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Trial registered on ANZCTR


Registration number
ACTRN12611000034932
Ethics application status
Approved
Date submitted
10/01/2011
Date registered
11/01/2011
Date last updated
18/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Promoting activity for frail aged in post-acute hospital settings: a randomised controlled trial of accelerometry
Scientific title
In frail aged rehabilitation inpatients is provision of activity data from accelerometry monitoring to assist goal setting more effective than usual rehabilitation care in increasing activity levels?
Secondary ID [1] 253374 0
APP: 1007886 National Health and Medical Research Council
Universal Trial Number (UTN)
UTN 1111-1118-9227
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Musculoskeletal De-conditioning 260916 0
Mobility decline 260918 0
Condition category
Condition code
Physical Medicine / Rehabilitation 259075 259075 0 0
Physiotherapy
Musculoskeletal 259076 259076 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will wear an accelerometer from the time of waking in the morning until going to bed in the evening ie during waking hours. The accelerometer will be removed for showering. At commencement, the treating physiotherapist will discuss with the patient their mobility goals, including provisional targets for daily walking time. These goals will be re-examined and modified, informed by the accelerometer data, to motivate the patient to improve activity levels and reach set targets. The targets will be reviewed weekly until discharge or 4 weeks, whichever is sooner. Feedback of the previous day’s walking time will be given to the patient and treating therapist and will be recorded in the patient’s records. Walking times over a week will be summarised in chart form and made available at the weekly case conference. All staff will be trained in the use of accelerometry data and be asked to encourage patients to meet their activity goals.
Intervention code [1] 257816 0
Treatment: Devices
Intervention code [2] 257817 0
Rehabilitation
Comparator / control treatment
Usual rehabilitation care including the setting of mobility goals. Neither staff nor patients will receive data on monitored walking times to aid in the setting of walking time targets.
Control group
Active

Outcomes
Primary outcome [1] 259899 0
Daily walking times as assessed by accelerometry
Timepoint [1] 259899 0
Repeated daily measures during the study period
Secondary outcome [1] 268785 0
Lower extremity function as measured by the Short Physical Performance Battery
Timepoint [1] 268785 0
At study entry and exit
Secondary outcome [2] 268786 0
Functional status as assessed using the interRAI Post-Acute Care instrument
Timepoint [2] 268786 0
At study entry and exit and 28 day phone follow-up post discharge
Secondary outcome [3] 268787 0
Exercise self-efficacy as measured by the Short Self-Efficacy and Outcome Expectation for Exercise Scales
Timepoint [3] 268787 0
At study entry and exit
Secondary outcome [4] 268788 0
Health-related quality of life as measured by EQ-5D
Timepoint [4] 268788 0
At study entry and exit and 28 day phone follow-up post discharge
Secondary outcome [5] 268836 0
Length of stay recorded on hospital discharge records
Timepoint [5] 268836 0
At discharge from rehabilitation

Eligibility
Key inclusion criteria
Patients admitted to post-acute care rehabilitation who are (1) aged greater than or equal to 60 years; (2) able to ambulate independently or with supervision, or who have a rehabilitation goal to become ambulant within the context of the current admission; and (3) expected to have a length of stay of at least 2 weeks will be eligible to participate.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will be those (1) with lower limb amputation; (2) with delirium/agitated dementia; or (3) not expected to walk within 4 weeks of admission.

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)
At each site, within 3 days of admission to post acute care rehabilitation, eligible patients will be identified by a staff member from the rehabilitation team and the names will be given to the research member, who will obtain informed consent for participation. At point of entry into the study, and prior to random allocation to either the intervention or control group, consenting participants will be stratified by mobility status - either walking independently (with or without walking aids) or walking with supervision. A random number sequence will be generated for the order of group allocation within the two strata. Random group allocation will be centrally managed by a member of the research staff who is not involved in assessment of measures or intervention delivery.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random number sequence will be generated using computerised sequence generation for group allocation within the two strata. Random group allocation will be centrally managed by a member of the research staff who is not involved in assessment of measures or intervention delivery.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2011
Actual
31/10/2011
Date of last participant enrolment
Anticipated
Actual
12/09/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
270
Accrual to date
Final
270
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 5064 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 5065 0
Hornsby Ku-ring-gai Hospital - Hornsby
Recruitment hospital [3] 5066 0
Repatriation Hospital - Daw Park
Recruitment postcode(s) [1] 3531 0
4102
Recruitment postcode(s) [2] 3532 0
2077
Recruitment postcode(s) [3] 3533 0
5041

