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Trial registered on ANZCTR
Registration number
ACTRN12613001314718
Ethics application status
Approved
Date submitted
22/11/2013
Date registered
25/11/2013
Date last updated
27/08/2014
Type of registration
Prospectively registered
Titles & IDs
Public title
Is running re-education group more effective than high level balance group in reducing falls in the elderly living in the community?
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Scientific title
Is running re-education group more effective than high level balance group in reducing falls in the elderly living in the community?
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Secondary ID [1]
283640
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Community dwelling individuals who are over the age of 65 and have a history of one or more falls in the last 12 months
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Condition category
Condition code
Injuries and Accidents
290972
290972
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0
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Other injuries and accidents
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Physical Medicine / Rehabilitation
290974
290974
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0
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Physiotherapy
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The two interventions involved in this study are the High Level Balance group and the Running Re-education group.
Running re-education focuses on dynamic balance with an emphasis on quick movement and reaction in response to a perturbation. It is not the intention of the group for patients to return to running. It is called “Running” since all the components of its exercises involve a biomechanical element of running.
The High Level Balance Group is designed to provide an environment to facilitate measurable improvement in dynamic balance and offer strength training through functional activities. The program contains both aerobic and strengthening exercises performed at moderate intensity. Progression will be made accordingly to the participant’s capability
Patients in either group participate in a 60 min session, twice a week for 6 weeks.
Both groups involve a series of rehabilitation exercises all supervised by a physiotherapist and an allied health assistant.
A record sheet will be utilized in each session to document a patient's completion of an exercise component.
Both interventions will receive educational components encompassing, nursing, podiatry, occupational therapy, dietetics, physiotherapy and pharmacy.
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Intervention code [1]
288337
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Rehabilitation
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Intervention code [2]
288338
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Prevention
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Comparator / control treatment
The standard treatment is the High Level Balance Group
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Control group
Active
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Outcomes
Primary outcome [1]
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The frequency of falls will be captured by the Falls Diary
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Assessment method [1]
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Timepoint [1]
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At baseline and at 26 weeks post intervention. Falls will be verified by a monthly phone call between within this period.
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Secondary outcome [1]
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Step Test
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Assessment method [1]
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Timepoint [1]
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Measured at baseline and at the completion of the 6 week program
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Secondary outcome [2]
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Dynamic balance will be assessed by the 4 square step test
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Assessment method [2]
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Timepoint [2]
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Measured at baseline and at the completion of the 6 week program
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Secondary outcome [3]
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Falls Efficacy Scale is used to determine how confidently clients feel they are able to undertake an activity on a scale of 0 (not confident at all) to 10 (completely confident)
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Assessment method [3]
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Timepoint [3]
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Captured at baseline, weeks 1, 6 and 26 post intervention
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Eligibility
Key inclusion criteria
Participants will be invited to participate provided they fulfill the following inclusion criteria:
Adult aged over 65 years referred to Community Rehabilitation Program at Peter James Centre with a history of one or more falls in the twelve months prior to being referred. A fall will be defined as “an unexpected event in which the participant comes to rest on the ground, floor, or lower level” (Lamb et al., 2005). This will be asked of the participants using the recommended wording: In the past twelve months, “have you had any fall including a slip or a trip in which you lost your balance and landed on the floor or ground or lower level in the?” (Lamb et al., 2005).
Able to understand Basic English. This criterion will be passed if potential participants are able to read and understand the information and consent form. This understanding will be demonstrated to recruiters through patients verbally explaining their understanding of the risks and benefits of their participation in the study.
Participants must be cognitively able to give informed consent and/or follow instructions. This will be guided by clinical judgment.
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Minimum age
65
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Participants will be excluded if they:
Live in supported accommodation (either low level or high level care).
Require assistance of another person for transferring or walking.
Are receiving individual physiotherapy while concurrently in a group program to enable any group differences to be assigned to the interventions with more confidence.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited on a consecutive basis from patients attending the Community Rehabilitation Program at Peter James Centre, Eastern Health. The treating physiotherapist will identify potential participants appropriate for the interventions with respect to the inclusion and exclusion criteria. The treating physiotherapist during a face-to-face session will provide verbal and written information about this study to the patient. Patients will be given the opportunity to discuss and clarify their concerns with both the principal researcher and associate researchers who will be available.
