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Trial registered on ANZCTR


Registration number
ACTRN12613000179730
Ethics application status
Approved
Date submitted
7/02/2013
Date registered
13/02/2013
Date last updated
17/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exercise for falls prevention in residential aged care
Scientific title
Resistance and balance exercise in residential aged care for falls prevention
Secondary ID [1] 281858 0
NIL KNOWN
Universal Trial Number (UTN)
Trial acronym
SuNBEAm trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls 288222 0
Mobility and balance 288224 0
Fear of falling and cognition 288311 0
Condition category
Condition code
Physical Medicine / Rehabilitation 288587 288587 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Progressive resistance training (PRT) and balance exercise for residents of Aged Care Facilities. Dosage is two one hour classes per week for 6 months using pneumatic resistance equipment and closely supervised high level balance exercise. PRT will target: hip and knee flexors and extensors, abdominals, back extensors, hip abductors, hip adductors, elbow and shoulder flexors and extensors. Exercise will be individually prescribed and upgraded an exercise professional (physiotherapist or exercise physiologist) to enable participants to achieve 2-3 sets of 10-15 repetitions for each exercise. Balance exercises will include a combination of heel raises, stepping in different directions, reaching outside the base of support, single leg standing, step ups and balance platform work.

A maintenance program including balance, weight-bearing and functional exercises will continue for the next 6 months. Sessions will be supervised by a diversional therapist or physiotherapy assistant and run twice per week for 20 minutes.
Intervention code [1] 286418 0
Prevention
Intervention code [2] 286505 0
Lifestyle
Comparator / control treatment
Usual care - participants continue with their usual (pre-inclusion) activities for the 12 month study period but are requested not to commence a resistance or balance program during this time. Examples of such activities may include participation in games or other interests as part of the diversional therapy program within the aged care facility.
Control group
Active

Outcomes
Primary outcome [1] 288741 0
Falls - defined as the number of fallers and the number of falls for each participant.
This will be measured monthly for 12 months by auditing both daily progress notes and incident forms kept at the aged care facility.
Participants will also be asked at the time of the 6 and 12 month assessments if they have fallen since they were last assessed.
Timepoint [1] 288741 0
Measured monthly for 12 months
Secondary outcome [1] 300877 0
Quality of life - Measured by the SF-36 & EQ-5D-5L
Timepoint [1] 300877 0
Measured at 6 and 12 months
Secondary outcome [2] 300878 0
Mobility - 1) The short physical performance battery (SPPB) will be used to evaluate, balance, gait, strength, and endurance; 2) The Step Test will be used to assess dynamic balance and agility; and 3) The University of Alabama – Life Space Assessment (UAB-LSA) will be used to assess the extent of mobility and frequency of movement along with any assistance needed
Timepoint [2] 300878 0
Measured at 6 and 12 months
Secondary outcome [3] 300879 0
Fear of falling - Falls Efficacy Scale – international (FES-I)
Timepoint [3] 300879 0
Measured at 6 and 12 months
Secondary outcome [4] 300880 0
Cognition - The Addenbrooke’s Cognitive Examination-R (ACE-R)
Timepoint [4] 300880 0
Measured at 6 and 12 months
Secondary outcome [5] 300881 0
Cost effectiveness - The incremental cost-effectiveness ratio will also be calculated relative to the control group (cost per quality of life year - QALY). To perform this analysis the health benefits associated with the program will be estimated using the SF-36
Timepoint [5] 300881 0
Measured at 12 months and extended to estimated lifetime of participant lifespan.

Eligibility
Key inclusion criteria
Permanent residents of aged care facilities.
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Terminal or unstable illness; significant advanced cognitive decline (that precludes safely following direction for exercise and equipment use); advanced Parkinson's Disease or severe hemiplegia (that precluded inclusion in group exercise); permanently wheel chair or bed bound; or have performed a similar balance and/or resistance training program in the past 12 months; insufficient English to complete outcome measures questionnaires.

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)
Concealed allocation via centralised computer generated cluster randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Cluster randomisation by aged care facility using a randomisation table 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
Analyses will be conducted at the participant level but appropriately adjusted for clustering of participants within aged care faciities using mixed models.
A logistic mixed model will be used to analyse the number of residents that fall during the study period (binary outcome). The number of falls (a count outcome) will be analysed using a Poisson mixed model.

The cost-effectiveness ($AUD) component will be presented as net costs and benefits for intervention and usual care aged care facilities. The cost of the intervention will be measured along with any cost-savings due to avoided health care utilisation. The incremental cost-effectiveness ratio will also be calculated relative to the control group (cost per quality of life year - QALY). To perform this analysis the health benefits associated with the program will be estimated using the SF-36 a preference-based single utility measure, using Australian preference weights, will be derived from these data.

