<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03227666</url>
  </required_header>
  <id_info>
    <org_study_id>VCC-LIFE-2</org_study_id>
    <nct_id>NCT03227666</nct_id>
  </id_info>
  <brief_title>Improving Balance Through Balance Exercise</brief_title>
  <official_title>The Effect of Progressive Balance Exercise on Postural Sway - a 4 Week Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Region Västerbotten</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Swedish Research Council, Kamprad Family Foundation, Kempe Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Region Västerbotten</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Today most fracture prevention measures targets the bone and osteoporosis. However, only&#xD;
      about 20% of individuals with fractures have osteoporosis and at least 90% of all fractures&#xD;
      are caused by a fall. Therefore, the present project builds on previous findings from our&#xD;
      group identifying postural sway as an important risk factor for falls and aims to intervene&#xD;
      against this risk factor in a randomized controlled trial targeting subjects at the highest&#xD;
      risk for falls.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specific aims:&#xD;
&#xD;
        1. Examine whether four weeks progressive balance training can improve parameters of body&#xD;
           sway in measurements of static standing balance&#xD;
&#xD;
        2. Investigate whether participants experience greater security to their own ability and&#xD;
           less fear of future falls after 4 weeks of progressive balance training&#xD;
&#xD;
        3. Investigate how long a potential effect of progressive balance training may be&#xD;
           noticeable on participants' experiences of greater security in their own ability and&#xD;
           less fear of future falls&#xD;
&#xD;
        4. 3. Examine whether participation in balance training leads to reduced number of falls at&#xD;
           follow-up after 6, 12 and 24 months&#xD;
&#xD;
      Falls and fall-related injuries are major health concerns for elderly individuals; they cause&#xD;
      functional decline and increased mortality, as well as incurring vast health care costs for&#xD;
      society. Occurrences and consequences of falls are expected to increase globally with the&#xD;
      growing number of elderly individuals. Hence, the improved detection and prediction of&#xD;
      potential fall risk markers are of individual and societal importance.&#xD;
&#xD;
      Falling can be the end result of intrinsic and extrinsic factors negatively affecting an&#xD;
      individual's ability to maintain balance, which are often revealed during sequences of body&#xD;
      movement. Balance can be both dynamically and statically measured, the latter involves having&#xD;
      the individual in a stationary standing position, from which results researchers have&#xD;
      proposed impaired postural stability as a risk factor for falling. However, evidence&#xD;
      regarding the association of postural instability with prospective falls is limited, and&#xD;
      population-based cohort studies in this field are scarce. Other shortcomings of previous&#xD;
      studies include the use of retrospective study designs, which increase the risks of recall&#xD;
      bias and the identification of risk factors as the result of falls.&#xD;
&#xD;
      Postural instability is preferably investigated using objective measures of posturography,&#xD;
      the advantages of which over regular clinical assessments include the reduction of test&#xD;
      performance variability and avoidance of subjective scoring systems. Recently, researchers&#xD;
      have analyzed the performance of the Wii Balance Board (WBB; Nintendo, Kyoto, Japan) in the&#xD;
      measurement of postural instability; WBB-based assessment has shown excellent concurrent&#xD;
      validity and the ability to complement existing fall assessments.&#xD;
&#xD;
      As of 2012, all 70-year olds in the Umeå municipality are invited to participate in the&#xD;
      Healthy Ageing Initiative (HAI) study, which has currently enrolled more than 3000&#xD;
      participants. Among other measurements, we include assessment of postural stability using a&#xD;
      Wii Balance Board (WBB; Nintendo, Kyoto, Japan) device. With each participant in a quiet&#xD;
      stance, balance trials consisting of 60-second eyes-open (EO) and eyes-closed (EC) trials are&#xD;
      performed. Participants are instructed to maintain an upright position throughout the test,&#xD;
      stand relaxed, and avoid any arm or head movement. The WBB measures total COP sway length,&#xD;
      representing the sum of postural sway in the anteroposterior and mediolateral directions.&#xD;
&#xD;
      Preliminary results from analyses of data consisting of 1900 70-year-old individuals revealed&#xD;
      that participants with postural sway in the 5th quintile had almost twice the risk of falling&#xD;
      compared to the reference group, when the 1-year follow-up of prospective falls was&#xD;
      performed.&#xD;
&#xD;
      Thus the aim of the present follow-up study is to investigate if the investigators can reduce&#xD;
      the increased postural sway of participants who have been identified as having abnormal&#xD;
      balance values, based on previous measurements.&#xD;
&#xD;
      The present project is planned to be conducted as a 4-week randomized intervention study with&#xD;
      a follow up time of 2 years.&#xD;
&#xD;
      Recruitment of participants at high risk of falls from the Healthy Ageing Initiative will be&#xD;
      performed. The Healthy Ageing Initiative (HAI) is an ongoing population based project aiming&#xD;
      to reduce risk factors for non-communicable diseases (NCD) by risk factor evaluation and&#xD;
      increased physical activity. In short, HAI is inviting all 70 year olds in Umeå municipality&#xD;
      to a health examination where traditional and potential novel risk factors for diabetes, CVD&#xD;
      and fractures are investigated. These include objective measures of physical activity, blood&#xD;
      pressure, blood-glucose, objective measured abdominal fat mass and ectopic fat, bone density&#xD;
      and other features of bone quality, cognitive function, balance, walking ability, and&#xD;
      different life style factors. At the second visit, all participants are informed about the&#xD;
      results of tests performed and gets advice with a focus on physical activity, aiming at&#xD;
