Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000298910
Ethics application status
Approved
Date submitted
17/03/2011
Date registered
21/03/2011
Date last updated
2/07/2019
Date data sharing statement initially provided
2/07/2019
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
Nil
Universal Trial Number (UTN)
U1111-1120-0915
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

Intervention/exposure
Study type
Interventional
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
Rehabilitation
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
Active

Outcomes
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.

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Treatment
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/04/2011
Actual
23/09/2011
Date of last participant enrolment
Anticipated
Actual
25/06/2014
Date of last data collection
Anticipated
Actual
1/10/2014
Sample size
Target
26
Accrual to date
Final
7
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 264691 0
Charities/Societies/Foundations
Name [1] 264691 0
Intensive Care Foundation
Country [1] 264691 0
Australia
Funding source category [2] 264692 0
University
Name [2] 264692 0
University of Newcastle
Country [2] 264692 0
Australia
Primary sponsor type
Individual
Name
Jennifer Mackney
Address
School of Health Sciences
University of Newcastle
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 263825 0
Individual
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
Australia
Other collaborator category [1] 251879 0
Individual
Name [1] 251879 0
Kylie Hill
Address [1] 251879 0
Curtin University
GPO Box U1987
Perth WA 6845 Australia
Country [1] 251879 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266684 0
Hunter New England Human Ethics Research Committee
Ethics committee address [1] 266684 0
Ethics committee country [1] 266684 0
Australia
Date submitted for ethics approval [1] 266684 0
Approval date [1] 266684 0
27/01/2011
Ethics approval number [1] 266684 0
HREC/10/HNE/333

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

Contacts
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
Australia
Phone 32357 0
+61 2 49217879
Fax 32357 0
Email 32357 0
[email protected]
Contact person for public queries
Name 15604 0
Jenny Mackney
Address 15604 0
School of Health Sciences
University of Newcastle
University Drive
Callaghan NSW 2308
Country 15604 0
Australia
Phone 15604 0
+61 2 49217879
Fax 15604 0
Email 15604 0
[email protected]
Contact person for scientific queries
Name 6532 0
Jenny Mackney
Address 6532 0
School of Health Sciences
University of Newcastle
University Drive
Callaghan NSW 2308
Country 6532 0
Australia
Phone 6532 0
+61 2 49217879
Fax 6532 0
Email 6532 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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 Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.