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Trial registered on ANZCTR


Registration number
ACTRN12605000776606
Ethics application status
Approved
Date submitted
1/12/2005
Date registered
5/12/2005
Date last updated
21/11/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The EXERCISE trial
Scientific title
Evaluation of exercise rehabilitation for survivors of intensive care
Universal Trial Number (UTN)
Trial acronym
The ICU Exercise Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ICU survivors 932 0
Condition category
Condition code
Physical Medicine / Rehabilitation 1001 1001 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention cohort will receive an intensive rehabilitation protocol commencing during their ICU stay. The intervention protocol will consist of an exercise regimen based on performance of the baseline ‘MUSCLE’ test. Exercises will include sitting out of bed, sit to stand exercise with or without assistance, marching on the spot and active shoulder elevation. These exercises are based on pilot data obtained from an Australia wide questionnaire (Skinner et al 2008) obtained prior to study commencement. For participants unable to sit out of bed, active and active assisted upper and lower limb exercises will be performed. The use of a tilt table or standing frame may be employed. Treatment in the ICU will involve exercise for up to a total of fifteen minutes per day for each participant. Exercise will increase to twice daily once they are able to be disconnected from the ventilator for > 4 hours. Once discharged to the general ward the physiotherapist will continue and progress an intensive rehabilitation program. Exercise will be progressed according to performance on the 6 MWT, calculating 6 minute walk work or if able, a submaximal V02 test . The physiotherapist will treat each participant twice daily aiming to exercise for 30min at each session with gradual progression toward one 60min exercise session until discharge from hospital. Upon discharge home participants will be booked to commence their outpatient program (one 60 minute session offered three times a week). Exercise at home in the form of a walking program will be encouraged on days not attending the program. Ward and out patient exercise classes will comprise functional, resistance and aerobic components with intensity set using the modified Borg scale. Primary outcome measures will be undertaken at baseline, 8-10 weeks post hospital discharge and 6 and 12 months post ICU discharge. The intervention group will also be assessed pre and post outpatient program.
Intervention code [1] 781 0
Rehabilitation
Comparator / control treatment
Both groups will receive usual medical, physiotherapy and nursing care in the ICU, ward and upon hospital discharge. Any participants may be transferred to a rehabilitation facility if deemed necessary as per standard care. The ward physiotherapist is involved in discharge planning for all participants. Primary outcome measures will be undertaken at baseline, 8-10 weeks post hospital discharge and 6 and 12 months post ICU discharge.
Control group
Active

Outcomes
Primary outcome [1] 1334 0
6 Minute Walk Test
Timepoint [1] 1334 0
ICU discharge, discharge home, 8-10 weeks post hospital discharge, 6 and 12 months post ICU discharge.
Primary outcome [2] 1335 0
Quality of Life (SF-36v2) to measure the health status of participants.
Timepoint [2] 1335 0
Baseline, 8-10 weeks post hospital discharge, 6 and 12 months post ICU discharge.
Primary outcome [3] 1336 0
AQoL
Timepoint [3] 1336 0
Baseline, 8-10 weeks post hospital discharge, 6 and 12 months post ICU discharge.
Primary outcome [4] 3679 0
Economic evaluation to allow a cost-effectiveness and cost utility analysis of the intervention.
Timepoint [4] 3679 0
8-10 weeks post hospital discharge, 6 and 12 months post ICU discharge.
Primary outcome [5] 3680 0
'MUSCLE' test - test found to be reliable and responsive to change in pilot study (Skinner et al in press).
Timepoint [5] 3680 0
Baseline and ICU discharge
Primary outcome [6] 3681 0
Timed up and go test (TUG)
Timepoint [6] 3681 0
ICU discharge, discharge home, 8-10 weeks post hospital discharge, 6 and 12 months post ICU discharge.
Primary outcome [7] 3682 0
free living activity levels (accelerometer and Physical Activity Scale for the Elderley)
Timepoint [7] 3682 0
4-5 weeks post discharge home
Secondary outcome [1] 2377 0
Hours of mechanical ventilation
Timepoint [1] 2377 0
reported at the completion of the trial
Secondary outcome [2] 2378 0
ICU hours
Timepoint [2] 2378 0
reported at the completion of the trial
Secondary outcome [3] 2379 0
ICU readmission
Timepoint [3] 2379 0
reported at the completion of the trial
Secondary outcome [4] 6213 0
correlation between proxy and patient completion of HRQoL questionnaires
Timepoint [4] 6213 0
8-10 weeks post hospital discharge, 6 and 12 months post ICU discharge.

Eligibility
Key inclusion criteria
ICU LOS of 5 or more days, able to understand written and spoken English, reside in greater Melbourne defined as within a radius of 50km from Austin Health in Heidelberg.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Neurological permanent weakness/conditions where exercise is contraindicated. Assessed by medical staff as approaching imminent death or withdrawal of medical management is being considered within 48 hours. Patients who have an ICU length of stay greater than 5 days due solely to ward bed blockages. Patients who would have been unable to perform the study physical outcome measures pre-morbidly due to a condition impairing their mobility.

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 envelopes with sequence concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A statistician from the Department of Mathematics and Statistics at The University of Melbourne will perform the randomisation by creation of a random numbers table and use of colour coded (for stratification) opaque, numbered 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] 1099 0
Government body
Name [1] 1099 0
NHMRC
Address [1] 1099 0
MDP33, GPO Box 1421, Canberra ACT 2601
Country [1] 1099 0
Australia
Funding source category [2] 2825 0
Government body
Name [2] 2825 0
Physiotherapy Research Foundation
Address [2] 2825 0
6/651 Victoria Street, Abbortsford
Country [2] 2825 0
Australia
Primary sponsor type
Individual
Name
Dr Linda Denehy
Address
School of Physiotherapy, University of Melbourne, Level 1, 200 Berkeley St Carlton 3010
Country
Australia
Secondary sponsor category [1] 964 0
Individual
Name [1] 964 0
Dr. Stephen Warrillow
Address [1] 964 0
C/O Intensive Care Unit, Level 2 Austin Tower
Austin Health, Burgundy Street, Heidelberg 3081
Country [1] 964 0
Australia
Secondary sponsor category [2] 965 0
Individual
Name [2] 965 0
Ms Elizabeth Skinner
Address [2] 965 0
Physiotherapy Department Austin Health Burgundy Street Heidelberg VIC 3081
Country [2] 965 0
Australia
Secondary sponsor category [3] 966 0
Individual
Name [3] 966 0
Ms. Susan Berney
Address [3] 966 0
Physiotherapy Department Austin Health Burgundy Street Heidelberg VIC 3081
Country [3] 966 0
Australia

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35357 0
Address 35357 0
Country 35357 0
Phone 35357 0
Fax 35357 0
Email 35357 0
Contact person for public queries
Name 9970 0
Sue Berney
Address 9970 0
Physiotherapy Department
Austin Health
Burgundy Street
Heidelberg VIC 3081
Country 9970 0
Australia
Phone 9970 0
+61 3 94965000
Fax 9970 0
+61 9 94576326
Email 9970 0
sue.berney@austin.org.au
Contact person for scientific queries
Name 898 0
Dr Linda Denehy
Address 898 0
School of Physiotherapy, University of Melbourne, Level 1, 200 Berkeley St Carlton 3010
Country 898 0
Australia
Phone 898 0
+61 3 83444171
Fax 898 0
+61 3 83444188
Email 898 0
l.denehy@unimelb.edu.au

No information has been provided regarding IPD availability
Summary results
No Results