Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000396224
Ethics application status
Not yet submitted
Date submitted
29/04/2009
Date registered
2/06/2009
Date last updated
6/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of low friction-based exercise and balance-strategy training in the treatment of balance problems in the elderly: a pilot study
Scientific title
Comparison of low friction-based exercise and balance-strategy training in the treatment of balance problems in the elderly: a pilot study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Balance impairments in the elderly 4693 0
Condition category
Condition code
Physical Medicine / Rehabilitation 237143 237143 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Low friction based exercise in combination with a home exercise programme: use of BedEx exercise mats which consist of mats which have 2 levels of friction on either side of the mats. Using the mats on the high friction sides creates a high level of stability and using the mats with the low friction sides together gives a lower level of stability. Exercises will be commenced in sitting and progressed to standing, reaching, stepping and walking exercises as the participants become familiar with the exercises and as their level of skill allows.
The home exercise programme will consist of sitting, standing, stepping, reaching and walking activities. Participants will be asked to complete it 3 times per week. This will be completed concurrently with the 8 week trial.
Intervention code [1] 4454 0
Rehabilitation
Comparator / control treatment
Balance strategy training in combination with a home exercise programme. Particpants in this group will undertake balance exercises in the form of balance-strategy training. This consists of balance tasks in a variety of positions (sitting, standing, reaching, stepping, walking) using equipment such as chairs, steps, foam and balance discs.
The home exercise programme will be the same as the intervention group and will also run concurrently with the 8 week training programme.
Control group
Active

Outcomes
Primary outcome [1] 5847 0
The primary aim of this study is to determine whether an exercise programme based on low friction principles is more effective at reducing the number of falls in an elderly population compared with an exercise programme based on balance-specific strategy training. This will be measured by the completion of a falls diary on which the participants record whether they have had any falls, trips, slips or near misses on any given day during the trial. The diary will be supplied to the participants with defintions given for the adverse events. This will be compared with the number of falls, slips, trips and near misses experienced by the participants in the eight weeks prior to the trial.
Timepoint [1] 5847 0
Once weekly for 8 weeks prior to and during the 8 week trial
Secondary outcome [1] 241865 0
Does training based on low friction principles reduce the fear of falling in an elderly population more effectively than balance-specific strategy training? This is measured using the Modified Falls Efficacy Scale. This scale will be administered to the participants at the start and end of the trial
Timepoint [1] 241865 0
Begining and end of trial
Secondary outcome [2] 241866 0
Does training based on low friction principles improve balance in an elderly population more effectively than balance-specific strategy training? This will be measured by the use of the following balance tests: static standing tests, the Step Test, Lateral and Functional Reach Tests and the Timed Up and Go Test.
Timepoint [2] 241866 0
At the begining and end of the trial.
Secondary outcome [3] 241867 0
Is an exercise programme based on low friction principles safe for elderly participants? This will be measured by the trial physiotherapists keeping a record of any adverse effects (musculoskeletal, medical) experienced during exercise sessions.
Timepoint [3] 241867 0
Weekly during the trial, ending at the 8 week point

Eligibility
Key inclusion criteria
Aged 65 years or over;
Have had at least one fall in the previous year;
Live independently in the community (own home, retirement village, low-care hostel);
Can mobilise independently with or without a walking aid (stick or walking frame);
Speak and understand written and spoken English
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Under age 65;
Nil falls in previous years;
Live in nursing home;
Wheelchair dependent or require another person's assistance to walk;
Unable to understand written or spoken English;
Live too far from the centre to guarantee regular attendance;
Have the following medical conditions: dementia, unstable angina/chest pain, uncontrolled blood pressure (high or low), severe pain, diabetes with hypo or hyperglycaemic episdodes, neurological disorder - Parkinson’s disease, stroke, neuropathy or uncontrolled epilepsy, significant visual impairment

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/06/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
4
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4871 0
Other
Name [1] 4871 0
Home and Community Care, West Moreton South Burnett Health Service District
Country [1] 4871 0
Australia
Primary sponsor type
Individual
Name
Claire Connolly
Address
Home and Community Care,
Ipswich Health Plaza,
21 Bell St,
Ipswich,
QLD 4305
Country
Australia
Secondary sponsor category [1] 4405 0
None
Name [1] 4405 0
Address [1] 4405 0
Country [1] 4405 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 6934 0
Flinders Clinical Research Ethics Committee
Ethics committee address [1] 6934 0
Flinders Medical Centre,
Bedford Park,
SA 5042
Ethics committee country [1] 6934 0
Australia
Date submitted for ethics approval [1] 6934 0
16/04/2009
Approval date [1] 6934 0
Ethics approval number [1] 6934 0
EC00188
Ethics committee name [2] 7071 0
West Moreton Health Service District Human Resource Ethics Committee
Ethics committee address [2] 7071 0
Dawson House,
The Park-Centre for Mental Treatment, Research and Education,
Richlands,
QLD 4077
Ethics committee country [2] 7071 0
Australia
Date submitted for ethics approval [2] 7071 0
19/05/2009
Approval date [2] 7071 0
Ethics approval number [2] 7071 0
EC00184

Summary
Brief summary
Falls are a significant cause of injury and death in the population aged over 65 years. Following
a fall, people often report they have become fearful that they will fall again and restrict their
activities in order to try to reduce their perceived risk. As a result, a previously active person
may become housebound or restrict outdoor activities to essential chores, such as General Practitioner visits.
Such behaviour does not necessarily reduce the risk of another serious fall and can lead to the
person becoming depressed, frailer and having a much higher likelihood of being admitted to
residential care.
Recent research has shown that exercise is an effective way to reduce participants’ risk of falls
and also to keep people on their feet and doing the activities which they enjoy. There is
uncertainty about the exact nature that the exercise component should take. Many
programmes use a combination of balance and strength-based exercises to train for better
balance. However new research has suggested that training on variable surfaces may be a
better way to develop balance skills and reduce the risk of falls.
To test this idea, this study will assign participants to two different exercise groups. Participants
will attend weekly one hour sessions of the exercise group to which they have been randomly
assigned for eight weeks. Measurements of balance, level of falls risk, fear of falling and actual
number of falls experienced will be taken prior to commencing the programme and at the end
of the eight week course. Researchers will then be able to examine whether the novel exercise
regimen is more effective than the traditional form of exercises for reducing falls and fear of
falls, and improving balance capacity. Treatment of falls-related injuries such as a broken hip is
costly not only to the health service but also to the affected person, so any preventative
strategy that enables at-risk individuals to develop higher levels of balance within an eight
week period will be welcomed by clients, clinicians and service providers alike.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29546 0
Address 29546 0
Country 29546 0
Phone 29546 0
Fax 29546 0
Email 29546 0
Contact person for public queries
Name 12793 0
Claire Connolly
Address 12793 0
Ipswich Health Plaza,
PO Box 878,
Ipswich,
QLD 4305
Country 12793 0
Australia
Phone 12793 0
+61 7 38172376
Fax 12793 0
+61 7 38172439
Email 12793 0
[email protected]
Contact person for scientific queries
Name 3721 0
Claire Connolly
Address 3721 0
Ipswich Health Plaza,
PO Box 878,
Ipswich,
QLD 4305
Country 3721 0
Australia
Phone 3721 0
+61 7 38172376
Fax 3721 0
+61 7 38172439
Email 3721 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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