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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 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
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.
Secondary ID [1] 282667 0
Nil
Universal Trial Number (UTN)
U1111-1144-5714
Trial acronym
THE MOVE TRIAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frailty 289365 0
Condition category
Condition code
Physical Medicine / Rehabilitation 289702 289702 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 287331 0
Rehabilitation
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.
Control group
Active

Outcomes
Primary outcome [1] 289798 0
Mobility - Gait Speed measured with the 6 metre walk test.
Timepoint [1] 289798 0
Discharge from inpatient rehabilitation.
Secondary outcome [1] 303258 0
Mobility - Functional Gait Speed measured with the Timed Up and Go Test (TUG).
Timepoint [1] 303258 0
Admission, Discharge and at 6 months post discharge.
Secondary outcome [2] 303259 0
Mobility - Functional Mobility measured with the De Morton Mobility Index (DEMMI).
Timepoint [2] 303259 0
Admission, Discharge and at 6 months post discharge.
Secondary outcome [3] 303260 0
Functional Level - measured using the Mobility and Locomotion subsections of the FIM (Functional Independence Measure).
Timepoint [3] 303260 0
Admission, Discharge and at 6 months post discharge.
Secondary outcome [4] 303261 0
Quality of life - measured using the EuroQol Health Questionnaire (EQ5D) and the EQ-Visual Analogue Scale
Timepoint [4] 303261 0
Admission, Discharge and at 6 months post discharge.
Secondary outcome [5] 303262 0
Falls - measured using a monthly calendar during the 6 month period from discharge to follow up.
Timepoint [5] 303262 0
Discharge - 6 months post discharge
Secondary outcome [6] 303350 0
Mobility - Gait Speed measured with the 6 metre walk test.
Timepoint [6] 303350 0
6 months post discharge
Secondary outcome [7] 303355 0
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.
Timepoint [7] 303355 0
Admission - 6 months post discharge.
Secondary outcome [8] 303357 0
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.
Timepoint [8] 303357 0
6 month post discharge

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.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

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)
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.
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
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/08/2013
Actual
29/01/2014
Date of last participant enrolment
Anticipated
30/01/2015
Actual
15/04/2015
Date of last data collection
Anticipated
Actual
12/11/2015
Sample size
Target
198
Accrual to date
Final
198
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1123 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment hospital [2] 1124 0
Kingston Centre - Cheltenham
Recruitment postcode(s) [1] 6960 0
3081 - Heidelberg Rgh
Recruitment postcode(s) [2] 6961 0
3192 - Cheltenham

Funding & Sponsors
Funding source category [1] 287448 0
Government body
Name [1] 287448 0
National Health and Medical Research Council
Project Grant - ID1042680
Country [1] 287448 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University
Melbourne Victoria 3086
Australia
Country
Australia
Secondary sponsor category [1] 286190 0
None
Name [1] 286190 0
Address [1] 286190 0
Country [1] 286190 0
Other collaborator category [1] 277450 0
Hospital
Name [1] 277450 0
Heidelberg Repatriation Hospital
Address [1] 277450 0
Heidelberg Repatriation Hospital, Austin Health, PO Box 5444, Heidelberg West, VIC 3081
Country [1] 277450 0
Australia
Other collaborator category [2] 277451 0
Hospital
Name [2] 277451 0
The Kingston Centre
Address [2] 277451 0
The Kingston Centre, Southern Health, Warrigal Road, Cheltenham, VIC 3192
Country [2] 277451 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289423 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 289423 0
Ethics committee country [1] 289423 0
Australia
Date submitted for ethics approval [1] 289423 0
Approval date [1] 289423 0
04/02/2013
Ethics approval number [1] 289423 0
12-122
Ethics committee name [2] 289424 0
Austin Health Human Research Ethics Committee
Ethics committee address [2] 289424 0
Ethics committee country [2] 289424 0
Australia
Date submitted for ethics approval [2] 289424 0
18/04/2013
Approval date [2] 289424 0
04/07/2013
Ethics approval number [2] 289424 0
H2013/05042
Ethics committee name [3] 289455 0
Monash Health Human Research Ethics Committee B
Ethics committee address [3] 289455 0
Ethics committee country [3] 289455 0
Australia
Date submitted for ethics approval [3] 289455 0
Approval date [3] 289455 0
02/07/2014
Ethics approval number [3] 289455 0
Ethics committee name [4] 289456 0
University of Melbourne Behavioural & Social Sciences Human Ethics SubCommittee
Ethics committee address [4] 289456 0
Ethics committee country [4] 289456 0
Australia
Date submitted for ethics approval [4] 289456 0
Approval date [4] 289456 0
10/10/2013
Ethics approval number [4] 289456 0
Ethics committee name [5] 289457 0
Curtin University of Technology Human Research Ethics Committee
Ethics committee address [5] 289457 0
Ethics committee country [5] 289457 0
Australia
Date submitted for ethics approval [5] 289457 0
Approval date [5] 289457 0
04/03/2014
Ethics approval number [5] 289457 0

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

Contacts
Principal investigator
Name 40734 0
Prof Meg Morris
Address 40734 0
School of Allied Health
Faculty of Health Sciences
La Trobe University
Bundoora
Victoria, 3086.
Country 40734 0
Australia
Phone 40734 0
+61 3 94796080
Fax 40734 0
+61 3 9479 5768
Email 40734 0
m.morris@latrobe.edu.au
Contact person for public queries
Name 40735 0
Joanne Wittwer
Address 40735 0
Physiotherapy Department
Faculty of Health Sciences
La Trobe University
Bundoora
Victoria, 3086.
Country 40735 0
Australia
Phone 40735 0
+61 3 94795808
Fax 40735 0
Email 40735 0
J.Wittwer@latrobe.edu.au
Contact person for scientific queries
Name 40736 0
Cathy Said
Address 40736 0
Austin Health,
PO Box 5444,
Heidelberg West,
VIC 3081
Country 40736 0
Australia
Phone 40736 0
+61 3 9496 2055
Fax 40736 0
Email 40736 0
cathy.said@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Permission for this was not sought in original ethics application


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
175Study protocol    Said CM, Morris ME, McGinley JL, Szoeke C, Workman... [More Details]
176Statistical analysis plan    See supplementary data Said CM, Morris ME, McGinl... [More Details]



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEvaluating the effects of increasing physical activity to optimize rehabilitation outcomes in hospitalized older adults (MOVE Trial): Study protocol for a randomized controlled trial.2015https://dx.doi.org/10.1186/s13063-014-0531-y
N.B. These documents automatically identified may not have been verified by the study sponsor.