      decreasing the risk of future diabetes, CVD and fractures. The counseling with focus on&#xD;
      physical activity is based on motivational interviewing (MI) which is a directive&#xD;
      patient-cantered counseling style to help the participants to explore and resolve their&#xD;
      ambivalence about behavior change. They are contacted at 6,12 and 24 months per telephone for&#xD;
      follow up and are contacted for an in-clinic follow up after 5 years.&#xD;
&#xD;
      Participants in HAI identified as being in the highest quartile of measures of postural sway,&#xD;
      indicating poor balance and high fall risk, are invited to participate by telephone contact,&#xD;
      and will upon agreement be randomized into either the intervention group or control group.&#xD;
      Participants will after the initial contact also receive written information about the study.&#xD;
      The investigators aim to recruit 200 individuals from the existing HAI study cohort&#xD;
&#xD;
      After 4 weeks, the participants are followed up with the same measures that are used in the&#xD;
      HAI that contains objective and functional balance tests, tests of muscle strength and a&#xD;
      validated questionnaires on fear-of-falling and physical activity. Both groups will be&#xD;
      offered the specific program for balance training post measurements, with instructions that&#xD;
      it can be performed in the home setting according to the same principles offered to the&#xD;
      intervention group. The groups are followed up after 6 and 12 months through 70-years-health&#xD;
      checks on prospective falls and levels of physical activity.&#xD;
&#xD;
      Descriptive data will be presented as M+SDs and the Student's t-test will be used to analyze&#xD;
      statistical differences between variables. Categorical variables are investigated using&#xD;
      chi-squared tests. Potential differences between intervention and control group will be&#xD;
      analyzed using paired t-tests and two-way repeated measures ANOVA. All analyses will be&#xD;
      performed with SPSS version 24 (IBM Corp, Armonk, NY, USA) and Stata version 13.1 (StataCorp,&#xD;
      College Station, Texas, USA).&#xD;
&#xD;
      This study could potentially lead to increased understanding of how balance exercise can&#xD;
      contribute to an improved balance in individuals with impaired balance and ability. The&#xD;
      investigators also intend to highlight the participant's confidence in, and experience of,&#xD;
      their own balance ability, and if the fear of future falls is reduced. This is important&#xD;
      knowledge in order to prevent falls and fall injuries in older individuals, which are&#xD;
      expected to increase in number in society. Through improvements in balance, future falls can&#xD;
      potentially be preventable, which contributes to less fall-related injuries and accidents,&#xD;
      thereby maintaining functional ability in especially older individuals. The prevention of&#xD;
      falls and fall injuries reduces the suffering of individuals, but can also reduce health care&#xD;
      costs when care for fall injuries such as hip fractures can be reduced.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Actual">August 30, 2017</completion_date>
  <primary_completion_date type="Actual">August 12, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Intervention group recieving exercise and control group recieving no exercise</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Postural Sway</measure>
    <time_frame>Change in Baseline Postural Sway at 4 weeks</time_frame>
    <description>Total postural sway length, measured objectively during trials of eyes open and eyes closed, during 60 seconds each</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prospective Falls</measure>
    <time_frame>6,12 and 24 months after intervention</time_frame>
    <description>Self-recalled during telephone follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Time-up-and-go (TUG) Performance</measure>
    <time_frame>Change in Baseline TUG Performance at 4 weeks</time_frame>
    <description>Clinical balance test assessing ability to rise from chair, walk back and forth 3 meters and sit back down</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Balance Self-efficacy</measure>
    <time_frame>Change in Baseline Balance Self-efficacy at 4 weeks</time_frame>
    <description>Falls Efficacy Scale (FES)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fear of Falling (FOF)</measure>
    <time_frame>Change in Baseline FOF at 4 weeks</time_frame>
    <description>Falls Efficacy Scale International (FES-I)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Muscle Strength</measure>
    <time_frame>Change in Baseline Muscle Strength at 4 weeks</time_frame>
    <description>Grip strength measured by isokinetic hand dynamometer</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Balance; Distorted</condition>
  <condition>Fall</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group will perform three supervised group training sessions a week, consisting of 30 minutes of balance training for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>The intervention group will perform three supervised group training sessions a week, consisting of 30 minutes of balance training for 4 weeks.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participation in the HAI study, having postural sway &gt; 400 mm during Eyes Open trial&#xD;
             or &gt; 920 mm during Eyes Closed trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Walking aid&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anna Nordström, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Västerbotten County Council, Umeå University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Livsmedicin (LIFE)</name>
      <address>
        <city>Umeå</city>
        <state>Västerbotten</state>
        <zip>907 36</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <link>
    <url>http://www.healthyageinginitiative.com</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>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.</citation>
    <PMID>14695865</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>9096540</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>9708590</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>11769786</PMID>
  </reference>
  <reference>
    <citation>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. Erratum In: Lancet. 2013 Jan 5;381(9860):28.</citation>