Recruitment
Recruitment status
Completed
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 in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 286638 0
University
Name [1] 286638 0
The University of Sydney
Address [1] 286638 0
Faculty of Health Sciences
75 East Street
LIDCOMBE NSW 2141
Country [1] 286638 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Prof Kathryn Refshauge, Prof Lindy Clemson, Jennifer Hewitt
c/o Arthritis and Musculo-skeletal Research Laboratory
A203
Faculty of Health Sciences
75 East Street
LIDCOMBE NSW 2141
Country
Australia
Secondary sponsor category [1] 285420 0
University
Name [1] 285420 0
University of Technology, Sydney.
Address [1] 285420 0
Dr Stephen Goodall
University of Technology, Sydney.
Centre for Health Economic Research and Evaluation
PO Box 123
BROADWAY NSW 2007
Country [1] 285420 0
Australia
Secondary sponsor category [2] 285421 0
University
Name [2] 285421 0
University of Queensland
Address [2] 285421 0
Dr Tim Henwood
University of Queensland/Blue Care Research & Practice Development Centre
School of Nursing and Midwifery
56 Sylvan Rd
Toowong QLD 4066

Country [2] 285421 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288714 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 288714 0
Level 6, Jane Foss Russell Building - G02
The University of Sydney
NSW 2006 AUSTRALIA
Ethics committee country [1] 288714 0
Australia
Date submitted for ethics approval [1] 288714 0
Approval date [1] 288714 0
17/07/2012
Ethics approval number [1] 288714 0
14995

Summary
Brief summary
Falls are common in the population aged 65 years and over and present a major challenge to older people, health care providers and the health system. Over one third of community dwelling people in this age group fall each year and the rate of falling is even higher in residents of aged care facilities. There is now extensive evidence to demonstrate fall rates can be reduced using exercise. Programs that target balance and lower limb muscle strength appear to be most successful however the vast majority of research has focused on community dwelling adults. The results of trials into exercise on falls prevention in residential care are inconsistent. This randomized controlled trial will test the efficacy of an exercise intervention that combines key components of programs from successful community based research on residents of long term aged care. The primary outcome will be falls (fall rates and number of fallers). Quality of life, mobility, and fear of falling will also be measured and a cost benefit analysis will be performed. Outcomes from this study have the potential to impact on a substantial individual and international healthcare problem.
Trial website
Trial related presentations / publications
1) Hewitt J, Goodall S, Clemson L, Henwood T, Refshauge K. (2018) Progressive resistance and balance training for falls prevention in long-term residential aged care: A cluster randomized trial of the Sunbeam Program. JAMDA (19): 361-369.
2) Hassan B, Hewitt J, Henwood T et al. (2016) Impact of resistance training on sarcopenia in nursing care facilities: a pilot study. Geriatr Nur 32(2): 116-121
3) Hewitt J, Refshauge K, Henwood T, Goodall S, Clemson L. (2014) “Does progressive resistance and balance exercise reduce falls in residential aged care? Randomised controlled trial protocol for “The Sunbeam” Program. Clinical Interventions in Aging (9) 369-376.
4) Hewitt J, Refshauge K, Henwood T, Goodall S, Clemson L. (2013) “Falls Prevention Research in residential aged care is itself tripped up by medical clearance issues”. Australasian Journal of Ageing (32)(4) p 247.
5) Hewitt J, Refshauge K, Henwood T, Goodall S, Clemson L. Falls prevention and quality of life in residential aged care: using exercise to grow bold not old. JAPA 2016; (24): Supp: S21.
6) Henwood T, Keogh J, Senior S, Hewitt J. Sarcopenia in the aged care setting: Prevalence, Consequences and the impact of resistance training. JAPA 2016; (24): Supp: S8-9.
Conference Presentations - podium
7) November 2012 ERA (Emerging Researchers in Ageing), Brisbane.
“Falls prevention in residential aged care: Making an impact by averting impact”
8) May 2013 3rd Biennial National Falls Prevention Summit, Brisbane.
“Falls prevention in residential aged care: The research and its practical application.”
9) November 2013 ERA, Sydney. “Enabling active ageing in residential aged care”.
10) November 2014 Sydney Medical School Anniversary Event, Sydney.
“Exercise for falls prevention in residential aged care.”
11) May 2016 NSW Falls Prevention Network Forum, Sydney. “Exercise for falls prevention in residential aged care”
12) June 2016 World Congress on Active Ageing, Melbourne.
“Falls prevention and quality of life in residential aged care: Using exercise to grow bold not old.”
13) November 2016 Australian Association of Gerontologists Annual Conference, Canberra.
“Re-imagining physiotherapy in residential aged care: Exercise, falls prevention, re-ablement.”
14) October 2017 Australian Physiotherapy Association National Conference, Sydney.
“Challenging physiotherapy in residential aged care: Moving away from pain management to exercise, falls prevention, and re-ablement.”
15) May 2018 NSW Falls Prevention Network Forum, Sydney. Exercise for the prevention of falls in residential aged care - results of the Sunbeam trial.
Public notes

Contacts
Principal investigator
Name 37418 0
Prof Kathryn Refshauge
Address 37418 0
The University of Sydney
Office of the Dean
Faculty of Health Sciences
75 East Street
LIDCOMBE NSW 2141
AUSTRALIA


Country 37418 0
Australia
Phone 37418 0
+61 2 9351 9222
Fax 37418 0
+61 2 9351 9688
Email 37418 0
kathryn.refshauge@sydney.edu.au
Contact person for public queries
Name 37419 0
Ms Jennifer Hewitt
Address 37419 0
Room A203
Faculty of Health Sciences
The University of Sydney
75 East Street
LIDCOMBE NSW 2141
AUSTRALIA

Country 37419 0
Australia
Phone 37419 0
+61 427 226 045 OR +61 2 9036 7305
Fax 37419 0
+61 2 9351 9688
Email 37419 0
jhew4562@uni.sydney.edu.au
Contact person for scientific queries
Name 37420 0
Ms Jennifer Hewitt
Address 37420 0
Room A203
Faculty of Health Sciences
The University of Sydney
75 East Street
LIDCOMBE NSW 2141
AUSTRALIA
Country 37420 0
Australia
Phone 37420 0
+61 427 226 045 OR +61 2 9351 9000
Fax 37420 0
+61 2 9351 9688
Email 37420 0
jhew4562@uni.sydney.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary