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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Date results information initially provided
Type of registration
Prospectively registered

Titles & IDs
Public title
Acute Lung Injury - improving functional outcomes in survivors
Scientific title
In Acute Lung Injury survivors, does a program of supervised exercise compared with usual care improve exercise capacity and physical activity?
Secondary ID [1] 259811 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Lung Injury 261392 0
Condition category
Condition code
Respiratory 265547 265547 0 0
Other respiratory disorders / diseases

Study type
Description of intervention(s) / exposure
Subjects assigned to the intervention group will participate in an 8 week exercise program. The program will comprise two supervised sessions each week, conducted by a registered physiotherapist, and an additional minimum of three unsupervised training sessions per week.

Each supervised session will comprise of at least 30 minutes of aerobic exercise in the form of a walking program, and a cycling program on an electromagnetically braked cycle ergometer. The walking program will be prescribed at a walking speed equal to 80% of the average speed achieved during the 6MWT. The cycling program will be prescribed at = 60% of peak power achieved during the CPET. Progression of the intensity and duration of the program’s aerobic components, both supervised and unsupervised, will be titrated to a Borg of 4-6 or a RPE of 14-16 depending on the symptom of exercise limitation.

Each supervised session will also comprise a strengthening program targeting the muscle groups identified as weak in the baseline strength testing. Strength training will be calculated based on 70% of a one-repetition maximum (1RM) as found at baseline. Progression of the strength training will involve increasing the weight by 5% of the 1RM each week.

The unsupervised training sessions will comprise of a walking program that involves a minimum of 30 minutes exercise for each of the sessions.
Intervention code [1] 264241 0
Comparator / control treatment
Usual care for the control group will comprise; (i) usual medications and, (ii) interacting with medical staff as required. For the purposes of this study, the “usual care” group will also interact with the investigators once a week to complete scripted phone interview regarding daily physical activity. This will allow description of changes in daily physical activity in this group associated with ‘spontaneous recovery’ and will assist to control for improvements in the intervention arm resulting purely from attention.
Control group

Primary outcome [1] 262355 0
Peak VO2 will be assessed via a gas analysis system during a cardiopulmonary exercise test (CPET). The CPET allows a detailed analysis of the cardiac and pulmonary responses to a progressive increase in power on a cycle ergometer. Blood lactate concentration during exercise will be measured in a small drop of blood obtained following a puncture of the finger tip using a lancet.
Timepoint [1] 262355 0
The patient will complete a CPET 1 week prior to commencing the intervention or control and 1 week after completing the intervention or control. The first CPET will be conducted within 4-6 weeks of discharge from an acute care facility.
Secondary outcome [1] 273616 0
Knee extension, shoulder flexion, elbow flexion and grip strength will be measured. Isometric knee extensor strength will be measured using a fixed force plate that measures accurately up to1000N (Mecmesin BFG1000). Shoulder flexion and elbow flexion and extension will be measured using a hand held dynamometer. Grip strength will be measured by a JAMAR Adjustable Hand Dynamometer. Multiple measures will be made to account for improvements resulting from familiarisation. The highest within 5% of two other measures will be recorded.
Timepoint [1] 273616 0
1 week prior to commencing the intervention or control and 1 week after completing the intervention or control.
Secondary outcome [2] 273617 0
Exercise capacity will be measured via the 6 minute walk test (6MWT). The 6MWT will be performed twice, separated by a 30 min rest period on a 30 m level course within the hospital. The protocol as established by the American Thoracic Society (ATS) will be adapted to include continuous monitoring of heart rate via a heart rate monitor and arterial oxygen saturation via pulse oximetry.
Timepoint [2] 273617 0
1 week prior to commencing the intervention or control and 1 week after completing the intervention or control.
Secondary outcome [3] 273618 0
Objective assessment of physical activity in daily life will be performed using the SenseWear armband (Body Media, Inc., USA). It is non intrusive and will be worn on the right arm during the waking hours of 7 consecutive days. The SenseWear system has been demonstrated to yield valid and reliable measure of energy expenditure in both healthy and COPD populations.
Timepoint [3] 273618 0
1 week prior to commencing the intervention or control and 1 week after completing the intervention or control.

