Study Results
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Basic Information
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COMPLETED
NA
52 participants
INTERVENTIONAL
2017-04-01
2017-08-30
Brief Summary
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Detailed Description
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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
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. 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, which are often revealed during sequences of body movement. 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. However, evidence regarding the association of postural instability with prospective falls is limited, and population-based cohort studies in this field are scarce. Other shortcomings of previous studies include the use of retrospective study designs, which increase the risks of recall bias and the identification of risk factors as the result of falls.
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. 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.
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 analyses 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 the investigators can reduce the increased postural sway of participants who have been identified as having abnormal balance values, based on previous measurements.
The present project is planned to be conducted as a 4-week randomized intervention study with a follow up time of 2 years.
Recruitment of participants at high risk of falls from the Healthy Ageing Initiative will be performed. 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. 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 6,12 and 24 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. The investigators aim to recruit 200 individuals from the existing HAI study cohort
After 4 weeks, the participants are followed up with the same measures that are used in the HAI 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.
Descriptive data will be presented as M+SDs 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 t-tests and two-way repeated measures ANOVA. All analyses will be performed with SPSS version 24 (IBM Corp, Armonk, NY, USA) and Stata version 13.1 (StataCorp, College Station, Texas, USA).
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. The investigators 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Intervention Group
The intervention group will perform three supervised group training sessions a week, consisting of 30 minutes of balance training for 4 weeks.
Exercise
The intervention group will perform three supervised group training sessions a week, consisting of 30 minutes of balance training for 4 weeks.
Control group
The control group recieves 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.
No interventions assigned to this group
Interventions
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Exercise
The intervention group will perform three supervised group training sessions a week, consisting of 30 minutes of balance training for 4 weeks.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Swedish Research Council, Kamprad Family Foundation, Kempe Foundation
UNKNOWN
Region Västerbotten
OTHER_GOV
Responsible Party
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Anna Nordström
Adjunct Professor
Principal Investigators
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Anna Nordström, PhD
Role: PRINCIPAL_INVESTIGATOR
Västerbotten County Council, Umeå University
Locations
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Livsmedicin (LIFE)
Umeå, Västerbotten County, Sweden
Countries
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References
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Stel VS, Smit JH, Pluijm SM, Lips P. Consequences of falling in older men and women and risk factors for health service use and functional decline. Age Ageing. 2004 Jan;33(1):58-65. doi: 10.1093/ageing/afh028.
Wolinsky FD, Fitzgerald JF, Stump TE. The effect of hip fracture on mortality, hospitalization, and functional status: a prospective study. Am J Public Health. 1997 Mar;87(3):398-403. doi: 10.2105/ajph.87.3.398.
Rizzo JA, Friedkin R, Williams CS, Nabors J, Acampora D, Tinetti ME. Health care utilization and costs in a Medicare population by fall status. Med Care. 1998 Aug;36(8):1174-88. doi: 10.1097/00005650-199808000-00006.
Masud T, Morris RO. Epidemiology of falls. Age Ageing. 2001 Nov;30 Suppl 4:3-7. doi: 10.1093/ageing/30.suppl_4.3. No abstract available.
Robinovitch SN, Feldman F, Yang Y, Schonnop R, Leung PM, Sarraf T, Sims-Gould J, Loughin M. Video capture of the circumstances of falls in elderly people residing in long-term care: an observational study. Lancet. 2013 Jan 5;381(9860):47-54. doi: 10.1016/S0140-6736(12)61263-X. Epub 2012 Oct 17.
Tinetti ME, Speechley M, Ginter SF. Risk factors for falls among elderly persons living in the community. N Engl J Med. 1988 Dec 29;319(26):1701-7. doi: 10.1056/NEJM198812293192604.
Maki BE, Holliday PJ, Topper AK. A prospective study of postural balance and risk of falling in an ambulatory and independent elderly population. J Gerontol. 1994 Mar;49(2):M72-84. doi: 10.1093/geronj/49.2.m72.
Piirtola M, Era P. Force platform measurements as predictors of falls among older people - a review. Gerontology. 2006;52(1):1-16. doi: 10.1159/000089820.
Lord SR, Sambrook PN, Gilbert C, Kelly PJ, Nguyen T, Webster IW, Eisman JA. Postural stability, falls and fractures in the elderly: results from the Dubbo Osteoporosis Epidemiology Study. Med J Aust. 1994 Jun 6;160(11):684-5, 688-91.
Moe-Nilssen R, Nordin E, Lundin-Olsson L; Work Package 3 of European Community Research Network Prevention of Falls Network Europe. Criteria for evaluation of measurement properties of clinical balance measures for use in fall prevention studies. J Eval Clin Pract. 2008 Apr;14(2):236-40. doi: 10.1111/j.1365-2753.2007.00839.x.
Howcroft J, Kofman J, Lemaire ED. Review of fall risk assessment in geriatric populations using inertial sensors. J Neuroeng Rehabil. 2013 Aug 8;10(1):91. doi: 10.1186/1743-0003-10-91.
Visser JE, Carpenter MG, van der Kooij H, Bloem BR. The clinical utility of posturography. Clin Neurophysiol. 2008 Nov;119(11):2424-36. doi: 10.1016/j.clinph.2008.07.220. Epub 2008 Sep 12.
Scaglioni-Solano P, Aragon-Vargas LF. Validity and reliability of the Nintendo Wii Balance Board to assess standing balance and sensory integration in highly functional older adults. Int J Rehabil Res. 2014 Jun;37(2):138-43. doi: 10.1097/MRR.0000000000000046.
Kwok BC, Clark RA, Pua YH. Novel use of the Wii Balance Board to prospectively predict falls in community-dwelling older adults. Clin Biomech (Bristol). 2015 Jun;30(5):481-4. doi: 10.1016/j.clinbiomech.2015.03.006. Epub 2015 Mar 11.
Johansson J, Nordstrom A, Nordstrom P. Objectively measured physical activity is associated with parameters of bone in 70-year-old men and women. Bone. 2015 Dec;81:72-79. doi: 10.1016/j.bone.2015.07.001. Epub 2015 Jul 4.
Johansson J, Nordstrom A, Nordstrom P. Greater Fall Risk in Elderly Women Than in Men Is Associated With Increased Gait Variability During Multitasking. J Am Med Dir Assoc. 2016 Jun 1;17(6):535-40. doi: 10.1016/j.jamda.2016.02.009. Epub 2016 Mar 19.
Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
Yardley L, Beyer N, Hauer K, Kempen G, Piot-Ziegler C, Todd C. Development and initial validation of the Falls Efficacy Scale-International (FES-I). Age Ageing. 2005 Nov;34(6):614-9. doi: 10.1093/ageing/afi196.
Tinetti ME, Richman D, Powell L. Falls efficacy as a measure of fear of falling. J Gerontol. 1990 Nov;45(6):P239-43. doi: 10.1093/geronj/45.6.p239.
Sorlen N, Hult A, Nordstrom P, Nordstrom A, Johansson J. Short-term balance training and acute effects on postural sway in balance-deficient older adults: a randomized controlled trial. BMC Sports Sci Med Rehabil. 2021 Mar 9;13(1):23. doi: 10.1186/s13102-021-00251-x.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form: Intervention
Document Type: Informed Consent Form: Control
Related Links
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Related Info
Other Identifiers
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VCC-LIFE-2
Identifier Type: -
Identifier Source: org_study_id