xml: <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/NCT05965011</url>
    </required_header>
    <id_info>
      <org_study_id>6030812</org_study_id>
      <nct_id>NCT05965011</nct_id>
    </id_info>
    <brief_title>Nordic Walking to Manage Falls and Fear of Falling</brief_title>
    <official_title>Walking on 'Four Legs' to Manage Falls and Fear of Falling</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Queen's University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Queen's University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        This is a pilot study that aims to test the feasibility and safety of a novel Nordic Walking&#xD;
        (NW) activity program for community-dwelling older adults who are at risk of falling or&#xD;
        experience fear of falling (FOF). The study also aims to determine the distribution and&#xD;
        effect sizes of outcomes to inform future sample size calculations and explore participants'&#xD;
        perspectives of the intervention.&#xD;
  &#xD;
        Participants will be asked to:&#xD;
  &#xD;
          -  Attend training sessions to learn proper Nordic Walking techniques.&#xD;
  &#xD;
          -  Engage in supervised Nordic Walking sessions for a specified duration and frequency.&#xD;
  &#xD;
          -  Keep a log of their walking activities and any falls or near falls experienced.&#xD;
  &#xD;
          -  Complete questionnaires to assess their fear of falling and overall physical activity&#xD;
             levels.&#xD;
  &#xD;
        If there is a comparison group:&#xD;
  &#xD;
        Researchers will compare the intervention group, consisting of older adults participating in&#xD;
        the Nordic Walking program, with a control group of older adults who do not receive the&#xD;
        intervention. The comparison will be made to determine if Nordic Walking has a significant&#xD;
        impact on reducing falls and fear of falling compared to the control group.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Introduction:&#xD;
  &#xD;
        this is a pilot study that aims to test the feasibility and safety of a novel Nordic Walking&#xD;
        (NW) activity program for community-dwelling older adults who are at risk of falling or&#xD;
        experience fear of falling (FOF). The study also aims to determine the distribution and&#xD;
        effect sizes of outcomes to inform future sample size calculations and explore participants'&#xD;
        perspectives of the intervention.&#xD;
  &#xD;
        Background:&#xD;
  &#xD;
        Falls and fear of falling are significant concerns among older adults, leading to physical&#xD;
        impairments, psychological trauma, and a decline in abilities and quality of life. Exercise&#xD;
        has been shown to be effective in improving muscle strength, balance, mobility, and postural&#xD;
        control, all of which are risk factors for falls and FOF. However, traditional exercise&#xD;
        programs have limitations in terms of cost, sustainability, and long-term adherence. Nordic&#xD;
        Walking, a low-risk and low-tech intervention, has emerged as a promising alternative,&#xD;
        offering numerous physical and mental health benefits.&#xD;
  &#xD;
        Study Design:&#xD;
  &#xD;
        The study will be conducted in two stages. Stage One will involve a two-arm, parallel,&#xD;
        single-blind, randomized controlled pilot trial. Forty older adults at risk of falling will&#xD;
        be recruited and randomly assigned to either a 10-week NW intervention group or a control&#xD;
        group. The intervention group will receive supervised NW training sessions and will be&#xD;
        coached to practice independently. The control group will receive regular phone calls to&#xD;
        discuss healthy lifestyle habits.&#xD;
  &#xD;
        Outcome Measures:&#xD;
  &#xD;
        The study will collect feasibility and safety data, including recruitment, adherence, and&#xD;
        follow-up rates, as well as adverse events. Effectiveness outcomes will be assessed using&#xD;
        measures such as the Timed Up and Go (TUG) test, Stay Independent Falls Risk Assessment Tool,&#xD;
        Falls Efficacy Scale-International (FES-I), Activities-Specific Balance Confidence Scale, and&#xD;
        the Four-Square Step Test (FSST).&#xD;
  &#xD;
        Data Analysis:&#xD;
  &#xD;
        Descriptive statistics will be used to characterize participants and feasibility measures.&#xD;
        Hedge's effect size and confidence intervals will be calculated. Independent samples t-tests&#xD;