Key inclusion criteria
Patients will be screened from the point of admission to the ICU, on a daily basis by the unit’s dedicated research nurse, to identify suitability for the study. Inclusion criteria will comprise; (i) age > 18 years and, (ii) meet the American-European Consensus Conference criteria for ALI (iii) intubation and ventilation for > 4 days.
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Exclusion criteria will comprise the presence of any neurological or musculoskeletal condition likely to adversely affect the ability to mobilise safely or to follow commands. This includes; immobility prior to admission, history of recent major pulmonary resection, documented neurological disease including traumatic brain injury, poorly managed psychiatric disorders, diagnosis or treatment for malignant cancer within preceding 12 months, orthopaedic injuries with mobility restrictions, and inability to understand English.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be screened from the point of admission to the ICU, on a daily basis by the unit’s dedicated research nurse, to identify suitability for the study. The ALI survivor group, once able to give active consent, will be approached to participate. Those who consent will be randomised into two groups; intervention and control. Concealment will be maintained using opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed using a computer-generated random number sequence, stratified according to baseline 6MWD (i.e. < or = 300 m vs. > 300 m).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264691 0
Name [1] 264691 0
Intensive Care Foundation
Address [1] 264691 0
Level 2, 10 Levers Terrace
Carlton, Victoria 3053, Australia
Country [1] 264691 0
Funding source category [2] 264692 0
Name [2] 264692 0
University of Newcastle
Address [2] 264692 0
University Drive
Callaghan NSW 2308
Country [2] 264692 0
Primary sponsor type
Jennifer Mackney
School of Health Sciences
University of Newcastle
University Drive
Callaghan NSW 2308
Secondary sponsor category [1] 263825 0
Name [1] 263825 0
Ken Havill
Address [1] 263825 0
Intensive Care Unit
John Hunter Hospital
Lookout Road
New Lambton NSW 2305 Australia
Country [1] 263825 0
Other collaborator category [1] 251879 0
Name [1] 251879 0
Kylie Hill
Address [1] 251879 0
Curtin University
GPO Box U1987
Perth WA 6845 Australia
Country [1] 251879 0

Ethics approval
Ethics application status
Ethics committee name [1] 266684 0
Hunter New England Human Ethics Research Committee
Ethics committee address [1] 266684 0
Research Ethics and Governance
Hunter New England Health
Locked Bag 1
Ethics committee country [1] 266684 0
Date submitted for ethics approval [1] 266684 0
Approval date [1] 266684 0
Ethics approval number [1] 266684 0

Brief summary
Acute Lung Injury (ALI) is caused by damage to the blood vessels in the lung as a result of the body’s response to a significant insult. The initial insult can occur within the lung or outside the lung. Acute Lung Injury is characterised by fluid which leaks into the lungs causing severe hypoxaemia. Patients diagnosed with ALI are critically ill and require an admission to intensive care. Preliminary data suggest that patients who survive ALI go on to experience marked limitations to everyday functioning and impaired quality of life (well being). This research aims to evaluate a program of supervised training on the exercise capacity and physical activity of people who survive ALI.

We hypothesise that compared with usual care, a supervised high intensity exercise training program will be effective at improving exercise capacity and daily physical activity in ALI survivors
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 32357 0
Ms Jennifer Mackney
Address 32357 0
School of Health Sciences, The University of Newcastle, University Drive, Callaghan. NS. 2308
Country 32357 0
Phone 32357 0
+61 2 49217879
Fax 32357 0
Email 32357 0
Contact person for public queries
Name 15604 0
Ms Jenny Mackney
Address 15604 0
School of Health Sciences
University of Newcastle
University Drive
Callaghan NSW 2308
Country 15604 0
Phone 15604 0
+61 2 49217879
Fax 15604 0
Email 15604 0
Contact person for scientific queries
Name 6532 0
Ms Jenny Mackney
Address 6532 0
School of Health Sciences
University of Newcastle
University Drive
Callaghan NSW 2308
Country 6532 0
Phone 6532 0
+61 2 49217879
Fax 6532 0
Email 6532 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
The informed consent provided by participants did not explicity include the sharing and reuse of their data for scientific purposes.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary