Please note that the ANZCTR website will be unavailable from 12am until 6am (AEST) on Sunday 22nd September 2019. Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618001827224
Ethics application status
Approved
Date submitted
1/11/2018
Date registered
9/11/2018
Date last updated
2/04/2019
Date data sharing statement initially provided
9/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Staying UpRight in Residential Care: An exercise program for older people living in residential care designed to reduce rates of falls
Scientific title
Staying UpRight in Residential Care: An exercise program for older people living in residential care designed to reduce rates of falls
Secondary ID [1] 296489 0
Funding HRC project ref 18/414
Universal Trial Number (UTN)
U1111-1217-7148

Trial acronym
SUiRC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls
310271 0
Dementia 310272 0
Condition category
Condition code
Injuries and Accidents 309003 309003 0 0
Fractures
Injuries and Accidents 309004 309004 0 0
Other injuries and accidents
Neurological 309005 309005 0 0
Dementias
Physical Medicine / Rehabilitation 309006 309006 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
"Staying UpRight" is a strength, power and balance program, delivered in 1 hour sessions, twice weekly over 1 year. It is a group program (approximately 8 residents per group), delivered by one physiotherapist and one assistant.
Strength training uses low repetitions, moderate-high resistance (2 x 10 repetitions at 5-7/10 effort) in weight-bearing positions (e.g. lunges, squats, sit to stand, heel raises) progressed by increasing the speed and/or depth of the movement (e.g. deeper lunges). Balance training comprises static and dynamic activities (e.g. tandem and one legged stand, reaching, stepping, walking, and turning) and is progressed by reducing hand support, reducing the base of support, reducing visual input; and adding a cognitive task. For example, walking on the spot on toes and heels is progressed to walking on toes and heels forwards, backwards and sideways; and stepping over obstacles.
The program is manualised and includes instruction on exercise delivery and exercise progression. Exercises completed in each session, and exercise progressions for the group are recorded on a spreadsheet, in addition to a participant attendance record.
The active control program, led by an activities coordinator, uses only seated activities (no standing component), ‘light’ work (<5/10) with no resistance exercises and no progressions. Activities focus on seated movement and variety e.g. seated upper and lower limb activities; seated boxing, seated marching, heel and toe tapping; seated upper and lower limb stretches using non elastic bands and games e.g. seated scarf catch and throw, pass the parcel.

Fidelity of program delivery will be checked during the first 6 months (of physiotherapist delivery) and the second 6 months (of facility staff member delivery) through:
a. A site visit from the project manager within the first 2 months of each 6-month block, which entails observation of a class taking place. Feedback is given as necessary to the physiotherapist or facility staff member to ensure fidelity of intervention delivery. Any actions expected in response to the feedback will be monitored via telephone calls and visits as required.
b. A monthly audit of the spreadsheets used to record each participant’s exercises by the physiotherapist research team member (who initially trained the research physiotherapists to check the class content). If violations in the exercise program are noted, the physiotherapist research team member will contact the delivering physiotherapist or facility staff member and discuss the issues to a satisfactory resolution.
c. All observed or noted episodes of program fidelity violations will be recorded and reviewed monthly by the research physiotherapy team members.
Intervention code [1] 312811 0
Prevention
Intervention code [2] 312812 0
Rehabilitation
Comparator / control treatment
Participants in the comparator arm of the trial will receive a supervised group exercise program (approx. 8 residents per group). The “Flex and Stretch” activity program comprises only seated activities, stretches and movements at low intensity (< 5/10 effort) with no resistance component. The program is dose-matched to the intervention and delivered for 1 hour twice a week for 1 year.
An activities coordinator trained in the program will deliver the program for the first 6 months. In the fifth month, a volunteer will engage, learn the program and take over delivery for the second 6 months. Support for the volunteer from the physiotherapy research team member will remain available over the second 6 months. The programme is manualised and includes instruction on exercise delivery. An attendance record for all participants will be kept throughout the trial.

The fidelity of the comparator programme will be checked during the first 6 months (of research assistant delivery) and the second 6 months (of volunteer delivery) by a site visit from the project manager within the first 2months of each 6- month block, which entails observation of a class taking place. Feedback will be provided to the research assistant or volunteer to ensure fidelity of intervention delivery.
Controlling contamination between intervention and comparator groups within a single care-home facility will be managed by separating the delivery of the class from non-enrolled residents, using non-public areas for the classes, and using different facilitators for the different classes.
Control group
Active

Outcomes
Primary outcome [1] 307965 0
Rate of falling expressed as number of falls per thousand person-years of follow-up.
Timepoint [1] 307965 0
Continuous monitoring of care home accident / incident fall registers for the 6 months prior to study commencement (to provide baseline data) and at 12 months after intervention commencement at the facility
Secondary outcome [1] 353502 0
Risk of falling expressed as time to first fall.
Timepoint [1] 353502 0
Continuous monitoring of care home accident / incident fall registers for the 6 months prior to study commencement (to provide baseline data) and at 12 months after intervention commencement at the facility
Secondary outcome [2] 353504 0
Fall-free activity time expressed as falls rate per minutes of ambulatory activity, measured using validated algorithms for body-worn accelerometers.
Timepoint [2] 353504 0
Baseline prior to randomization, 6 months and at 12 months after after intervention commencement at the facility
Secondary outcome [3] 353505 0
Rates of hospitalisation for fall-related injury (fracture, intracranial or extracranial haemorrhage) expressed as number of fall hospitalisations per thousand person years of follow-up
Timepoint [3] 353505 0
Continuous monitoring of care home accident / incident fall registers for the 6 months prior to study commencement (to provide baseline data) and at 12 months after intervention commencement at the facility
Secondary outcome [4] 353506 0
Change in gait variability: a composite measure using accelerometer algorithms valid for 14 spatio-temporal features of gait
Timepoint [4] 353506 0
Baseline prior to randomization, 6 months and at 12 months after intervention commencement at the facility
Secondary outcome [5] 353507 0
Change in total volume (time) and pattern of ambulatory activity (a composite measure of ambulatory bout length, accumulation of bouts, distribution of bouts ) expressed as number of non-sedentary hours of follow-up per thousand person-years of follow-up, assessed using body-worn accelerometers
Timepoint [5] 353507 0
Baseline prior to randomization, 6 months and at 12 months after intervention commencement at the facility
Secondary outcome [6] 353508 0
Change in cognition, assessed using Montreal Cognitive Assessment scores
Timepoint [6] 353508 0
Baseline prior to randomization, 6 months and at 12 months after facility intervention commencement.
Secondary outcome [7] 353509 0
Cost effectiveness of program expressed as the ratio of estimated total cost of program against estimated total savings in hospitalisation costs. Use of healthcare resources will be obtained using NHIs from national databases (National Minimum Dataset and National Non-Admitted Patients Collection) and care home records (including intervention details). Unit costs will be assigned using Weighted Inlier Equivalent Separations NZ, indicative District Health Board costs for outpatients.
Timepoint [7] 353509 0
On completion of interventions at all facilities
Secondary outcome [8] 353775 0
Change in Short Performance Physical Battery (mobility) component scores
Timepoint [8] 353775 0
Baseline prior to randomization, 6 months and at 12 months after intervention commencement at the facility
Secondary outcome [9] 353776 0
Change in Timed Up and Go (mobility) scores
Timepoint [9] 353776 0
Baseline prior to randomisation, 6 months and at 12 months after intervention commencement at the facility

Eligibility
Key inclusion criteria
Residents living in participating aged-care facilities, who are 65 years of age and over, mobile with or without cognitive deficit
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Residents in respite care, in the palliative stage of life, extremely unwell, bedbound or in hospital-level psychogeriatric care.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A researcher, "off site" and unconnected to recruitment will create the randomisation list using a computer to generate pseudo-random numbers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation within each facility, using computerised sequence generation. Stratified by resident level of care (high or low dependency) within each facility
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)
Safety/efficacy
Statistical methods / analysis
The sample size is estimated on the primary outcome, falls rate. To detect a 25% reduction in falls, assuming a control rate of 2.6 falls per resident per year (based on pilot data), we estimate a required sample size of 264 in each group (528 total; two-tailed test, (a=0.05, power= 90%). The anticipated drop-out rate is 35%, which will be replaced by recruitment at participating facilities throughout the trial. Final recruitment in each facility will stop 12 weeks prior to completion of the 12 month intervention at each facility.
The sample size is estimated on the primary outcome, falls rate. To detect a 25% reduction in falls, assuming a control rate of 2.6 falls per resident per year (based on pilot data), we estimate a required sample size of 264 in each group (528 total; two-tailed test, a=0.05, power= 90%). The anticipated drop-out rate is 35%, which will be replaced by recruitment at participating facilities throughout the trial.
Data analysis
1. Total number of falls, number of fallers, people sustaining a fall-related fracture or brain injury; rate of falls (falls per person year); multiple fallers and number in each analysis will be reported.
2. Prior fall-incidence rates, calculated as number of falls/ resident/ year using the audited six months prior to enrolment. Negative binomial regression models will be fitted to determine the Incident Rate Ratio (IRR) between groups. Logistic regression methods will be used for risk of falls, and linear regression for fall free activity. All models will control for prior falls rate, level of dependency, cognition (Montreal Cognitive Assessment [MoCA]) and functional status (interRAI™ clinical assessment data; Short Performance Physical Battery; Timed Up and Go).
3. Falls rate per minutes of ambulatory activity will be calculated. Associations between ambulatory activity volumes and patterns (bout length), spatiotemporal gait parameters, falls rate, cognitive status and functional status will be explored using bivariate and regression analysis. Cox regression will identify predictors of activity-adjusted falls risk. Change in ambulation volumes and patterns (bout length) and spatiotemporal gait parameters will be reported for the intervention group using comparator group data as reference
4. Analysis of ambulatory activity (derived from accelerometer data) will include (i) summary measures (volume, pattern and variability of walking bout duration) and (ii) discreet gait characteristics (mean and variability of gait velocity, step length, step time, step symmetry). Comparison of change over time in gait variability between the intervention and comparator groups will be undertaken using regression techniques.
5. Gait parameters will be examined as a function of cognitive level and specifically each of the 14 spatio-temporal features including gait speed and gait variability will be mapped against cognitive function and functional status. Range of gait parameters will be described and compared between those with normal cognition, mild, moderate and severe cognitive decline using regression techniques examining amount of activity as a moderator of change. Change over time will be examined; natural history of gait change will be estimated from the active intervention (“flex and stretch”) group data.
6. Cost effectiveness. Unit costs will be assigned using WIESNZ weights, indicative DHB costs for outpatients, and literature/expert judgement for anything not already covered. Incremental cost effectiveness for intervention versus comparator activity will be assessed (i) per fall prevented and (ii) per injury fall (resulting in hospitalisation) prevented. The cost-effectiveness of Staying UpRight as an adjunct to usual activity will be explored for these same outcomes by removing the costs of the comparator activity (retaining any effect). Sensitivity analyses will be performed for all analyses to indicate the uncertainty in our estimation of the costs and consequences using bootstrapping. Decision uncertainty will be assessed using a probabilistic sensitivity analysis using standard diagrams (CEACS/CEAFs) and varying assumptions around care home size.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 20984 0
New Zealand
State/province [1] 20984 0