        and chi-square tests will be used to compare the intervention and control groups. The main&#xD;
        focus of the analysis will be to estimate the effect size, test the intervention's&#xD;
        feasibility and safety, and inform future studies.&#xD;
  &#xD;
        Sample Size:&#xD;
  &#xD;
        The study aims to recruit 40 participants (20 per group) to ensure study robustness and&#xD;
        account for potential dropouts.&#xD;
  &#xD;
        Stage Two:&#xD;
  &#xD;
        In the second stage, qualitative interviews will be conducted with all participants in the&#xD;
        intervention group to gather feedback on the acceptability, perceived value, barriers, and&#xD;
        facilitators of participating. The data will be analyzed using interpretive description to&#xD;
        identify themes and categories.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 29, 2022</start_date>
    <completion_date type="Anticipated">January 2024</completion_date>
    <primary_completion_date type="Anticipated">September 2023</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>This study will be a pilot trial conducted as a two-arm, parallel, single-blind, randomized controlled trial.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>The single-blind design will involve that the assessors are unaware of the group assignments.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Estimate the effect size of intervention (Cohen's D)</measure>
      <time_frame>Through study completion, an average of 1.5 years</time_frame>
      <description>Effect size estimation is vital in assessing the impact of interventions like Nordic walking and planning future studies. It involves quantifying the magnitude of the intervention's effect on the outcome variable.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Evaluate the adherence rate to the intervention (as a measure of feasibility)</measure>
      <time_frame>Through study completion, an average of 1.5 years</time_frame>
      <description>Participant Adherence to the Intervention: This measure examines the extent to which participants adhere to the prescribed Nordic walking program. It involves tracking the frequency, duration, and intensity of Nordic walking sessions completed by participants. Adherence rates can be calculated based on the number of sessions attended or completed as planned.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assess safety of the intervention</measure>
      <time_frame>Through study completion, an average of 1.5 years</time_frame>
      <description>Monitoring Adverse Events: We systematically record and monitor any adverse events or incidents during the study. This includes injuries, discomfort, or any negative effects reported by participants.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Timed Up and Go (TUG) to assess fall risk</measure>
      <time_frame>Pre (week 0) /post intervention (week 11)</time_frame>
      <description>The Timed Up and Go (TUG) test is a widely used clinical assessment tool to evaluate mobility and functional mobility, specifically in older adults. While it is not specifically designed to determine the risk of falling, it can provide valuable information that is correlated with fall risk. The TUG test measures the time it takes for an individual to stand up from a chair, walk a set distance (typically 3 meters), turn around, return to the chair, and sit down again.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fear of Falling: Fear of falling will be measured by the Falls Efficacy Scale-International (FES-I)</measure>
      <time_frame>Pre (week 0) /post intervention (week 11)</time_frame>
      <description>Scale: Falls Efficacy Scale-International (FES-I) Minimum Value: 0 (not at all confident) Maximum Value: 100 (completely confident) Interpretation: In the FES-I, higher scores indicate greater fear of falling. Therefore, a higher score on the FES-I reflects a worse outcome, indicating a higher level of fear and reduced confidence in performing daily activities without falling. Conversely, a lower score on the FES-I suggests a better outcome, indicating a lower level of fear and greater confidence in performing activities without fear of falling.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Performance on the Four-Square Step Test (FSST) will be measured to assess balance.</measure>
      <time_frame>Pre (week 0) /post intervention (week 11)</time_frame>
      <description>The Four-Square Step Test (FSST) does not yield a specific score on a scale like some other assessments. Instead, the FSST primarily focuses on the time taken to complete the test and the occurrence of errors or missteps.&#xD;
  When assessing FSST performance, the following information is typically recorded:&#xD;
  Completion Time: The time the individual takes to complete the FSST is measured in seconds. A shorter completion time generally indicates better balance and agility.&#xD;
  Errors or Missteps: The number of errors or missteps made by the individual during the FSST is recorded. Errors can include stepping outside the designated squares, incorrect foot placement, or loss of balance. Fewer errors suggest better balance control and coordination.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Risk of Falling</condition>
    <arm_group>
      <arm_group_label>Intervention (Nordic walking)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Nordic walking training. These coaching principles will focus on highlighting the participants' strengths and resourcefulness, setting goals, and utilizing solution-focused problem-solving techniques to achieve those goals during practice and related activities . This group sessions will be conducted biweekly to ensure appropriate progression and adherence to the guidelines set by the International Nordic Walking Federation.&#xD;
  In addition to the supervised group sessions, participants will also receive supervised NW training from a certified NW instructor. Participants will be encouraged to set goals and develop strategies to facilitate independent practice for at least three 30-minute sessions per week over a period of 10 weeks. These unsupervised sessions aim to encourage participants to engage in regular practice outside of the group sessions.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control (phone calls)</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The control group will receive regular contact to control for attention and maintain participant engagement throughout the study. Over the course of the 10 weeks, participants in this group will receive 5 biweekly phone calls from the study's graduate research assistant (RA).&#xD;
  During each phone call, the RA will engage in discussions with participants about leading a healthy lifestyle in general, covering topics such as proper nutrition and adequate sleep. Additionally, the RA will gather safety-related data, including information on any falls that may have occurred. The phone calls will also serve as reminders for participants about upcoming assessments and their importance in the study. The investigators will provide a training session to the control group following the completion of the study if they are interested.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Exercise training</intervention_name>
      <description>The intervention will be a combination of both supervised and unsupervised sessions. Participants in the Nordic Walking (NW) treatment group will attend 5 one-hour group sessions, which will incorporate coaching principles.</description>
      <arm_group_label>Intervention (Nordic walking)</arm_group_label>
      <other_name>Nordic walking</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Must be 60+ years old.&#xD;
  &#xD;
            -  Be at risk of falling, as determined by the Stay Independent Falls Risk Assessment&#xD;
               Tool. This validated tool is recommended by the STEADI fall prevention program to&#xD;
               evaluate risk of falling.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Inability to use walking poles due to medical conditions.&#xD;
  &#xD;
            -  Inability to walk 400m independently.&#xD;
  &#xD;
            -  Having a medical condition such as unstable cardiorespiratory status, impending&#xD;
               angioplasty, or ataxia/dyskinesia (unsteady, staggering gait) that prevents them from&#xD;
               participating in physical activities or using walking poles is prohibited.&#xD;
  &#xD;
            -  Taking part in any other structured exercise program.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Mohammad Auais, BSc PT, MSc PT, PhD</last_name>
      <phone>613-533-3112</phone>
      <phone_ext>33112</phone_ext>
      <email>mohammad.auais@queensu.ca</email>
    </overall_contact>
    <location>
      <facility>
        <name>School of Rehabilitation Therapy, Queens University</name>
        <address>
          <city>Kingston</city>
          <state>Ontario</state>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mohammad Auais, BSc PT, MSc PT, PhD</last_name>
