Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000166673
Ethics application status
Approved
Date submitted
12/07/2005
Date registered
16/08/2005
Date last updated
5/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Testing a home based rehabilitation program for survivors of a critical illness: a randomised controlled trial
Scientific title
Testing a home based rehabilitation program for survivors of a critical illness: a randomised controlled trial
Secondary ID [1] 262148 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-critical illness 261 0
Condition category
Condition code
Physical Medicine / Rehabilitation 293 293 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
8-week physical exercise program (home visits at weeks 1, 3 and 6 post-discharge, with phonecall follow-up in the remaining weeks) to monitor progress and tailor training.
Intervention code [1] 15 0
Rehabilitation
Comparator / control treatment
The control group receives blinded 'assessment-only' visits.
Control group
Active

Outcomes
Primary outcome [1] 346 0
Physical function (measured by PF scale of SF-36)
Timepoint [1] 346 0
8 weeks and 26 weeks
Secondary outcome [1] 782 0
6-minute walk test
Timepoint [1] 782 0
8 weeks and 26 weeks
Secondary outcome [2] 783 0
Other SF-36 domains
Timepoint [2] 783 0
8 weeks and 26 weeks
Secondary outcome [3] 784 0
Post-traumatic stress symptoms (Impact of Events Scale - IES)
Timepoint [3] 784 0
8 weeks and 26 weeks
Secondary outcome [4] 785 0
Psychological distress (Depression Anxiety and Stress Scale - DASS)
Timepoint [4] 785 0
8 weeks and 26 weeks

Eligibility
Key inclusion criteria
ICU length of stay > 48 hours; discharged home to self-care; geographical proximity to study hospitals.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Organised rehabilitation as part of usual care; neurological, spinal or skeletal dysfunction precludes physical rehabilitation intervention; receiving palliative care.

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)
central telephone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
block
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2005
Actual
1/06/2005
Date of last participant enrolment
Anticipated
Actual
29/08/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
195
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA

Funding & Sponsors
Funding source category [1] 352 0
Government body
Name [1] 352 0
NHMRC Project grant
Country [1] 352 0
Australia
Primary sponsor type
University
Name
University of Technology
Address
Sydney
Country
Australia
Secondary sponsor category [1] 277 0
University
Name [1] 277 0
Griffith University
Address [1] 277 0
Queensland
Country [1] 277 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1320 0
University of Technology Sydney
Ethics committee address [1] 1320 0
Ethics committee country [1] 1320 0
Australia
Date submitted for ethics approval [1] 1320 0
Approval date [1] 1320 0
01/06/2005
Ethics approval number [1] 1320 0
Ethics committee name [2] 1321 0
South East Sydney Area Health Service (Eastern Section)
Ethics committee address [2] 1321 0
Ethics committee country [2] 1321 0
Australia
Date submitted for ethics approval [2] 1321 0
Approval date [2] 1321 0
Ethics approval number [2] 1321 0
Ethics committee name [3] 1322 0
South East Sydney Area Health Service (Southern Section)
Ethics committee address [3] 1322 0
Ethics committee country [3] 1322 0
Australia
Date submitted for ethics approval [3] 1322 0
Approval date [3] 1322 0
Ethics approval number [3] 1322 0
Ethics committee name [4] 1323 0
Northern Sydney and Central Coast Area Health Service
Ethics committee address [4] 1323 0
Ethics committee country [4] 1323 0
Australia
Date submitted for ethics approval [4] 1323 0
Approval date [4] 1323 0
Ethics approval number [4] 1323 0
Ethics committee name [5] 1324 0
Royal Brisbane and Womens' Hospital
Ethics committee address [5] 1324 0
Ethics committee country [5] 1324 0
Australia
Date submitted for ethics approval [5] 1324 0
Approval date [5] 1324 0
Ethics approval number [5] 1324 0

Summary
Brief summary
People who survive a critical illness often take a significant time to recover, and may not return to pre-illness levels of activity and function. This study will test whether an 8-week home based physical exercise program will provide any benefits to participants receiving the program, compared to participants not receiving the treatment. All participants will be assessed at weeks 1, 8 and 26 post-hospital discharge. Participants randomised to receive the exercise program will be visited at home by a trainer on 3 occasions in the 8-week period.
Trial website
Trial related presentations / publications
Elliott D, McKinley S, Alison JA, Aitken LM, King MT. 2006 Study protocol: home-based physical rehabilitation for survivors of a critical illness. Critical Care 10:R90 (7 pages); http://ccforum.com/10/3/R90

Elliott D, McKinley, SM, Alison, JA, Aitken, LM, King, MT, Leslie, G, Kenny, P, Taylor, PA, Foley, R, Burmeister E. 2011 Health-related quality of life and physical recovery after a critical illness: a multi-centre randomised controlled trial of a home-based physical rehabilitation program, Critical Care, 15:R142.

McKinley S, Elliott D, Alison, JA, Aitken LM, King M, Leslie GD, Kenny P. 2012 Sleep and other factors associated with mental health and psychological distress after intensive care for critical illness. Intensive Care Medicine, 38: 627-33

Alison, JA, Kenny P, King MT, McKinley S, Aitken LM, Leslie GD, Elliott D. 2012 Repeatability of six-minute walk test and relation to physical function in survivors of a critical illness. 2012 Physical Therapy, 92:1556-63

Aitken LM, Burmeister E, McKinley S, Alison JA, King MT, Leslie GD, Elliott D. 2015. Physical recovery in intensive care unit survivors: a cohort analysis. American Journal of Critical Care, 24: 33-40

Chan K, Pfoh E, Denehy L, Elliott D, Holland A, Dinglas V, Needham D. 2015 Construct validity and minimal important difference of 6-minute walk distance in survivors of acute respiratory failure. Chest 147(5): 1316-26
Public notes

Contacts
Principal investigator
Name 35566 0
Prof Doug Elliott
Address 35566 0
Faculty of Health, University of Technology Sydney, Broadway 2007
Country 35566 0
Australia
Phone 35566 0
61 2 9514 4832
Fax 35566 0
Email 35566 0
Doug.Elliott@uts.edu.au
Contact person for public queries
Name 9204 0
Prof Professor Doug Elliott
Address 9204 0
Faculty of Health, University of Technology Sydney, Broadway 2007
Country 9204 0
Australia
Phone 9204 0
61 2 9514 4832
Fax 9204 0
61 2 9514 4835
Email 9204 0
Doug.Elliott@uts.edu.au
Contact person for scientific queries
Name 132 0
Prof Professor Doug Elliott
Address 132 0
Faculty of Nursing, Midwifery and Health,
University of Technology, Sydney
Broadway NSW 2007
Country 132 0
Australia
Phone 132 0
61 2 9514 4832
Fax 132 0
61 2 9514 4835
Email 132 0
Doug.Elliott@uts.edu.au

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
EmbasePhysical recovery in intensive care unit survivors: a cohort analysis.2015https://dx.doi.org/10.4037/ajcc2015870
Dimensions AIRepeatability of the Six-Minute Walk Test and Relation to Physical Function in Survivors of a Critical Illness2012https://doi.org/10.2522/ptj.20110410
N.B. These documents automatically identified may not have been verified by the study sponsor.