Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000865516
Ethics application status
Approved
Date submitted
30/06/2015
Date registered
19/08/2015
Date last updated
31/07/2019
Date data sharing statement initially provided
31/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Balance Exercise and Strength Training (BEST) program for older people living at home
Scientific title
Lower limb home-based exercise program compared with upper limb home-based exercise program to prevent falls and upper limb dysfunction in older community-dwelling people: a randomised controlled trial.
Secondary ID [1] 286103 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls injuries in older people 294104 0
Upper limb dysfunction in older people 295010 0
Condition category
Condition code
Injuries and Accidents 294417 294417 0 0
Fractures
Musculoskeletal 295273 295273 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 296156 296156 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The lower limb group will receive a home-based exercise program for the lower limb. This program is based on the Otago Exercise Program, which has been found to reduce rates of falls and injurious falls. The lower limb exercise program includes balance and strength exercises for example sit to stand, semi squats from a standing position, calf raises, toe raises, sideways walking, backwards walking and one leg stand.

The exercise instruction will be delivered by an experienced physiotherapist in three group workshops (approximately one hour each). Exercise instruction workshops will occur at weeks 1, 4 and 12. Participants will be encouraged to perform the set of exercises three times per week at home for a period of 12 months. The set of exercises should take 20-30 minutes to complete. The weight to be used at the beginning of the program and progression of exercise intensity will be individualised and determined by the physiotherapists. The exercises are to be completed with good technique and control. Once exercises can be performed comfortably, they are progressed by increasing weight and/or decreasing the support.

Participants will be provided with an ankle weight and a home exercise manual which contains clear pictures and descriptions of the exercises, and booklet about preventing falls. Participants will also be provided with a calendar to record their exercises and falls on a monthly basis. Participants will be asked to return their calendars to the research team at the end of each month in the supplied reply paid envelopes. Participants will receive a 5-10 minute booster phone call, by a member of the research team, at nine months after participation commencement.
Intervention code [1] 291095 0
Prevention
Intervention code [2] 291096 0
Lifestyle
Intervention code [3] 291097 0
Behaviour
Comparator / control treatment
The upper limb group will receive an exercise program designed to improve upper limb function. The exercise instruction will be delivered by an experienced physiotherapist in three group workshops (approximately one hour each). Exercise instruction workshops will occur at weeks 1, 4 and 12. Participants will be taught exercises such as shoulder raises, shoulder rotation, elbow flexion and extension, and rowing exercises.

Participants will be encouraged to perform the set of exercises three times per week at home for a period of 12 months. The set of exercises should take 20-30 minutes to complete. The weight of the equipment to be used at the beginning of the program and progression of exercise intensity will be individualised and determined by the physiotherapists. The exercises are to be done with optimal scapula positioning and control. Exercises are progressed by increasing complexity (eg increased range, increased load, less support), that is, maintaining form as load and range is increased and support is decreased. This program has been developed by Investigators Associate Professor Karen Ginn and Dr Paul van den Dolder who are experts on shoulder anatomy and rehabilitation, and the research team.

Participants will be provided with weights, a theraband and a home exercise manual which contains clear pictures and descriptions of the exercises. Participants will also be provided with a calendar to record their exercises and falls on a monthly basis. Participants will be asked to return their calendars to the research team at the end of each month in the supplied reply paid envelopes. Participants will receive a 5-10 minute booster phone call, by a member of the research team, at nine months after participation commencement.
Control group
Active

