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Trial registered on ANZCTR
Registration number
ACTRN12613000884707
Ethics application status
Approved
Date submitted
16/07/2013
Date registered
8/08/2013
Date last updated
20/01/2020
Date data sharing statement initially provided
17/12/2018
Date results information initially provided
17/12/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Optimising rehabilitation outcomes in frail older adults: effects of increasing the amount of physical activity
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Scientific title
Does increasing the amount of physical activity in frail older adults during hospital-based rehabilitation improve mobility outcomes when compared to usual care.
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Secondary ID [1]
282667
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Nil
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Universal Trial Number (UTN)
U1111-1144-5714
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Trial acronym
THE MOVE TRIAL
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Frailty
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Condition category
Condition code
Physical Medicine / Rehabilitation
289702
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0
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Physiotherapy
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
In addition to usual care provided by a multidisciplinary rehabilitation team, the intervention group will receive a protocol-specified intervention focused on increasing the amount of time spent standing and walking. This will be delivered as extra sessions on weekdays (1-2 sessions per day, approximate total 30 mins) and weekend days (1-2 sessions, approximate total 45 mins) for the duration of their rehabilitation stay. The intervention will be provided by a trial physiotherapist and or allied health assistant and tailored for each participant. Intervention adherence will be monitored using staff recordings of the amount of time participants spend performing various activities during each session. Lightweight wristwatch-sized accelerometers will be used to monitor activity of each participant over a 5 day period during their rehabilitation admission.
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Intervention code [1]
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Rehabilitation
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Comparator / control treatment
The control group will receive usual care, provided by a multidisciplinary team (including physiotherapy, occupational therapy, medical, nursing and other allied health input as indicated). In addition, to control for the extra physical activity that the experimental group receives, participants in the control group shall have additional social and recreational activities according to their interests, as well as upper limb exercises that have minimal impact on mobility. These will be undertaken with the participant either sitting in a chair or resting in bed. Overall extra contact time will be matched for intervention and control groups.
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Control group
Active
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Outcomes
Primary outcome [1]
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Mobility - Gait Speed measured with the 6 metre walk test.
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Assessment method [1]
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Timepoint [1]
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Discharge from inpatient rehabilitation.
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Secondary outcome [1]
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Mobility - Functional Gait Speed measured with the Timed Up and Go Test (TUG).
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Assessment method [1]
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Timepoint [1]
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Admission, Discharge and at 6 months post discharge.
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Secondary outcome [2]
303259
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Mobility - Functional Mobility measured with the De Morton Mobility Index (DEMMI).
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Assessment method [2]
303259
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Timepoint [2]
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Admission, Discharge and at 6 months post discharge.
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Secondary outcome [3]
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Functional Level - measured using the Mobility and Locomotion subsections of the FIM (Functional Independence Measure).
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Assessment method [3]
303260
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Timepoint [3]
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Admission, Discharge and at 6 months post discharge.
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Secondary outcome [4]
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Quality of life - measured using the EuroQol Health Questionnaire (EQ5D) and the EQ-Visual Analogue Scale
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Assessment method [4]
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Timepoint [4]
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Admission, Discharge and at 6 months post discharge.
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Secondary outcome [5]
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Falls - measured using a monthly calendar during the 6 month period from discharge to follow up.
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Assessment method [5]
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Timepoint [5]
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Discharge - 6 months post discharge
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Secondary outcome [6]
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Mobility - Gait Speed measured with the 6 metre walk test.
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Assessment method [6]
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Timepoint [6]
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6 months post discharge
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Secondary outcome [7]
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All adverse events during the intervention and 6 month follow-up periods. These include falls, unplanned re-admission to an acute service during rehabilitation or within 6 months post discharge and mortality. Falls will be defined using the WHO 2011 definition. Falls during the intervention period (i.e. during hospitalisation) will be obtained from hospital records of falls. Falls post discharge will be obtained via falls calendars.
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Assessment method [7]
303355
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Timepoint [7]
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Admission - 6 months post discharge.
