syndrome (PICS), Critical Illness Recovery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard D Griffiths, MD principal investigator
St Helens & Knowley Teaching NHS Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amino acid supplement, PEPSE and Intensive Care Unit (ICU) Recovery Manual in people with Recovery From Critical Illness, run by St Helens & Knowsley Teaching Hospitals NHS Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01063738, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2019.