Outcomes
Primary outcome [1] 294212 0
Rate of falls will be assessed by monthly calendars and telephone calls.
Timepoint [1] 294212 0
The number of falls in the 12 months after randomisation.
Primary outcome [2] 294716 0
Upper limb function will be assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire.
Timepoint [2] 294716 0
Baseline and 12 months after randomisation.
Secondary outcome [1] 312779 0
Strength and balance will be assessed with the Short Physical Performance Battery (which is a composite measure including sit to stand, timed walk and standing balance).
Timepoint [1] 312779 0
Baseline, 12 weeks and 26 weeks after randomisation.
Secondary outcome [2] 312780 0
Upper limb function will be assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire.
Timepoint [2] 312780 0
12 weeks and 26 weeks after randomisation.
Secondary outcome [3] 312781 0
Physical Activity will be assessed using the Incidental and Planned Exercise Questionnaire.
Timepoint [3] 312781 0
Baseline, 12 weeks, 26 weeks and 12 months after randomisation.
Secondary outcome [4] 312782 0
Falls efficacy will be assessed with the short version of the Falls Efficacy Scale-International.
Timepoint [4] 312782 0
Baseline, 12 weeks, 26 weeks and 12 months after randomisation.
Secondary outcome [5] 312783 0
Quality of life will be assessed using the Short Form 12-item health survey (SF12v2).
Timepoint [5] 312783 0
Baseline, 12 weeks, 26 weeks and 12 months after randomisation.
Secondary outcome [6] 312784 0
Attitudes to exercise will be assessed by selected questions from the Physical Activity Stages of Change questionnaire, the Exercise Self-efficacy Scale and the Physical Activity Enjoyment Scale.
Timepoint [6] 312784 0
Baseline, 12 weeks, 26 weeks and 12 months after randomisation.
Secondary outcome [7] 312785 0
Physical Activity Data will be collected using an accelerometer (Actigraph) over a 7 day period.
Timepoint [7] 312785 0
Baseline, 26 weeks and 12 months after randomisation.
Secondary outcome [8] 312853 0
Health and community service use as assessed by monthly calendars and telephone calls.
Timepoint [8] 312853 0
12 months after randomisation.
Secondary outcome [9] 313723 0
Lower limb strength will be assessed with quadriceps strength test by a digital weight scale.
Timepoint [9] 313723 0
Baseline, 12 weeks and 26 weeks after randomisation.
Secondary outcome [10] 313724 0
Balance will be assessed with the alternate step test.
Timepoint [10] 313724 0
Baseline, 12 weeks and 26 weeks after randomisation.
Secondary outcome [11] 313727 0
Shoulder strength will be assessed by isometric shoulder internal and external rotation force (left and right) using a dynamometer.
Timepoint [11] 313727 0
Baseline, 12 weeks and 26 weeks after randomisation.
Secondary outcome [12] 313728 0
Shoulder mobility will be assessed by active shoulder internal and external rotation range of motion (left and right) using an inclinometer.
Timepoint [12] 313728 0
Baseline, 12 weeks and 26 weeks after randomisation
Secondary outcome [13] 313786 0
The proportion of fallers in the intervention and comparator groups as assessed by monthly calendars and telephone calls.
Timepoint [13] 313786 0
12 months after randomisation.

Eligibility
Key inclusion criteria
People aged 65 years and over, and living at home or independently in the community (eg self care unit in residential aged care facility) in the Illawarra Shoalhaven Local Health District.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Residing in nursing home; cognitive impairment (Memory Impairment Screen score less than 5); inability to walk 10 metres despite assistance from walking aid; insufficient English language skills; a progressive neurological disease eg Parkinson’s disease; recent fracture/joint replacement; a medical condition precluding exercise eg unstable cardiac disease, uncontrolled hypertension, uncontrolled metabolic diseases; unable to obtain a medical clearance; currently participating in an exercise program similar to either study program two or more times per week.

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)
The project officer will screen for inclusion/exclusion criteria. Informed consent and medical clearance will be collected. Once there are enough people for a group, the baseline assessments and questionnaires will be completed. The person will then be randomised (the group allocation will be obtained through the REDCap database) into the lower limb exercise group or into the upper limb exercises group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomly ordered blocks, organised by investigator not involved in the recruitment and uploaded to REDCap.
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
Efficacy
Statistical methods / analysis
Linear regression models will be used to assess the effect of group allocation on the continuously-scored primary (DASH questionnaire) and secondary outcome measures (strength, balance, physical activity, quality of life, fear of falling, upper limb pain and function, shoulder internal and external rotation force and range of movement, health and community service use), after adjusting for baseline scores. The number of falls per person-year will be analysed using negative binomial regression models to estimate the between-group difference in fall rates after one year (primary outcome).Modified Poisson regression models will be used to compare groups on dichotomous outcome measures (proportion of fallers, proportion meeting physical activity guidelines).