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Secondary outcome [8]
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Cost effectiveness and cost utility
The main output of interest is incremental cost-effectiveness ratios in terms of net costs per unit of health gain. Net costs will comprise the costs of enhanced physical activity program minus costs saved from the reduction in downstream health services utilization. Health gains can be measured in a variety of ways. For the current study, in addition to clinical outcomes, we shall estimate years of life gained and quality-adjusted life years (QALYs) gained. Both shall be enabled by the collection of time-to-outcome data and the latter also by collection of the EuroQoL Quality of Life data.
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Assessment method [8]
303357
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Timepoint [8]
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6 month post discharge
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Eligibility
Key inclusion criteria
(i) over 60 years of age
(ii) a goal of admission is to ‘improve weight-bearing mobility or improve walking’ as determined by either the admission referral or the treating therapist.
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Minimum age
60
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
(i) specific medical restrictions that limit mobilisation (e.g. non weight bearing)
(ii) already enrolled in a different RCT
(iii) primary reason for admission is to await a residential care placement
(iv) previously enrolled in the current trial
(v) primary reason for admission is for carer training
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited from rehabilitation and Geriatric Evaluation and Management wards. Consent will be obtained from the participant or next of kin if the participant is unable to give consent due to cognitive impairment, within 48 hours of admission to the ward.
Participants will be individually randomised to an intervention group (enhanced physical activity) or a control group (usual care) according to a computer generated randomisation procedure performed by a third party. Randomisiation will occur after baseline assessment.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be stratified by functional level (ambulant/ non ambulant) and site. A randomisation table will be created by computer software
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Baseline data will be examined to ensure that the control group and the intervention group are comparable using descriptive statistics. Between group differences in terms of the primary outcome variable (gait speed) will be assessed using a 0.05 level of significance.
Pilot data has shown the median gait speed of people discharged from rehabilitation is .46 m/s, sd = .18m/sec. Sample size estimation was based on the intervention group acheiving an increase of .1m/sec, which has been previously reported to be the minimally clinically important difference for gait speed in older adults. Assuming two groups of equal size and using the conventional settings of two tailed significance threshold alpha of .05 and power to yield a statistically significant result of 90%, a sample size of 69 people in each group is required. Allowing for 14% of participants to be unable to complete the walk test on discharge, and a 25% dropout, an estimated total of 198 participants are required.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
19/08/2013
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Actual
29/01/2014
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Date of last participant enrolment
Anticipated
30/01/2015
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Actual
15/04/2015
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Date of last data collection
Anticipated
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Actual
12/11/2015
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Sample size
Target
198
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Accrual to date
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Final
198
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
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Recruitment hospital [2]
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Kingston Centre - Cheltenham
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Recruitment postcode(s) [1]
6960
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3081 - Heidelberg Rgh
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Recruitment postcode(s) [2]
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3192 - Cheltenham
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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National Health and Medical Research Council
Project Grant - ID1042680
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Address [1]
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GPO Box 1421
Canberra ACT 2601
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Country [1]
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Australia
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Primary sponsor type
University
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Name
La Trobe University
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Address
La Trobe University
Melbourne Victoria 3086
Australia
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Country
Australia
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Secondary sponsor category [1]
286190
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None
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Name [1]
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Address [1]
286190
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Country [1]
286190
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Other collaborator category [1]
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Hospital
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Name [1]
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Heidelberg Repatriation Hospital
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Address [1]
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Heidelberg Repatriation Hospital, Austin Health, PO Box 5444, Heidelberg West, VIC 3081
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Country [1]
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Australia
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Other collaborator category [2]
277451
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Hospital
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Name [2]
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The Kingston Centre
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Address [2]
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The Kingston Centre, Southern Health, Warrigal Road, Cheltenham, VIC 3192
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Country [2]
277451
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289423
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La Trobe University Human Ethics Committee
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Ethics committee address [1]
289423
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Secretary, La Trobe University Human Ethics Committee Research and Graduate Studies Office Level 2,
David Myers Building
La Trobe University
BUNDOORA VIC 3086
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Ethics committee country [1]
289423
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Australia
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Date submitted for ethics approval [1]
289423
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Approval date [1]
289423
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04/02/2013
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Ethics approval number [1]
289423
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12-122
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Ethics committee name [2]
289424
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Austin Health Human Research Ethics Committee
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Ethics committee address [2]
289424
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Research Ethics
