The Effect of Progressive Balance Exercise on Postural Sway - a 4 Week Randomized Controlled Trial
Phase: NA
Conditions: Balance; Distorted, Fall
Sponsor: Region Västerbotten

The effect of progressive balance 
exercise on postural sway – a 4 
week randomized controlled trial
Today most fracture prevention measures targets the bone and osteoporosis. However, only 
about 20% of individuals with fractures have osteoporosis and at least 90% of all fractures 
are caused by a fall. Therefore, the present project builds on previous findings from our 
group identifying postural sway as an important risk factor for falls and aims to intervene 
against this risk factor in a randomized controlled trial targeting subjects at the highest risk 
for falls. 
Specific aims:
1.
Examine whether four weeks progressive balance training can improve 
parameters of body sway in measurements of static standing balance
2.
Investigate whether participants experience greater security to their own ability 
and less fear of future falls after 4 weeks of progressive balance training
3.
Investigate how long a potential effect of progressive balance training may be 
noticeable on participants’ experiences of greater security in their own ability and less fear of 
future falls
4.
3. Examine whether participation in balance training leads to reduced number of 
falls at follow-up after 6, 12 and 24 months
Background
Falls and fall-related injuries are major health concerns for elderly individuals; they cause 
functional decline and increased mortality, as well as incurring vast health care costs for 
society.1-3 Occurrences and consequences of falls are expected to increase globally with the 
growing number of elderly individuals. Hence, the improved detection and prediction of 
potential fall risk markers are of individual and societal importance. 

Falling can be the end result of intrinsic and extrinsic factors negatively affecting an 
individual’s ability to maintain balance,4 which are often revealed during sequences of body 
movement.5 Balance can be both dynamically and statically measured, the latter involves 
having the individual in a stationary standing position, from which results researchers have 
proposed impaired postural stability as a risk factor for falling.6,7 However, evidence 
regarding the association of postural instability with prospective falls is limited, and 
population-based cohort studies in this field are scarce.8 Other shortcomings of previous 
studies include the use of retrospective study designs,9 which increase the risks of recall bias 
and the identification of risk factors as the result of falls.10,11
Postural instability is preferably investigated using objective measures of posturography, the 
advantages of which over regular clinical assessments include the reduction of test 
performance variability and avoidance of subjective scoring systems.12 Recently, researchers 
have analyzed the performance of the Wii Balance Board (WBB; Nintendo, Kyoto, Japan) in 
the measurement of postural instability; WBB-based assessment has shown excellent 
concurrent validity and the ability to complement existing fall assessments.13,14
As of 2012, all 70-year olds in the Umeå municipality are invited to participate in the Healthy 
Ageing Initiative (HAI) study, which has currently enrolled more than 3000 participants. 
Among other measurements, we include assessment of postural stability using a Wii Balance 
Board (WBB; Nintendo, Kyoto, Japan) device. With each participant in a quiet stance, 
balance trials consisting of 60-second eyes-open (EO) and eyes-closed (EC) trials are 
performed. Participants are instructed to maintain an upright position throughout the test, 
stand relaxed, and avoid any arm or head movement. The WBB measures total COP sway 
length, representing the sum of postural sway in the anteroposterior and mediolateral 
directions.
Preliminary results from our analysis of data consisting of 1900 70-year-old individuals 
revealed that participants with postural sway in the 5th quintile had almost twice the risk of 

falling compared to the reference group, when the 1-year follow-up of prospective falls was 
performed. 
Thus the aim of the present follow-up study is to investigate if we can reduce the increased 
postural sway of participants who have been identified as having abnormal balance values, 
based on previous measurements. 
Project description
Study design
The present project is planned to be conducted as a 4-week randomized intervention study 
with a follow up time of 2 years.
Study population
Recruitment of individuals at high risk of falls from the Healthy Ageing 
Initiative
The Healthy Ageing Initiative (HAI) is an ongoing population based project aiming to reduce 
risk factors for non-communicable diseases (NCD) by risk factor evaluation and increased 
physical activity.15 In short, HAI is inviting all 70 year olds in Umeå municipality to a health 
examination where traditional and potential novel risk factors for diabetes, CVD and fractures 
are investigated. These include objective measures of physical activity, blood pressure, blood-
glucose, objective measured abdominal fat mass and ectopic fat, bone density and other 
features of bone quality, cognitive function, balance, walking ability, and different life style 
factors. At the second visit, all participants are informed about the results of tests performed 
and gets advice with a focus on physical activity, aiming at decreasing the risk of future 
diabetes, CVD and fractures. The counseling with focus on physical activity is based on 
motivational interviewing (MI) which is a directive patient-cantered counseling style to help 
the participants to explore and resolve their ambivalence about behavior change. They are 

contacted at 6 months and 12 months per telephone for follow up and are contacted for an in-
clinic follow up after 5 years. 
Participants in HAI identified as being in the highest quartile of measures of postural sway, 
indicating poor balance and high fall risk, are invited to participate by telephone contact, and 
will upon agreement be randomized into either the intervention group or control group. 
Participants will after the initial contact also receive written information about the study. We 
aim to recruit 90 individuals from the existing HAI study cohort

