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Trial registered on ANZCTR


Trial ID
ACTRN12612000528853
Ethics application status
Approved
Date submitted
17/05/2012
Date registered
18/05/2012
Date last updated
17/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
eRiCC trial: Early rehabilitation in Critical Care
Scientific title
Functional electrical stimulation assisted cycling to prevent muscle weakness in intensive care: pilot randomised controlled trial
Secondary ID [1] 280504 0
Nil
Universal Trial Number (UTN)
U1111-1130-8618
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intensive care Unit acquired weakness 286481 0
Sepsis 286482 0
Condition category
Condition code
Physical Medicine / Rehabilitation 286742 286742 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Arm:
Timeframe: Within 72 hours of ICU admission until ICU discharge

Program: In addition to standard care physiotherapy, individuals within the intervention arm of the trial will undergo up to one hour of supine cycling daily with the aim of training at least five times per week using a cycle ergometer (RT300 supine model Restorative Therapies, Ltd., Baltimore, United States) attached to a six channel stimulator (SAGE stimulator, Restorative Therapies Ltd., Baltimore, United States) and two additional RT50 wireless stimulator channels.

Within the intervention arm it is a single legged design with one leg undergoing cycling alone without the electrodes turned on (sham) and the other leg undergoing cycling and muscle stimulation. Electrodes will be placed on all the major lower limb muscles. The intervention will be provided on an individual basis and supervised by a trained physiotherapist.

Duration and Intensity: Up to 1 hour aiming for at least 5 times a week. The intensity of muscle stimulation will be delivered at a level able to cause visible muscle contractions in all muscle groups and will be confirmed by palpation.
Intervention code [1] 284869 0
Rehabilitation
Comparator / control treatment
Both groups will receive usual medical and nursing care in the ICU and ward. Both groups (control and intervention) will receive standard care physiotherapy including respiratory and rehabilitation with mobilisation activities such as sitting out of bed, marching on the spot, and mobility training. The standard care physiotherapy will be provided for up to 15 minutes in total per day.

A subgroup of 20 individuals (10 from the intervention arm and 10 from the control arm of the trial) will be involved in biomarker analyses. This will involve collection of muscle biopsy, blood and urine analyses at baseline and ICU discharge.
Control group
Active

Outcomes
Primary outcome [1] 287135 0
Muscle mass and cross sectional area

Bioimpedance Spectroscopy will be used to evaluate changes in muscle mass. Ultrasonography of the quadriceps will assess changes in muscle thickness and cross sectional area
Timepoint [1] 287135 0
Baseline and then weekly until ICU discharge, ICU discharge, acute hospital discharge
Primary outcome [2] 287136 0
Muscle Strength

This will be assessed using the Medical Research Council Scale for identifying muscle weakness in ICU and also hand-held dynamometry for grip strength and isometric quadriceps strength
Timepoint [2] 287136 0
Baseline, weekly until ICU discharge, ICU Discharge, acute hospital discharge
Primary outcome [3] 287137 0
Physical Function

This will be assessed using the PFIT (Physical Function Independence Test) and FSS-ICU (Functional Status Score in intensive care). The 6-MWT (six-minute walk test) will be evaluated only at acute hospital discharge
Timepoint [3] 287137 0
PFIT and FSS-ICU: baseline, weekly in ICU, ICU discharge
6-MWT: acute hospital discharge
Secondary outcome [1] 297460 0
Biomarker analyses (muscle biopsy, 24 hour urine collection and blood analyses) in subgroup of n=20 from main pilot RCT
Timepoint [1] 297460 0
Baseline and ICU discharge
Secondary outcome [2] 297461 0
Hours of mechanical ventilation, ICU hours and ICU readmission

This will be collected from medical records data.
Timepoint [2] 297461 0
This will all be reported at the completion of the trial

