Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000625471
Ethics application status
Approved
Date submitted
4/12/2007
Date registered
6/12/2007
Date last updated
6/12/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of a specific balance-strategy training program in women aged 40-60 years
Scientific title
An Randomised Controlled Trial to identify the effect of a specific balance strategy training program for improving balance, postural stability, mobility, health and wellbeing in asymptomatic women aged 40-60 years.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fall prevention
Healthy Ageing
Lifestyle change
Balance 2602 0
Condition category
Condition code
Physical Medicine / Rehabilitation 2717 2717 0 0
Physiotherapy
Public Health 2718 2718 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Specific Balance Strategy Exercise Program. Subjects in the intervention group will attend a one hour twice-weekly specific balance-strategy training program for 12 weeks. The program will be delivered using work-stations that target the multiple elements of balance that are integral to efficient balance and mobility. Content of this program will include functional strength training and flexibility exercises that load trunk and lower limb muscles in all planes of movement, exercises for postural control and tasks that challenge medio-lateral stability and work participants at the limits of their stability; tasks that foster the use of ankle, hip, stepping and suspension strategies along with speed and efficient reaction times will be used. The program and tasks will be progressed by adding surface and visual challenges and by adding dual / multiple tasks.
Intervention code [1] 2337 0
Prevention
Intervention code [2] 2338 0
Rehabilitation
Intervention code [3] 2339 0
Lifestyle
Comparator / control treatment
Normal home-based chores and or walking no more than twice a week, self paced, not receiving any program.
Control group
Active

Outcomes
Primary outcome [1] 3611 0
Clinical and laboratory balance measures
Clinical measures include functional reach (Duncan et al, 1990) measures reaching forward to the limits of stability from a bilateral stance position;lateral reach with right and left hands (Brauer et al 1999) measures reaching sideways to the limits of stability from a bilateral stance position;the functional step test with right and left foot (Hill et al 1996) measures speed of performing a dynamic standing task with the number of repeated steps on and of a block 7.5 cm in height, in 15 seconds recorded; timed up and go (TUG) test (Shumway-Cook et al, 2000) measures the time taken to stand up from a chair, walk three metres as quickly and safely as possible past a line on the floor, turn around, walk back to the chair and sit down with the back against the chair; time up and go cognitive test (Shumway-Cook et al 2000) measures the time taken to complete the TUG test while the subject counts backward by three from a randomly selected number between 20 and 100;rapid stepping test (Mendall & Alexander, 2000) measures the time taken to make 24 random steps as fast as possible under the tester's command; timed tandem walk measures the time taken to complete 10 tandem steps forward, backwards and then with eyes open and closed (Fregley et al, 1968)


Laboratory measures of postural stability will be measured by recording velocity of sway using the Balance Master force-plate system (Neurocom, Balance Master 6.0) while the protocol for the modified Clinical Test for the Sensory Integration of Balance (mCTSIB) (Shumway-Cook and Horak, 1986) and Single Limb Stance (Bohannon et al, 1984) are carried out.

Modified Clinical test for sensory integration of balance (mCTSIB) involves standing on a firm surface (eyes open, eyes closed) and then on a foam surface (eyes open, eyes closed). The test has established validity (Alhanti et al, 1997; Di Fabio et al, 1990; Cohen, 1993; Newton, 1995; Teasdale et al 1991), retest and inter-tester reliability (Liston et al, 1996) and is a valid measure of changes in postural stability across the 40 to 60 age period (Low Choy et al, 2003). The test manipulates the senses and determines reliance on vision under conditions of proprioceptive conflict. When the propriocetpive system is challenged by standing on a high-density foam pad with eyes closed, the vestibular system assists to resolve this conflict and maintain postural stability. When the vestibular system is inefficient, increased postural sway and/or a fall may result.

Single limb stance test (Bohannon et al, 1984, Newton 1989) with right foot with eyes open (EO) and eyes closed (EC);left foot with EO and EC
This test challenges balance with the narrower base of support condition and with the removal of vision, reveals those subject reliant on vision for balance. This test is important to include as the single limb stance test has been shown to be an important predictor of injurious (serious) falls in older people (Vellas et al, 1997).
Timepoint [1] 3611 0
At baseline, 3 months, 9 months and 24 months after intervention commencement
Primary outcome [2] 3612 0
Measures of somatosensory function:- Tactile acuity: Monofilaments of set sizes (1-7) will be applied to the ankle, heel and big toe to determine threshold sensation. The size of the monofilament at threshold sensation will be recorded.
- Vibration sense: An electronic vibration sense unit, vibrating at 200 Hz will be applied to tibial tuberosity to determine threshold vibration perception. The vibration amplitude at threshold perception will be recorded.
- Joint position sense: The difference in big toe position (degrees) will be determined by asking subjects to match the big toe position either side of a large, Perspex protractor.
Timepoint [2] 3612 0
At baseline, 3 months, 9 months and 24 months after intervention commencement
Primary outcome [3] 3613 0
Measures of muscle: strength and length
Tests of strength will be measured using a spring gauge which will be applied at 90 degrees to the quadriceps and hip external rotators in sitting and the hip adductor and abductor muscles in supine lying.

- Measure of Ankle Flexibility (weight-bearing dorsiflexion)
Test of ankle flexibility will be measured using the knee-to-wall principle with a tape measure. The participant stand in front of a wall with the test foot's second toe and midline of the hell and knee maintained in a plane perpendicular to the wall. The participant slowly lunged forward into talocrural dorsiflexion until the knee contacted the wall and progressively move the foot back to the point where the knee could just touch the wall with the hell sustained on the ground.
Timepoint [3] 3613 0
At baseline, 3 months, 9 months and 24 months after intervention commencement
Secondary outcome [1] 6052 0
Cardiovascular endurance: 6 minutes walk
Timepoint [1] 6052 0
At baseline, 3 months, 9 months and 24 months after intervention commencement
Secondary outcome [2] 6053 0
Habitual activity level will be rated using a self report method which offers categories for exercise across a six point scale according the frequency and intensity of activity regularly undertaken (Hirvensalo et al, 2000). This scale will be used to allocate volunteers to groups for comparison.
Timepoint [2] 6053 0
At baseline, 3 months, 9 months and 24 months after intervention commencement
Secondary outcome [3] 6054 0
Self-perceived health status (Short Form-36)
Timepoint [3] 6054 0
At baseline, 3 months, 9 months and 24 months after intervention commencement

Eligibility
Key inclusion criteria
- live independently in the community
- aged between 40 and 60 years of age
- have no history of unexplained falls/recent injury such as sprained ankle within last 12 months
- ambulate without an aid
- able to give informed consent
- able to undertake comprehensive assessment
- willing to commit to at least a 12 week program and 24 months follow-up period
-classify their habitual physical activity as home based chores or self paced activity once or twice a week
Minimum age
40 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- have fallen at some time within the previous year
- have an unstable cardiac condition
- live in a region too far from the three sites where the program is to be delivered and thus could not guarantee regular attendance
- have uncorrected vision
- have diagnosed pathology that could account for changes in postural stability including neurological disorders,dizziness or vestibular pathology,insulin-dependent diabetes,peripheral neuropathy,peripheral vascular disease that requires active management or surgical intervention;major musculoskeletal dysfunction that requires active management or surgical intervention, and require medication for psychiatric disorders, depression or anxiety as an association of such medication with falls has been demonstrated

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



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/10/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 511 0
4072

Funding & Sponsors
Funding source category [1] 2855 0
Other
Name [1] 2855 0
Dorothy Hopkins award for Clinical Trial Queensland Branch Australian Physiotherapy Association
Country [1] 2855 0
Australia
Primary sponsor type
University
Name
Division of Physiotherapy School of Health and Rehabilitation Sciences The University of Queensland
Address
Division of Physiotherapy
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia Campus
Brisbane QLD 4072
Country
Australia
Secondary sponsor category [1] 2573 0
None
Name [1] 2573 0
Address [1] 2573 0
Country [1] 2573 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
This study will determine whether a specific balance strategy training program is an effective form of exercise for healthy, but less active women aged between 40 to 60 years that can control the rate of decline in balance and sensori-motor function across the menopause transition. Whether participation leads to adoption of more active lifestyle will also be observed. A similar though not quite as challenging evidence based program that targeted the multiple elements of balance has been shown to be effective in older adults. This study will determine if undertaken during the pre-clinical period of balance decline it helps to prevent/reverse the detrimental balance decline that occurs in women during the menopause transition. Should the participants sustain the level of activity post- intervention a safer, healthier lifestyle is likely to ensue evidenced by enhanced self-perceived health status, reduction in fall rate and increased cardiovascular fitness. The study will also look at factors associated with compliance and motivation with uptake of exercise to develop more effective strategies for implementation of programs that are attractive and beneficial for this age group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28226 0
Address 28226 0
Country 28226 0
Phone 28226 0
Fax 28226 0
Email 28226 0
Contact person for public queries
Name 11383 0
Stephanie Fu
Address 11383 0
Division of Physiotherapy
School of Health and Rehabilitation Sciences
The University of Queensland
Brisbane QLD 4072
Country 11383 0
Australia
Phone 11383 0
+ 61 7 33652779
Fax 11383 0
+ 61 7 33651622
Email 11383 0
[email protected]
Contact person for scientific queries
Name 2311 0
Stephanie Fu
Address 2311 0
Division of Physiotherapy
School of Health and Rehabilitation Sciences
The University of Queensland
Brisbane QLD 4072
Country 2311 0
Australia
Phone 2311 0
+ 61 7 33652779
Fax 2311 0
+ 61 7 33651622
Email 2311 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

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

Documents added automatically
No additional documents have been identified.