It must be noted that patients who participate in the study will be those who have just completed their one-on-one therapy with the physiotherapist. The treating physiotherapist will not have any influence on the patients' care or allocation. The clinicians who run the two groups will for obvious reasons be aware of the allocation. Therefore allocation is not concealed.
The secondary outcome measurements ("Time up and Go", "Four Square Step Test" and the "Falls Efficacy Scale") will be obtained by a third party who are not privy to the allocation.
Aim is to obtain 20 participants for each group (total 40)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A coin-tossing approach will be used to randomize the subjects.
The therapist distributing the information will not be a member of the research team. Participants will be advised that participation in the project is completely voluntary, and that their decision, whether to participate or not, will not affect their normal therapy.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
The sample size of this pilot trial is designed to be sufficient to estimate effect sizes in the intervention that could lead to a design of a fully powered randomised controlled trial. The sample size would be sufficient to detect very large differences between the two interventions if these existed at power of 0.80 and alpha level of 0.05. For example, it would be sufficient to detect a reduction in falls rate from 0.6 (which is typical of this population) to 0.2, and sufficient to detect very large effect sizes (standardised mean differences) of 0.90 between the two interventions.
The primary analysis will determine an estimate of the effect size on the difference in falls rate between the two interventions, and the secondary analysis will estimate the effect size for the secondary continuous outcomes. The number of participants who fall and the number of participants who do not fall will be compared with relative risk ratios. Negative binomial regression models will then be applied to compare the number of falls and the falls rate per person in the two interventions groups in the 6 months. For continuous secondary outcomes, analysis of covariance (ANCOVA) will be used to compare the 2 groups at 6 weeks and 26 weeks, using the baseline measure as a covariate.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
13/09/2014
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
40
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
1756
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Peter James Centre - Forest Hill
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Recruitment postcode(s) [1]
7579
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3151 - Burwood East
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Peter James Hospital
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Address [1]
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Cnr. Mahoneys Road & Burwood Highway
Burwood East
Vic 3151
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Country [1]
288320
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Australia
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Primary sponsor type
Hospital
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Name
Eastern Health
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Address
Cnr. Mahoneys Road & Burwood Highway
Burwood East
Vic 3151
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Country
Australia
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Secondary sponsor category [1]
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Hospital
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Name [1]
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Eastern Health
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Address [1]
287038
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Cnr. Mahoneys Road & Burwood Highway
Burwood East
Vic 3151
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Country [1]
287038
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Eastern Health
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Ethics committee address [1]
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Level 2, 5 Arnold St Box Hill Vic 3128
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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28/11/2013
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Approval date [1]
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28/07/2014
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Ethics approval number [1]
290216
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Summary
Brief summary
There is evidence that suggest exercise can reduce the risk of falls and its associated injuries for the older population living in the community. Clients who are at risk or have a history of falls may be referred to the High Level Balance Group in the community rehabilitation program at Eastern Health, where the exercises are designed to strengthen and build standing endurance to improve an individual’s balance. The other exercise class offered is the Running Re-education Group; patients participate in challenging tasks which demand balance and speed. This trial aims to find out whether running re-education group is more effective in reducing falls in the elderly living in the community.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mr John Tran
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Address
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Peter James Centre
Cnr. Mahoneys Road & Burwood Highway
Burwood East
Vic 3151
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Country
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Australia
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Phone
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+61 3 9881 1842
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Fax
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Email
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ulnardeviation@hotmail.com
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Contact person for public queries
Name
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Cynthia Fong
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Address
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Peter James Centre
Cnr. Mahoneys Road & Burwood Highway
Burwood East
Vic 3151
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Country
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Australia
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Phone
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+61 3 9881 1842
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Fax
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Email
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cynthia.fong@easternhealth.org.au
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Contact person for scientific queries
Name
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John Tran
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Address
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Peter James Centre
Cnr. Mahoneys Road & Burwood Highway
Burwood East
Vic 3151
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Country
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Australia
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Phone
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+61 3 9881 1842
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Fax
44496
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Email
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ulnardeviation@hotmail.com
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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
No additional documents have been identified.
Download to PDF