    <PMID>23083889</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>3205267</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>8126355</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>16439819</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>8202002</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>18324932</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>23927446</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>18789756</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24445863</PMID>
  </reference>
  <reference>
    <citation>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, Avon). 2015 Jun;30(5):481-4. doi: 10.1016/j.clinbiomech.2015.03.006. Epub 2015 Mar 11.</citation>
    <PMID>25796535</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26151120</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>27006336</PMID>
  </reference>
  <reference>
    <citation>Podsiadlo D, Richardson S. The timed &quot;Up &amp; Go&quot;: 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.</citation>
    <PMID>1991946</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>16267188</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>2229948</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>July 13, 2017</study_first_submitted>
  <study_first_submitted_qc>July 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>September 18, 2017</last_update_submitted>
  <last_update_submitted_qc>September 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Region Västerbotten</investigator_affiliation>
    <investigator_full_name>Anna Nordström</investigator_full_name>
    <investigator_title>Adjunct Professor</investigator_title>
  </responsible_party>
  <keyword>Postural sway</keyword>
  <keyword>Progressive balance exercise</keyword>
  <keyword>RCT</keyword>
  <keyword>Functional balance</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 13, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/66/NCT03227666/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form: Intervention</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 11, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/66/NCT03227666/ICF_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form: Control</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 11, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/66/NCT03227666/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03227666
org study id: VCC-LIFE-2
nct id: NCT03227666
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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

      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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Intervention group recieving exercise and control group recieving no exercise
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Change in Postural Sway
time frame: Change in Baseline Postural Sway at 4 weeks
description: Total postural sway length, measured objectively during trials of eyes open and eyes closed, during 60 seconds each
measure: Prospective Falls
time frame: 6,12 and 24 months after intervention
description: Self-recalled during telephone follow-up
measure: Change in Time-up-and-go (TUG) Performance
time frame: Change in Baseline TUG Performance at 4 weeks
description: Clinical balance test assessing ability to rise from chair, walk back and forth 3 meters and sit back down
measure: Change in Balance Self-efficacy
time frame: Change in Baseline Balance Self-efficacy at 4 weeks
description: Falls Efficacy Scale (FES)
measure: Change in Fear of Falling (FOF)
time frame: Change in Baseline FOF at 4 weeks
description: Falls Efficacy Scale International (FES-I)
measure: Change in Muscle Strength
time frame: Change in Baseline Muscle Strength at 4 weeks
description: Grip strength measured by isokinetic hand dynamometer
arm group label: Intervention Group
arm group type: Experimental
description: The intervention group will perform three supervised group training sessions a week, consisting of 30 minutes of balance training for 4 weeks.
arm group label: Control group
arm group type: No Intervention
description: 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.
intervention type: Behavioral
intervention name: Exercise
description: The intervention group will perform three supervised group training sessions a week, consisting of 30 minutes of balance training for 4 weeks.
arm group label: Intervention Group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Anna Nordström, PhD
role: Principal Investigator
affiliation: Västerbotten County Council, Umeå University
facility: 
country: Sweden
url: http://www.healthyageinginitiative.com
description: Related Info
citation: 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.
PMID: 14695865
citation: 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.
PMID: 9096540
citation: 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.
PMID: 9708590
citation: 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.
PMID: 11769786
citation: 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. Erratum In: Lancet. 2013 Jan 5;381(9860):28.
PMID: 23083889
citation: 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.
PMID: 3205267
citation: 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.
PMID: 8126355
citation: 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.
PMID: 16439819
citation: 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.
PMID: 8202002
citation: 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.
PMID: 18324932
citation: 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.
PMID: 23927446
citation: 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.
PMID: 18789756
citation: 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.
PMID: 24445863
citation: 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, Avon). 2015 Jun;30(5):481-4. doi: 10.1016/j.clinbiomech.2015.03.006. Epub 2015 Mar 11.
PMID: 25796535
citation: 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.
PMID: 26151120
citation: 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.
PMID: 27006336
citation: 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.
PMID: 1991946
citation: 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.
PMID: 16267188
citation: 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.
PMID: 2229948
responsible party type: Principal Investigator
investigator affiliation: Region Västerbotten
investigator full name: Anna Nordström
investigator title: Adjunct Professor
sharing ipd: No
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