ANZCTR - Registration

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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]

NIL KNOWN

Universal Trial Number (UTN)

Trial acronym

SuNBEAm trial

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Falls

Mobility and balance

Fear of falling and cognition

Condition category

Condition code

Physical Medicine / Rehabilitation

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]

Prevention

Intervention code [2]

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]

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]

Measured monthly for 12 months

Secondary outcome [1]

Quality of life - Measured by the SF-36 & EQ-5D-5L

Timepoint [1]

Measured at 6 and 12 months

Secondary outcome [2]

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]

Measured at 6 and 12 months

Secondary outcome [3]

Fear of falling - Falls Efficacy Scale – international (FES-I)

Timepoint [3]

Measured at 6 and 12 months

Secondary outcome [4]

Cognition - The Addenbrooke’s Cognitive Examination-R (ACE-R)

Timepoint [4]

Measured at 6 and 12 months

Secondary outcome [5]

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]

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

Sex

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

31/07/2012

Actual

31/07/2012

Date of last participant enrolment

Anticipated

31/07/2016

Actual

18/03/2015

Date of last data collection

Anticipated

Actual

30/03/2016

Sample size

Target

300

Accrual to date

Final

221

Recruitment in Australia

Recruitment state(s)

NSW,QLD

Funding & Sponsors

Funding source category [1]

University

Name [1]

The University of Sydney

Address [1]

Faculty of Health Sciences
75 East Street
LIDCOMBE NSW 2141

Country [1]

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]

University

Name [1]

University of Technology, Sydney.

Address [1]

Dr Stephen Goodall
University of Technology, Sydney.
Centre for Health Economic Research and Evaluation
PO Box 123
BROADWAY NSW 2007

Country [1]

Australia

Secondary sponsor category [2]

University

Name [2]

University of Queensland

Address [2]

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]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Sydney Human Research Ethics Committee

Ethics committee address [1]

Level 6, Jane Foss Russell Building - G02
The University of Sydney
NSW 2006 AUSTRALIA

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

17/07/2012

Ethics approval number [1]

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

Prof Kathryn Refshauge

Address

The University of Sydney
Office of the Dean
Faculty of Health Sciences
75 East Street
LIDCOMBE NSW 2141
AUSTRALIA

Country

Australia

Phone

+61 2 9351 9222

Fax

+61 2 9351 9688

kathryn.refshauge@sydney.edu.au

Contact person for public queries

Name

Jennifer Hewitt

Address

Room A203
Faculty of Health Sciences
The University of Sydney
75 East Street
LIDCOMBE NSW 2141
AUSTRALIA

Country

Australia

Phone

+61 427 226 045 OR +61 2 9036 7305

Fax

+61 2 9351 9688

jhew4562@uni.sydney.edu.au

Contact person for scientific queries

Name

Jennifer Hewitt

Address

Room A203
Faculty of Health Sciences
The University of Sydney
75 East Street
LIDCOMBE NSW 2141
AUSTRALIA

Country

Australia

Phone

+61 427 226 045 OR +61 2 9351 9000

Fax

+61 2 9351 9688

jhew4562@uni.sydney.edu.au

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

Source	Title	Year of Publication	DOI
Embase	Progressive Resistance and Balance Training for Falls Prevention in Long-Term Residential Aged Care: A Cluster Randomized Trial of the Sunbeam Program.	2018	https://dx.doi.org/10.1016/j.jamda.2017.12.014
Embase	Sunbeam Program Reduces Rate of Falls in Long-Term Care Residents With Mild to Moderate Cognitive Impairment or Dementia: Subgroup Analysis of a Cluster Randomized Controlled Trial.	2022	https://dx.doi.org/10.1016/j.jamda.2022.01.064

N.B. These documents automatically identified may not have been verified by the study sponsor.

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