Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000482369
Ethics application status
Approved
Date submitted
3/09/2008
Date registered
29/09/2008
Date last updated
29/09/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Wii Fit: the new generation tool for improving balance, health and well-being for women?
Scientific title
Investigations of the effect a novel treatment intervention on balance: Wii Fit trade mark for women
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Ageing 3640 0
Balance 3641 0
sedentary lifestyle 3642 0
Condition category
Condition code
Physical Medicine / Rehabilitation 3806 3806 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each participant will undertake training two times per week for a period of 30 minutes over 10 weeks. Women in the Wii Fit trademark group will follow the training program prescribed by the assessing physiotherapist using aspects from the manufacturers recommended balance, yoga, strength and aerobic programs that are suitable for age and physical ability of each individual participant.
Intervention code [1] 3354 0
Lifestyle
Intervention code [2] 3355 0
Prevention
Intervention code [3] 3356 0
Rehabilitation
Comparator / control treatment
Women in the Balance Strategy Training Exercise Program group will undertake training under the guidance of a physiotherapist suitable to their physical ability. 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.
Women in the fitness training group will exercise under the supervision of a physiotherapist and will include treadmill walking/jogging, cycle ergometer and rowing.
Each participant will undertake training two times per week for a period of 30 minutes over 10 weeks.
Control group
Active

Outcomes
Primary outcome [1] 4703 0
balance and mobility measure
Measurements of balance will include; functional reach [Duncan et al 1990], Step test [Hill et al 1996], Timed up & go(TUG) [Podsiadlo & Richardson 1991], TUGmanual & TUGcognitive [Lundin-Ohlssen et al 2001] and mCTSIB, unilateral stance, and reaction time using the Balance Master.
Timepoint [1] 4703 0
baseline and 10 weeks follow-up
Primary outcome [2] 4704 0
Muscle Strength: Strength of quadriceps, hip abductors and adductors will be measured using a spring gauge
Timepoint [2] 4704 0
baseline and 10 weeks follow-up
Primary outcome [3] 4705 0
Cardiovascular fitness: Fitness will be measured using a 6 minute walk test
Timepoint [3] 4705 0
baseline and 10 weeks follow-up
Secondary outcome [1] 7938 0
ankle flexibility:Ankle joint flexibility using a gravity goniometer
Timepoint [1] 7938 0
baseline and 10 weeks follow-up
Secondary outcome [2] 7939 0
Sensory input will be measured for touch on the sole of the feet using von Frey hairs, proprioception at the knee by joint repositioning [Lord et al 2002; Low Choy et al 2007].
Vestibular function by the dynamic visual acuity test (DVA)
Timepoint [2] 7939 0
baseline and 10 weeks follow-up
Secondary outcome [3] 7940 0
Well being will be measured using a Likert 5 point scale for self-rating of health
Timepoint [3] 7940 0
baseline and 10 weeks follow-up

Eligibility
Key inclusion criteria
Subjects will be aged between 20 and 70 years and willing to participate in a pre and post –intervention assessment as well as a two times weekly 30 minute exercise sessions for 10 weeks
Minimum age
20 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Subjects will be excluded if they have a neuromusculoskeletal condition that precludes moderate to intense exercise eg cardiomyopathy, acute illness. Subjects will also be excluded if unable or unwilling to give informed consent or commit to the intervention requirements

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2008
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] 1131 0
4072

Funding & Sponsors
Funding source category [1] 3819 0
Self funded/Unfunded
Name [1] 3819 0
Country [1] 3819 0
Primary sponsor type
Individual
Name
Jenny Nitz
Address
Division of Physiotherapy
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia
QLD 4072
Country
Australia
Secondary sponsor category [1] 3432 0
University
Name [1] 3432 0
The University of Queensland
Address [1] 3432 0
Division of Physiotherapy School of health and Rehabilitation SciencesThe Univeristy of Queensland St Lucia QLD 4072
Country [1] 3432 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5878 0
University of Queensland
Ethics committee address [1] 5878 0
Medical Research Ethics Committee
The University of Queensland
St Lucia
QLD 4072
Ethics committee country [1] 5878 0
Australia
Date submitted for ethics approval [1] 5878 0
Approval date [1] 5878 0
30/07/2008
Ethics approval number [1] 5878 0
2008001264

Summary
Brief summary
By the year 2031 women (and men) who are currently 40 years of age and over will comprise the 25% of the Australian population aged over 65. The projected fall related health costs will have escalated to over $1000 million annually (Moller 2003) and the current rate of falls (1 in 3 older persons falling annually) will continue for those over 65 (Morris et al 2004) unless new initiatives are implemented. Moller (2003) identified a need for more effective prevention of falls and we believe this intervention must start before decline in balance and bone density become established. Current initiatives that aim to reduce falls and fall related injury and are available in the community presently target adults 65 years and over.

Over the last eight years our research team has undertaken a number of projects that helped to inform the evidence base regarding the decline in the sensory-motor contribution to balance and the efficacy of specific balance strategy training in counteracting this decline. Our research team has demonstrated that postural stability and functional balance capacity are significantly reduced in women across the menopause transition period (40 to 60 years) and further reduced in the older person (Isles et al 2004, Low Choy et al 2003, Nitz et al 2003). We have found reduced strength and flexibility, reduced sensory acuity, and increased joint position error and higher thresholds of vibration sensitivity negatively contributing to this early change period in balance ability (Low Choy et al 2008; Low Choy et al 2007; Nitz & Low Choy 2004). Similar findings were reported by Lord & Ward (1994) although there was less data for women under 65 with only 20 to 30 subjects in the 40s and 50s decade groups compared to 118 and 116 for our study. A contributing factor associated with reduced strength and flexibility and reduced ability to balance in women, (Nitz & Low Choy 2007) is a lower self-reported activity level where habitual patterns of activity range from sedentary through to walking several times a week at a comfortable pace.
Another most important aspect revealed by our studies of women aged 40 to 80 years has been the identification of the prevalence of falls across these decades and the major physiological factors that might have contributed to the falls in these women. Of particular interest are the findings over the 5 year longitudinal assessment study of balance and postural stability in women aged 40-80. Falls were recorded in 8.5% of women in their 40s in the year 1 audit and this rose to 15% in year 5. For those in their 50s, 13.5% had fallen at year 1 audit. This prevalence remained stable over 5 years. 24.5% of women in their 60s had fallen at year 1 audit but this prevalence dropped slightly to 21% by year 5 and 43% in their 70s had fallen at year 1 audit and this prevalence dropped to 31% by year 5. Of interest is the rise in multiple fall episodes in some women in their 40s through to 70s in the 5 year data collection period (Nitz et al, in review). This provides compelling evidence for the need to target women prior to age 64 for pre-emptive balance preserving intervention. Of particular interest for these younger women is what type of exercise might be adopted to address these declines and potential to fall.
We propose to investigate three different exercise approaches that theoretically might reduce or delay the decline in balance and sensorimotor function in younger women. The effect of three approaches to slowing the balance, sensorimotor and fitness decline problem through three different exercise programs will be compared. Previously, balance strategy training has been shown and to improve balance (Hourigan et al 2008) as has aerobic exercises (Lui-Ambrose et al 2007). The effect achieve through exercise using a Wii.Fit™ will be evaluated. Then the three exercise approaches will be compared for effect.

Primary aims are to:
1. demonstrate the effect of a training program using the Wii.Fit trademarkon balance, sensorimotor function and fitness in women aged 20-70years.
2. compare the effect in women aged 20-70year of Wii.Fit trademark training with balance strategy training (BST) and aerobic training (AT).
Secondary aims are to identify whether one training method is better than another in this cohort of women
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28898 0
Address 28898 0
Country 28898 0
Phone 28898 0
Fax 28898 0
Email 28898 0
Contact person for public queries
Name 12055 0
Stephanie Fu
Address 12055 0
Division of Physiotherapy
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia
QLD 4072
Country 12055 0
Australia
Phone 12055 0
+61 7 3365 2779
Fax 12055 0
Email 12055 0
[email protected]
Contact person for scientific queries
Name 2983 0
Stephanie Fu
Address 2983 0
Division of Physiotherapy
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia
QLD 4072
Country 2983 0
Australia
Phone 2983 0
+61 7 3365 2779
Fax 2983 0
Email 2983 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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