Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000808044
Ethics application status
Approved
Date submitted
22/09/2010
Date registered
27/09/2010
Date last updated
24/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving Outcomes in Critical Illness with Early Rehabilitation
Scientific title
Mobilising Critically Ill patients:
Physiological and Functional Outcomes following Early Rehabilitation in Sepsis
Secondary ID [1] 252737 0
NIL
Universal Trial Number (UTN)
Trial acronym
i-PERFORM Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sepsis 258237 0
Intensive Care Unit Acquired Weakness 258274 0
Condition category
Condition code
Physical Medicine / Rehabilitation 258416 258416 0 0
Physiotherapy
Musculoskeletal 258465 258465 0 0
Other muscular and skeletal disorders
Infection 258466 258466 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Arm:
Adminster Rehabiliation package ( targeted exercises)
by physiotherapist in the intensive care unit (ICU).

The intervention group will receive an early, specific, targeted rehabilitation program involving electrical muscle stimulation, passive and active range of motion exercises, mobilisation out of bed, tilt-table therapy, arm and leg ergometry exercises and ambulation.

Commencement: 48hrs following Mechanical Ventilation
Duration and Frequency: 30 mins x 1-2 day
Overall duration: From recruitment till ICU discharge
Mode of adminstration: Individual exercise prescription by a physiotherapist
Intervention code [1] 257254 0
Rehabilitation
Comparator / control treatment
Control Arm:
Usual care

The control group will receive usual care from the ICU staff i.e. sitting out of bed and walking.


Commencement: Anytime during ICU stay after recruitment.
Duration and Frequency: As prescribed by ICU staff.
Overall duration: From recruitment till ICU discharge.
Mode of adminstration: As per usual care by ICU staff.
Control group
Active

Outcomes
Primary outcome [1] 259264 0
Acute Care Index of Function
(ACIF)

ACIF will assess physical functional performance
Timepoint [1] 259264 0
Baseline and at ICU Discharge
Primary outcome [2] 259265 0
Short Form 36 Medical Study
(SF-36)

SF-36 will assess quality of life
Timepoint [2] 259265 0
Baseline and at ICU Discharge
Primary outcome [3] 259266 0
Hospital Anxiety Depression Scale
(HADS)

HADS will assess psychological components
Timepoint [3] 259266 0
Baseline and at ICU Discharge
Secondary outcome [1] 265664 0
Physical Function ICU Test
(PFIT)

PFIT will assess physical functional exercise capacity
Timepoint [1] 265664 0
Baseline and at ICU discharge and 6 month follow up
Secondary outcome [2] 265665 0
Blood Assays for Inflammatory Biomarkers :
Interleukin 6 (IL 6), Interleukin 10(IL 10), Tumor Necrosis Factor aplha) (TNF alpha)

Blood assays will assess levels of anti-inflammatory and pro-inflammatory cytokines
Timepoint [2] 265665 0
Week 1 :
Pre, 30minutes post each intervention session

Week 2 till discharge :
Pre, 30minutes post each intervention session twice weekly
Secondary outcome [3] 265666 0
Blood Mitochondrial Deoxyribonucleic Acid
(mtDNA)

Peripheral mtDNA levels will assess oxidative stress
Timepoint [3] 265666 0
Baseline and then weekly until discharge from ICU
Secondary outcome [4] 265667 0
Blood Lactate

Blood lactate levels will assess level of lactate as an indicator of oxidative stress
Timepoint [4] 265667 0
Pre, 5 minutes and 30minutes post each intervention session
Secondary outcome [5] 265668 0
Near Infrared Spectroscopy
(NIRS)

NIRS will assess muscle oxygenation
Timepoint [5] 265668 0
Pre and post each intervention session
Secondary outcome [6] 265669 0
Orthogonal Polarisation Spectral Imaging (OPS)

OPS will assess microcirculation
Timepoint [6] 265669 0
Pre and post intervention each intervention session
Secondary outcome [7] 265730 0
Bioelectrical Imepdance Analysis (BIA)

BIA will assess quantity of muscle mass loss or gain
Timepoint [7] 265730 0
Baseline and then weekly until discharge from ICU

Eligibility
Key inclusion criteria
Acutely ill patients who are mechanically ventilated for longer than 48 hours with documented sepsis or those with strong clinical suspicion of possible sepsis
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with head injuries, burns, spinal injuries, multiple fractured lower limbs and acute coronary syndrome

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)
Computerised sequence generated randomisation. Participants will be randomisied either into the intervention arm or control arm of the study.
The randomization sequence will be concealed from consent designee research staff and protected by an electronic password.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be consented by one of three of the chief investigators and randomized to one of two groups (computer generated randomization) at 48 hours of mechanical ventilation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2010
Actual
31/10/2010
Date of last participant enrolment
Anticipated
Actual
31/12/2012
Date of last data collection
Anticipated
Actual
30/06/2013
Sample size
Target
252
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 6858 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 14523 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 257699 0
Charities/Societies/Foundations
Name [1] 257699 0
Physiotherapy Research Foundation
Country [1] 257699 0
Australia
Funding source category [2] 257700 0
Charities/Societies/Foundations
Name [2] 257700 0
The Intensive Care Foundation
Country [2] 257700 0
Australia
Primary sponsor type
Individual
Name
Ms Geetha Kayambu
Address
Burns Trauma and Critical Care Research Centre (BTCCRC)
School of Medicine, The University of Queensland
Level 7, Block 6
Royal Brisbane and Women's Hospital
Bowen Bridge Rd
Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 256914 0
None
Name [1] 256914 0
Address [1] 256914 0
Country [1] 256914 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259731 0
The Human Research Ethics Committee of Royal Brisbane and Women's Hospital
Ethics committee address [1] 259731 0
Ethics committee country [1] 259731 0
Australia
Date submitted for ethics approval [1] 259731 0
19/07/2010
Approval date [1] 259731 0
31/08/2010
Ethics approval number [1] 259731 0
HREC/10/QRBW/279
Ethics committee name [2] 259732 0
Medical Research Ethics Committee of The University of Queensland
Ethics committee address [2] 259732 0
Ethics committee country [2] 259732 0
Australia
Date submitted for ethics approval [2] 259732 0
01/09/2010
Approval date [2] 259732 0
16/09/2010
Ethics approval number [2] 259732 0
2010001178

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31677 0
Address 31677 0
Country 31677 0
Phone 31677 0
Fax 31677 0
Email 31677 0
Contact person for public queries
Name 14924 0
Ms Geetha Kayambu
Address 14924 0
Burns Trauma and Critical Care Research Centre (BTCCRC)
The University of Queensland
School of Medicine
Level 7, Block 6,
Royal Brisbane and Women's Hospital
Herston QLD 4029
Country 14924 0
Australia
Phone 14924 0
+61 7 33465193
Fax 14924 0
+61 7 33655192
Email 14924 0
[email protected]
Contact person for scientific queries
Name 5852 0
Ms Geetha Kayambu
Address 5852 0
Burns Trauma and Critical Care Research Centre (BTCCRC)
The University of Queensland
School of Medicine
Level 7, Block 6,
Royal Brisbane and Women's Hospital
Herston QLD 4029
Country 5852 0
Australia
Phone 5852 0
+61 7 33465193
Fax 5852 0
+61 7 33655192
Email 5852 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEarly rehabilitation in sepsis: A prospective randomised controlled trial investigating functional and physiological outcomes The i-PERFORM Trial (Protocol Article).2011https://dx.doi.org/10.1186/1471-2253-11-21
N.B. These documents automatically identified may not have been verified by the study sponsor.