The required sample size of 576 will provide 80% power to detect as significant, at the 5% level, a 30% lower rate of falls for intervention group participants than control participants (i.e., IRR = 0.70). Sample size calculations used the gennbreg command in Stata 13 and coefficients from previous studies: alpha (a measure of over-dispersion in the negative binomial regression model) was assumed to be 0.8 based on a previous RCT in a similar population (Clemson et al, 2004). We assumed the control group rate of falls to be 0.85 falls/person year over the 12- month follow-up, which is comparable with the fall rates found in similar trials with community based samples (Sherrington et al, 2008). The 0.70 value for IRR was chosen as this is comparable to the size of the effect on the rate of falls from other exercise interventions (Sherrington et al, 2008). This sample size will also be sufficient to detect a 30% reduction in the proportion of fallers (control proportion of fallers 40%, intervention group proportion of fallers 28%) with 80% power and 15% loss to follow-up.

576 participants will also be sufficient to detect a 10% between-group difference in secondary physical outcomes such as Short Physical Performance Battery (power= 90%, p= 0.05, SD=0.69, control group mean score score=0.178).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/09/2015
Actual
26/10/2015
Date of last participant enrolment
Anticipated
Actual
5/06/2017
Date of last data collection
Anticipated
30/06/2018
Actual
5/06/2018
Sample size
Target
576
Accrual to date
Final
617
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 290682 0
Government body
Name [1] 290682 0
National Health and Medical Research Council
Country [1] 290682 0
Australia
Primary sponsor type
Individual
Name
Professor Cathie Sherrington
Address
The University of Sydney
Musculoskeletal Health Sydney, School of Public Health
Level 10 North, King George V Building
Royal Prince Alfred Hospital (C39)

PO Box M179
MISSENDEN ROAD NSW 2050 Australia
Country
Australia
Secondary sponsor category [1] 289376 0
None
Name [1] 289376 0
Address [1] 289376 0
Country [1] 289376 0
Other collaborator category [1] 278317 0
Individual
Name [1] 278317 0
Dr Susan Furber
Address [1] 278317 0
Illawarra Shoalhaven Local Health District
Level 1, 67-71 King Street, Warrawong, NSW 2502

Postal address: Locked Bag 9, Wollongong NSW 2500
Country [1] 278317 0
Australia
Other collaborator category [2] 278318 0
Individual
Name [2] 278318 0
Professor Adrian Bauman
Address [2] 278318 0
School of Public Health
Sydney University NSW 2006
Country [2] 278318 0
Australia
Other collaborator category [3] 278319 0
Individual
Name [3] 278319 0
Professor Kirsten Howard
Address [3] 278319 0
University of South Australia, Institute for Choice
Level 13, 140 Arthur Street
North Sydney NSW 2060
Country [3] 278319 0
Australia
Other collaborator category [4] 278320 0
Individual
Name [4] 278320 0
Dr Anne Tiedemann
Address [4] 278320 0
The University of Sydney
Musculoskeletal Health Sydney, School of Public Health
Level 10 North, King George V Building
Royal Prince Alfred Hospital (C39)

PO Box M179
MISSENDEN ROAD NSW 2050 Australia
Country [4] 278320 0
Australia
Other collaborator category [5] 278321 0
Individual
Name [5] 278321 0
Dr Paul van den Dolder
Address [5] 278321 0
Illawarra Shoalhaven Local Health District
Level 1, 67-71 King Street, Warrawong, NSW 2502


Postal address: Locked Bag 9, Wollongong NSW 2500
Country [5] 278321 0
Australia
Other collaborator category [6] 278322 0
Individual
Name [6] 278322 0
Associate Professor Karen Ginn
Address [6] 278322 0
Discipline of Biomedical Science, School of Medical Sciences, Sydney Medical School, THE UNIVERSITY OF SYDNEY

S213, Cumberland Campus C42, East St (PO Box 170) Lidcombe, NSW, 1825
Country [6] 278322 0
Australia
Other collaborator category [7] 278323 0
Individual
Name [7] 278323 0
Ms Amanda Bates
Address [7] 278323 0
Illawarra Shoalhaven Local Health District
Level 1, 67-71 King Street, Warrawong, NSW 2502


