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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
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
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
s.fu@uq.edu.au
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
s.fu@uq.edu.au

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.