Trial Review

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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?
Scientific title
Is running re-education group more effective than high level balance group in reducing falls in the elderly living in the community?
Secondary ID [1] 283640 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

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 290582 0
Condition category
Condition code
Injuries and Accidents 290972 290972 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 290974 290974 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 288337 0
Rehabilitation
Intervention code [2] 288338 0
Prevention
Comparator / control treatment
The standard treatment is the High Level Balance Group
Control group
Active

Outcomes
Primary outcome [1] 290951 0
The frequency of falls will be captured by the Falls Diary
Timepoint [1] 290951 0
At baseline and at 26 weeks post intervention. Falls will be verified by a monthly phone call between within this period.
Secondary outcome [1] 305669 0
Step Test
Timepoint [1] 305669 0
Measured at baseline and at the completion of the 6 week program
Secondary outcome [2] 305670 0
Dynamic balance will be assessed by the 4 square step test
Timepoint [2] 305670 0
Measured at baseline and at the completion of the 6 week program
Secondary outcome [3] 305671 0
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)
Timepoint [3] 305671 0
Captured at baseline, weeks 1, 6 and 26 post intervention

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.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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)
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.
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
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/09/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1756 0
Peter James Centre - Forest Hill
Recruitment postcode(s) [1] 7579 0
3151 - Burwood East

Funding & Sponsors
Funding source category [1] 288320 0
Hospital
Name [1] 288320 0
Peter James Hospital
Country [1] 288320 0
Australia
Primary sponsor type
Hospital
Name
Eastern Health
Address
Cnr. Mahoneys Road & Burwood Highway
Burwood East
Vic 3151
Country
Australia
Secondary sponsor category [1] 287038 0
Hospital
Name [1] 287038 0
Eastern Health
Address [1] 287038 0
Cnr. Mahoneys Road & Burwood Highway
Burwood East
Vic 3151
Country [1] 287038 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290216 0
Eastern Health
Ethics committee address [1] 290216 0
Ethics committee country [1] 290216 0
Australia
Date submitted for ethics approval [1] 290216 0
28/11/2013
Approval date [1] 290216 0
28/07/2014
Ethics approval number [1] 290216 0

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

Contacts
Principal investigator
Name 44494 0
Mr John Tran
Address 44494 0
Peter James Centre

Cnr. Mahoneys Road & Burwood Highway
Burwood East
Vic 3151
Country 44494 0
Australia
Phone 44494 0
+61 3 9881 1842
Fax 44494 0
Email 44494 0
[email protected]
Contact person for public queries
Name 44495 0
Cynthia Fong
Address 44495 0
Peter James Centre

Cnr. Mahoneys Road & Burwood Highway
Burwood East
Vic 3151
Country 44495 0
Australia
Phone 44495 0
+61 3 9881 1842
Fax 44495 0
Email 44495 0
[email protected]
Contact person for scientific queries
Name 44496 0
John Tran
Address 44496 0
Peter James Centre

Cnr. Mahoneys Road & Burwood Highway
Burwood East
Vic 3151
Country 44496 0
Australia
Phone 44496 0
+61 3 9881 1842
Fax 44496 0
Email 44496 0
[email protected]

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

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