Postal address: Locked Bag 9, Wollongong NSW 2500
Country [7] 278323 0
Australia
Other collaborator category [8] 278324 0
Individual
Name [8] 278324 0
Ms Lisa Franco
Address [8] 278324 0
Illawarra Shoalhaven Local Health District
Level 1, 67-71 King Street, Warrawong, NSW 2502


Postal address: Locked Bag 9, Wollongong NSW 2500
Country [8] 278324 0
Australia
Other collaborator category [9] 278325 0
Individual
Name [9] 278325 0
Ms Michelle Kershaw
Address [9] 278325 0
Illawarra Shoalhaven Local Health District
Level 1, 67-71 King Street, Warrawong, NSW 2502


Postal address: Locked Bag 9, Wollongong NSW 2500
Country [9] 278325 0
Australia
Other collaborator category [10] 278326 0
Individual
Name [10] 278326 0
Ms Patricia Lynch
Address [10] 278326 0
Health Promotion Service
Directorate Planning and Population Health
190 Russell Avenue, Dolls Point, NSW 2219
Country [10] 278326 0
Australia
Other collaborator category [11] 278328 0
Individual
Name [11] 278328 0
Ms Catherine Chittenden
Address [11] 278328 0
Physiotherapy Shoalhaven District Memorial Hospital
PO Box 246
Nowra 2541 NSW
Country [11] 278328 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292314 0
Joint University of Wollongong and Illawarra Shoalhaven Local Health District Health Medical Human Research Ethics Committee (EC00150)
Ethics committee address [1] 292314 0
Ethics committee country [1] 292314 0
Australia
Date submitted for ethics approval [1] 292314 0
20/06/2014
Approval date [1] 292314 0
10/11/2014
Ethics approval number [1] 292314 0
HE14/279

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

Contacts
Principal investigator
Name 54602 0
Prof Cathie Sherrington
Address 54602 0
The University of Sydney
Musculoskeletal Health Sydney, School of Public Health
Level 10 North, King George V Building
Royal Prince Alfred Hospital (C39)

PO Box M179
MISSENDEN ROAD NSW 2050 Australia
Country 54602 0
Australia
Phone 54602 0
+61 2 8627 6265
Fax 54602 0
Email 54602 0
[email protected]
Contact person for public queries
Name 54603 0
Amanda Bates
Address 54603 0
Health Promotion, Illawarra Shoalhaven Local Health District
Level 1, 67-71 King Street, Warrawong NSW 2502 Australia

Postal Address: Locked Bag 9, Wollongong NSW 2500 Australia
Country 54603 0
Australia
Phone 54603 0
+61 242216786
Fax 54603 0
+61 2 4221 6722
Email 54603 0
[email protected]
Contact person for scientific queries
Name 54604 0
Cathie Sherrington
Address 54604 0
The University of Sydney Musculoskeletal Health Sydney, School of Public Health Level 10 North, King George V Building Royal Prince Alfred Hospital (C39) PO Box M179 MISSENDEN ROAD NSW 2050 Australia
Country 54604 0
Australia
Phone 54604 0
+61286276265
Fax 54604 0
+61 2 8627 6262
Email 54604 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results.
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication.
Available to whom?
Data will be available on a case-by-case basis at the discretion of the Principal Chief Investigator.
Available for what types of analyses?
For meta-analysis.
How or where can data be obtained?
Access subject to approvals by Principal Chief Investigator ([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3371Study protocolBates A, Furber S, Tiedemann A, Ginn K, van den Dolder P, Howard K, Bauman A, Chittenden C, Franco L, Kershaw M, Sherrington C. Home-based exercise programs to prevent falls and upper limb dysfunction among community-dwelling older people: study protocol for the BEST (Balance Exercise Strength Training) at Home randomised controlled trial. Journal of Physiotherapy. 2018;64(2):121.https://www.sciencedirect.com/science/article/pii/S1836955317301212 
3373Statistical analysis plan  [email protected]
3374Informed consent form  [email protected]
3375Ethical approval  [email protected]



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseTrial Protocol: Home-based exercise programs to prevent falls and upper limb dysfunction among community-dwelling older people: study protocol for the BEST (Balance Exercise Strength Training) at Home randomised, controlled trial.2018https://dx.doi.org/10.1016/j.jphys.2017.10.001
N.B. These documents automatically identified may not have been verified by the study sponsor.