Study protocol
Please see figure 1 for figure of study protocol. 
Intervention protocol
Group 1
Twenty participants are randomised into the 
intervention 
group. The intervention group will perform 
three supervised 
group training sessions a week, consisting of 30 
minutes of balance 
training for 4 weeks.
Group 2
Forty participants are randomised into the control group and receive a health consultation that 
highlights the importance of physical activity and balance exercise according to standard 
practice within the HAI project. They are asked to return after 4 weeks for follow up.
Follow up
After 4 weeks, the groups are followed up with the same measures that are used in the 
Healthy Ageing Initiative that contains objective and functional balance tests, tests of muscle 
strength and a validated questionnaires on fear-of-falling and physical activity. Both groups 
will be offered the specific program for balance training post measurements, with instructions 
that it can be performed in the home setting according to the same principles offered to the 
intervention group. The groups are followed up after 6 and 12 months through 70-years-health 
checks on prospective falls and levels of physical activity.
Methods used for baseline and follow up
Measurements of postural stability
Postural stability is assessed using a Wii Balance Board (WBB) device (Nintendo, Kyoto, 
Japan) labeled “Nintendo RVL-WBC-01”, with a nominal sampling frequency of 100 Hz. The 
equipment is linked to a PC via Bluetooth connection “E1310E(00**)”, using drivers labeled 

“Manage Library for Nintendo’s Wiimote v1.7.00 by Brian Peek”. The software was designed 
in Microsoft C# by Prof. Göran Westling, Umeå University. The equipment’s power supply 
has been exchanged from battery to USB power. The validity and reliability of the WBB has 
been evaluated elsewhere, showing excellent conformation to other laboratory balance 
equipment, with mean differences in center of pressure (COP) variance ranging between 0.3 
to 3%.13 
Participants are examined during quiet stance involving trials of eyes open (EO) and eyes 
closed (EC) for 60 seconds each. Participants are instructed to maintain an upright position 
throughout the test and stand relaxed, while avoiding any arm or head movements. The WBB 
measures total COP sway length, representing the sum of postural sway in anteroposterior and 
Measurements of physical activity and capacity
Participants will be asked to complete the short form of the International Physical Activity 
Questionnaire (IPAQ),17 an instrument designed to estimate activity levels among adult 
populations in domains including: 1) leisure time PA, 2) domestic and gardening activities, 3) 
work- related PA and 4) transport-related PA. Individuals are asked to recollect the duration 
of activities (walking, moderate- and vigorous- intensity PA) during the last 7 days in each 
domain. Questionnaire responses are used to calculate MET-min data in accordance with 
IPAQ guidelines.17 
Participants will also be asked to perform the Time-Up-and-Go (TUG) test,18 commonly used 
by clinicians to assess lower leg muscle strength, gait performance and overall functional 
mobility in elderly individuals. Testing involves participants rising unaided from an armchair 
and walking forward 3 meters until they reach a selected line on the floor, at which point they 
turn and come back to a seated position. Research nurses provides instructions and measures 
total testing time using a stopwatch. The TUG test have previously demonstrated good inter-

rater reliability (ICC=0.99).18 Testing of isometric muscle strength involves using a hydraulic 
hand dynamometer (Jamar, Patterson Medical, Warrenville, IL, USA) to measure 
participant’s maximum grip strength in the non-dominant hand. Participants will be instructed 
to keep the arm angled at 90° and maintain the elbow in proximity to the waist during the test. 
The maximum value out of 2 consecutive attempts is subsequently recorded. 
Measurement of Confidence in Balance Ability and Fear-of-Falling
Participants will also be asked to report confidence in balance ability and fear of falling. This 
will be accomplished through two questionnaires. The Falls Efficacy Scale International 
(FES-I) measures fear of falling and is comprised of 16 questions on a scale from 1-4.19 The 
Original Falls Efficacy Scale (FES) is also included and measures confidence in balance 
ability, formed by answering 13 questions on a scale from 1-10.20 
Anthropometric measures
Anthropometric data will be obtained using a scale (HL 120; Avery Berkel, Fairmont, MN, 
USA) to measure weight, and a gauge (Holtain Limited; Crymych, Dyfed, UK) to measure 
height.
Statistical analysis plan 
Descriptive data will be presented as means + standard deviations and the Student’s t-test will 
be used to analyze statistical differences between variables. Categorical variables are 
investigated using chi-squared tests. Potential differences between intervention and control 
group will be analyzed using paired and independent t-tests. All analyses will be performed 
with SPSS version 24 (IBM Corp, Armonk, NY, USA) and Stata version 13.1 (StataCorp, 
College Station, Texas, USA).

Ethical considerations
Importance
This study could potentially lead to increased understanding of how balance exercise can 
contribute to an improved balance in individuals with impaired balance and ability. We also 
intend to highlight the participant’s confidence in, and experience of, their own balance 
ability, and if the fear of future falls is reduced. This is important knowledge in order to 
prevent falls and fall injuries in older individuals, which are expected to increase in number in 
society. Through improvements in balance, future falls can potentially be preventable, which 
contributes to less fall-related injuries and accidents, thereby maintaining functional ability in 
especially older individuals. The prevention of falls and fall injuries reduces the suffering of 
individuals, but can also reduce health care costs when care for fall injuries such as hip 
fractures can be reduced.
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