Funding & Sponsors
Funding source category [1] 301076 0
Government body
Name [1] 301076 0
Health Research Council
Address [1] 301076 0
PO Box 5541, Wellesley Street,
Auckland 1141
New Zealand
Country [1] 301076 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Private Bag 92019
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 300685 0
University
Name [1] 300685 0
Auckland University of Technology
Address [1] 300685 0
Private Bag 92006
Auckland 1142
Country [1] 300685 0
New Zealand
Other collaborator category [1] 280415 0
University
Name [1] 280415 0
Newcastle University
Address [1] 280415 0
Newcastle upon Tyne NE1 7RU
Country [1] 280415 0
United Kingdom
Other collaborator category [2] 280416 0
Hospital
Name [2] 280416 0
Robert Bosch Krankenhaus
Address [2] 280416 0
Auerbachstraße 110, 70376 Stuttgart
Country [2] 280416 0
Germany

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301830 0
Health and Disability Ethics Committees
Ethics committee address [1] 301830 0
Ministry of Health
PO Box 5013
Wellington, 6011
Ethics committee country [1] 301830 0
New Zealand
Date submitted for ethics approval [1] 301830 0
20/08/2018
Approval date [1] 301830 0
31/10/2018
Ethics approval number [1] 301830 0
18/NTB/151

Summary
Brief summary
Older people fall frequently in residential aged care with disastrous consequences including injury and hospitalisation. Preventing falls in care homes has been difficult. This project tests an exercise programme specifically designed for aged care residents, including those with dementia in comparison to seated exercises, to see if falls and injury from falls can be prevented. A novel feature of this study is body-worn sensor monitoring of participants to establish gait parameters and activity patterns. Amount of activity will be used as an outcome for the trial, falls/active time, and gait patterns and parameters will be examined between those with and without dementia and in response to the programme.. Cost-effectiveness analyses will see whether there is a return on investment. If this exercise programme is successful, those in care homes will benefit and costs will be saved.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88250 0
Prof Ngaire Kerse
Address 88250 0
School of Population Health,
The University of Auckland
Private Bag 92019
Auckland 1142
Country 88250 0
New Zealand
Phone 88250 0
+64 9 373 7999
Fax 88250 0
Email 88250 0
n.kerse@auckland.ac.nz
Contact person for public queries
Name 88251 0
Prof Ngaire Kerse
Address 88251 0
School of Population Health,
The University of Auckland
Private Bag 92019
Auckland 1142
Country 88251 0
New Zealand
Phone 88251 0
+64 9 373 7999
Fax 88251 0
Email 88251 0
n.kerse@auckland.ac.nz
Contact person for scientific queries
Name 88252 0
Prof Ngaire Kerse
Address 88252 0
School of Population Health,
The University of Auckland
Private Bag 92019
Auckland 1142
Country 88252 0
New Zealand
Phone 88252 0
+64 9 373 7999
Fax 88252 0
Email 88252 0
n.kerse@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
Summary results
No Results