Eligibility
Key inclusion criteria
Individuals expected to be mechanically ventilated for > 48 hours with diagnosis of sepsis or severe sepsis as defined by ACCP Consensus Conference criteria and predicted to remain in ICU for 4 days or more.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if:
1. Known primary systemic neuromuscular disease or intracranial process on ICU admission
2. Lower limb amputation/s
3. Unable to perform study physical outcome measures pre morbidly due to condition impairing mobility
4. assessed by medical staff as approaching imminent death or withdrawal of medical treatment within 36 hours
5. Pregnancy
6. BMI > 40
7. Presence of external fixator or superficial metal in lower limb
8. open wounds or skin abrasions at electrode application points
9. presence of pacemaker or implanted defibrillator
10. transferred from another ICU after > 2 days of mechanical ventilation
11. platelets < 40 000 and INR > 1.6 (for muscle biopsy)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelope with sequence concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Offsite research personnel not involved in the trial will generate a computer generated random numbers table for randomisation to either intervention or control arm of the trial as well as leg allocation within the intervention arm for either cycling alone or cycling with stimulation. Concealed allocation will be performed using sequentially numbered opaque sealed envelopes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285261 0
Charities/Societies/Foundations
Name [1] 285261 0
Intensive Care Foundation
Address [1] 285261 0
Level 2 Levers Terrace
Carlton Victoria 3053 Australia
Country [1] 285261 0
Australia
Funding source category [2] 285262 0
Hospital
Name [2] 285262 0
Austin Medical Research Foundation
Address [2] 285262 0
Austin Hospital - AMRF
Level 8 Harold Stokes Building
145 Studley Road
Heidelberg Victoria 3084 Australia
Country [2] 285262 0
Australia
Funding source category [3] 285263 0
Charities/Societies/Foundations
Name [3] 285263 0
Society of Critical Care Medicine - Vision Grant
Address [3] 285263 0
Society of Critical Care Medicine Headquarters
500 Midway Drive
Mount Prospect, Illinois 60056 USA
Country [3] 285263 0
United States of America
Primary sponsor type
Individual
Name
Selina Parry
Address
The University of Melbourne
School of Physiotherapy
Level 1 200 Berkeley Street
Parkville VIC 3010 Australia
Country
Australia
Secondary sponsor category [1] 284121 0
Individual
Name [1] 284121 0
Associate Professor Linda Denehy
Address [1] 284121 0
The University of Melbourne
School of Physiotherapy
Level 1 200 Berkeley Street
Parkville VIC 3010 Australia
Country [1] 284121 0
Australia
Secondary sponsor category [2] 284122 0
Individual
Name [2] 284122 0
Dr Sue Berney
Address [2] 284122 0
Austin Health
Physiotherapy Department
Level 3 Harold Stokes Building
145 Studley Road
Heidelberg Vic 3084 Australia
Country [2] 284122 0
Australia
Secondary sponsor category [3] 284123 0
Individual
Name [3] 284123 0
Dr Stephen Warrillow
Address [3] 284123 0
C/O Intensive Care Unit
Level 2 Austin Tower
Austin Health
145 Studley Road
Heidelberg Vic 3084
Country [3] 284123 0
Australia
Secondary sponsor category [4] 284124 0
Individual
Name [4] 284124 0
Dr Rene Koopman
Address [4] 284124 0
The University of Melbourne
Department of Physiology N501
Parkville VIC 3010 Australia
Country [4] 284124 0
Australia
Secondary sponsor category [5] 284125 0
Individual
Name [5] 284125 0
Dr Adam Bryant
Address [5] 284125 0
The University of Melbourne
Physiotherapy School
Level 1 200 Berkeley Street
Parkville Vic 3010 Australia
Country [5] 284125 0
Australia
Secondary sponsor category [6] 284126 0
Individual
Name [6] 284126 0
Dr Doa El-Ansary
Address [6] 284126 0
The University of Melbourne
Physiotherapy School
Level 1 200 Berkeley Street
Parkville Vic 3010 Australia
Country [6] 284126 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287278 0
Austin Health
Ethics committee address [1] 287278 0
Ethics committee country [1] 287278 0
Australia
Date submitted for ethics approval [1] 287278 0
Approval date [1] 287278 0
10/08/2011
Ethics approval number [1] 287278 0
04338

Summary
Brief summary
Intensive care acquired weakness is a common problem following an ICU admission and leads to significant impairment in physical function and strength which is most prevalent in individuals affected with sepsis. Muscle mass reductions occur rapidly with up to 20% lost within the first week alone, this is accelerated in sepsis with greater muscle protein degradation. Whilst early rehabilitation commonly involving mobilisation has been shown to be both feasible and safe, it often is delayed in commencement as it relies on the individual being alert and able to participate in therapy. This trial involves the use of an intervention which can commence early in the ICU admission to try to minimise the muscle changes that occur without the direct need for patient participation and engagement.

This trial will examine the effectiveness of functional electrical stimulation assisted cycling using a supine cycling machine and cycling alone compared to standard care in individuals with sepsis within the intensive care unit.

Within a subgroup of 20 individuals biomarker analyses will be performed to try to understand the cellular and molecular mechanisms responsible for the changes observed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34188 0
Address 34188 0
Country 34188 0
Phone 34188 0
Fax 34188 0
Email 34188 0
Contact person for public queries
Name 17435 0
Miss Selina M Parry
Address 17435 0
The University of Melbourne
School of Physiotherapy
Level 1 200 Berkeley Street
Parkville VIC 3010 Australia
Country 17435 0
Australia
Phone 17435 0
+61 3 8344 4171
Fax 17435 0
+61 3 8344 4188
Email 17435 0
selina.parry@austin.org.au
Contact person for scientific queries
Name 8363 0
Miss Selina M Parry
Address 8363 0
The University of Melbourne
School of Physiotherapy
Level 1 200 Berkeley Street
Parkville VIC 3010 Australia
Country 8363 0
Australia
Phone 8363 0
+61 3 8344 4171
Fax 8363 0
+61 3 8344 4188
Email 8363 0
selina.parry@austin.org.au