Office for Research
Level 6 HSB Austin Health
PO Box 5555
Heidelberg
Victoria
Australia, 3084
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Ethics committee country [2]
289424
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Australia
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Date submitted for ethics approval [2]
289424
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18/04/2013
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Approval date [2]
289424
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04/07/2013
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Ethics approval number [2]
289424
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H2013/05042
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Ethics committee name [3]
289455
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Monash Health Human Research Ethics Committee B
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Ethics committee address [3]
289455
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Research Directorate
Level 4, Main Block,
Monash Medical Centre
246 Clayton Road
CLAYTON VIC 3168
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Ethics committee country [3]
289455
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Australia
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Date submitted for ethics approval [3]
289455
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Approval date [3]
289455
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02/07/2014
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Ethics approval number [3]
289455
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Ethics committee name [4]
289456
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University of Melbourne Behavioural & Social Sciences Human Ethics SubCommittee
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Ethics committee address [4]
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Melbourne Research Office
The University of Melbourne
MELBOURNE VIC 3010
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Ethics committee country [4]
289456
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Australia
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Date submitted for ethics approval [4]
289456
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Approval date [4]
289456
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10/10/2013
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Ethics approval number [4]
289456
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Ethics committee name [5]
289457
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Curtin University of Technology Human Research Ethics Committee
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Ethics committee address [5]
289457
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Office of Research and Development
Curtin University
GPO Box U 1987
Perth, Western Australia 6845
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Ethics committee country [5]
289457
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Australia
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Date submitted for ethics approval [5]
289457
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Approval date [5]
289457
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04/03/2014
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Ethics approval number [5]
289457
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Summary
Brief summary
The main aim of this study is to investigate whether increasing the amount of physical activity results in better
mobility outcomes in frail, older people. This study will be performed during hospital based rehabilitation and will be
compared to mobility outcomes resulting from usual care. A second aim is to investigate whether this physical activity intervention results in improvements in quality of life. Finally we plan to investigate whether increasing the
amount of physical activity during rehabilitation is cost effective.
Participants will be recruited from two Victorian hospitals which offer inpatient rehabilitation to older adults. Older
people receiving inpatient rehabilitation will be randomly assigned to an intervention group or a control group. The
intervention group will receive extra physical activity on weekdays and weekends while the control group will receive
additional social interaction. Both groups will be assessed at baseline, discharge from hospital and at 6 months.
The primary outcome for this study is gait speed, as measured by the 6 metre walk test. Other outcomes relating to mobility, function and quality of life will also be assessed. At the end of the study a health economic analysis will be performed to assess whether the extra physical activity provided was cost effective, all factors considered.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Meg Morris
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Address
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School of Allied Health
Faculty of Health Sciences
La Trobe University
Bundoora
Victoria, 3086.
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Country
40734
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Australia
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Phone
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+61 3 94796080
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Fax
40734
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+61 3 9479 5768
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Email
40734
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[email protected]
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Contact person for public queries
Name
40735
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Dr Joanne Wittwer
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Address
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Physiotherapy Department
Faculty of Health Sciences
La Trobe University
Bundoora
Victoria, 3086.
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Country
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Australia
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Phone
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+61 3 94795808
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Fax
40735
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Email
40735
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[email protected]
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Contact person for scientific queries
Name
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Dr Cathy Said
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Address
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Austin Health,
PO Box 5444,
Heidelberg West,
VIC 3081
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Country
40736
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Australia
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Phone
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+61 3 9496 2055
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Fax
40736
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Email
40736
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Permission for this was not sought in original ethics application
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
175
Study protocol
Said CM, Morris ME, McGinley JL, Szoeke C, Workman...
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176
Statistical analysis plan
See supplementary data Said CM, Morris ME, McGinl...
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Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
Said CM, Morris ME, McGinley JL, Szoeke C, Workman...
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Plain language summary
No
99 participants were randomly allocated to the int...
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Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Evaluating the effects of increasing physical activity to optimize rehabilitation outcomes in hospitalized older adults (MOVE Trial): Study protocol for a randomized controlled trial.
2015
https://dx.doi.org/10.1186/s13063-014-0531-y
N.B. These documents automatically identified may not have been verified by the study sponsor.
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