Funding & Sponsors
Funding source category [1] 258290 0
Government body
Name [1] 258290 0
National Health and Medical Research Council
Country [1] 258290 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Research and Innovation Division, The University of Queensland, St Lucia, QLD 4072
Country
Australia
Secondary sponsor category [1] 257454 0
None
Name [1] 257454 0
Address [1] 257454 0
Country [1] 257454 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260276 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 260276 0
Princess Alexandra Hospital, Brisbane, Queensland, 4102, Australia
Ethics committee country [1] 260276 0
Australia
Date submitted for ethics approval [1] 260276 0
18/01/2011
Approval date [1] 260276 0
11/03/2011
Ethics approval number [1] 260276 0
HREC/11/QPAH/043
Ethics committee name [2] 294187 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [2] 294187 0
Level 2 Building 31, Royal North Shore Hospital, St Leonards, NSW 2065
Ethics committee country [2] 294187 0
Australia
Date submitted for ethics approval [2] 294187 0
03/02/2011
Approval date [2] 294187 0
03/03/2011
Ethics approval number [2] 294187 0
HREC/11/HAWKE/14
Ethics committee name [3] 294188 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [3] 294188 0
Flinders Medical Centre, Bedford Park, SA 5042, Australia
Ethics committee country [3] 294188 0
Australia
Date submitted for ethics approval [3] 294188 0
14/01/2011
Approval date [3] 294188 0
23/03/2011
Ethics approval number [3] 294188 0
SAC HREC 012.11

Summary
Brief summary
BACKGROUND
A goal in rehabilitation for older people is promotion of mobility to reverse functional decline and deconditioning. Recent developments in accelerometry for quantifying ambulatory activity can assist clinical practice in rehabilitation settings.

AIM
The study tests the hypothesis that use of accelerometry to provide accurate activity data to patients and clinicians, in the context of explicit goal setting, substantially increases patient walking activity. The study will also explore the effects of increased activity on patient outcomes and undertake a cost utility analysis.

RESEARCH PLAN
A randomised controlled trial will be conducted in Geriatric Rehabilitation Units at 3 sites (QLD, NSW, SA). Eligible patients are aged greater than or equal to 60 and able to ambulate. Based on pilot data, a sample size of 270 patients (135 per group) is required to demonstrate a mean significant differencein daily walking time of 33% between intervention and control groups.Accelerometers will be fitted to eligible subjects to monitor daily activity. Intervention subjects will be offered a formal activity-related rehabilitation goal, and receive daily feedback, sourced from the accelerometer, of their activity levels. Neither staff nor subjects in the control arm of the trial will receive data on walking times. The primary outcome measure will be walking times measured by accelerometry. Secondary outcome measures will include lower extremity function, quality of life, length of stay, post discharge hospital readmissions and level of care at one month follow-up. The time frame for the study is two years six months.

SIGNIFICANCE
If patient activity can be increased through the use of accelerometer data, it will revolutionise the management of activity in hospital. There will be enormous impetus to further develop accelerometer technology for clinical application so that activity prescription will be a routine component of a rehabilitation care plan.
Trial website
Trial related presentations / publications
Dakin LE, Gray LC, Peel NM, Salih SA, Cheung VH. Promoting walking amongst older patients in rehabilitation: are accelerometers the answer? J Nutr Health Aging 2010;14(10):863-5.
Public notes

Contacts
Principal investigator
Name 32069 0
Prof Leonard Gray
Address 32069 0
Centre for Research in Geriatric Medicine
The University of Queensland School of Medicine
Level 2 Building 33
Princess Alexandra Hospital
Woolloongabba QLD 4102
Country 32069 0
Australia
Phone 32069 0
+61 7 3176 5530
Fax 32069 0
Email 32069 0
[email protected]
Contact person for public queries
Name 15316 0
Dr Nancye Peel
Address 15316 0
Centre for Research in Geriatric Medicine, The University of Queensland School of Medicine, Level 2, Building 33, Princess Alexandra Hospital, Woolloongabba, QLD 4102
Country 15316 0
Australia
Phone 15316 0
+61 7 3176 7402
Fax 15316 0
+61 7 3176 6945
Email 15316 0
[email protected]
Contact person for scientific queries
Name 6244 0
Professor Len Gray
Address 6244 0
Centre for Research in Geriatric Medicine, The University of Queensland School of Medicine, Level 2, Building 33, Princess Alexandra Hospital, Woolloongabba, QLD 4102
Country 6244 0
Australia
Phone 6244 0
+61 7 3176 5530
Fax 6244 0
+61 7 3176 6945
Email 6244 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
EmbasePromoting activity in geriatric rehabilitation: A randomized controlled trial of accelerometry.2016https://dx.doi.org/10.1371/journal.pone.0160906
N.B. These documents automatically identified may not have been verified by the study sponsor.