        <phone>6135333112</phone>
        <email>mohammad.auais@queensu.ca</email>
      </contact>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <reference>
      <citation>Hughes VA, Frontera WR, Wood M, Evans WJ, Dallal GE, Roubenoff R, Fiatarone Singh MA. Longitudinal muscle strength changes in older adults: influence of muscle mass, physical activity, and health. J Gerontol A Biol Sci Med Sci. 2001 May;56(5):B209-17. doi: 10.1093/gerona/56.5.b209.</citation>
      <PMID>11320101</PMID>
    </reference>
    <reference>
      <citation>Krasovsky T, Banina MC, Hacmon R, Feldman AG, Lamontagne A, Levin MF. Stability of gait and interlimb coordination in older adults. J Neurophysiol. 2012 May;107(9):2560-9. doi: 10.1152/jn.00950.2011. Epub 2012 Feb 1.</citation>
      <PMID>22298827</PMID>
    </reference>
    <reference>
      <citation>Herman T, Giladi N, Gurevich T, Hausdorff JM. Gait instability and fractal dynamics of older adults with a &quot;cautious&quot; gait: why do certain older adults walk fearfully? Gait Posture. 2005 Feb;21(2):178-85. doi: 10.1016/j.gaitpost.2004.01.014.</citation>
      <PMID>15639397</PMID>
    </reference>
    <reference>
      <citation>Beauchet O, Annweiler C, Allali G, Berrut G, Herrmann FR, Dubost V. Recurrent falls and dual task-related decrease in walking speed: is there a relationship? J Am Geriatr Soc. 2008 Jul;56(7):1265-9. doi: 10.1111/j.1532-5415.2008.01766.x. Epub 2008 May 26.</citation>
      <PMID>18510582</PMID>
    </reference>
    <reference>
      <citation>Bertera EM, Bertera RL. Fear of falling and activity avoidance in a national sample of older adults in the United States. Health Soc Work. 2008 Feb;33(1):54-62. doi: 10.1093/hsw/33.1.54.</citation>
      <PMID>18326450</PMID>
    </reference>
    <reference>
      <citation>Keast M-L. Nordic walking: introducing a new low-impact exercise system for cardiac rehabilitation patients. Minto prevention and rehabilitation center, University of Ottawa Heart Institute. 2009:13- 14.</citation>
    </reference>
    <reference>
      <citation>Ossowski Z, Wawryniku M, Česnaitiene V. Influence of nordic walking training on static and dynamic body balance among the elderly. Baltic Journal of Health and Physical Activity. 2015;7(1):72-80.</citation>
    </reference>
    <reference>
      <citation>Karawan A, Porcari J, Butta H, Postmus A, Stoughton L, Larkin J. Effects of 12 weeks of walking or exerstriding on upper body strength and endurance. Medicine &amp; Science in Sports &amp; Exercise. 1992;24(5):S138.</citation>
    </reference>
    <reference>
      <citation>Kortas J, Kuchta A, Prusik K, Prusik K, Ziemann E, Labudda S, Cwiklinska A, Wieczorek E, Jankowski M, Antosiewicz J. Nordic walking training attenuation of oxidative stress in association with a drop in body iron stores in elderly women. Biogerontology. 2017 Aug;18(4):517-524. doi: 10.1007/s10522-017-9681-0. Epub 2017 Feb 22.</citation>
      <PMID>28229255</PMID>
    </reference>
    <reference>
      <citation>Dalton C, Nantel J. Nordic Walking Improves Postural Alignment and Leads to a More Normal Gait Pattern Following Weeks of Training: A Pilot Study. J Aging Phys Act. 2016 Oct;24(4):575-582. doi: 10.1123/japa.2015-0204. Epub 2016 Aug 24.</citation>
      <PMID>27051072</PMID>
    </reference>
    <reference>
      <citation>Willson J, Torry MR, Decker MJ, Kernozek T, Steadman JR. Effects of walking poles on lower extremity gait mechanics. Med Sci Sports Exerc. 2001 Jan;33(1):142-7. doi: 10.1097/00005768-200101000-00021.</citation>
      <PMID>11194099</PMID>
    </reference>
    <reference>
      <citation>Reelick MF, van Iersel MB, Kessels RP, Rikkert MG. The influence of fear of falling on gait and balance in older people. Age Ageing. 2009 Jul;38(4):435-40. doi: 10.1093/ageing/afp066. Epub 2009 May 18.</citation>
      <PMID>19451658</PMID>
    </reference>
    <reference>
      <citation>Rubenstein LZ, Vivrette R, Harker JO, Stevens JA, Kramer BJ. Validating an evidence-based, self-rated fall risk questionnaire (FRQ) for older adults. J Safety Res. 2011 Dec;42(6):493-9. doi: 10.1016/j.jsr.2011.08.006. Epub 2011 Nov 17.</citation>
      <PMID>22152267</PMID>
    </reference>
    <reference>
      <citation>Stevens JA. The STEADI Tool Kit: A Fall Prevention Resource for Health Care Providers. IHS Prim Care Provid. 2013 Sep;39(9):162-166. No abstract available.</citation>
      <PMID>26766893</PMID>
    </reference>
    <reference>
      <citation>van Zyl LE, Roll LC, Stander MW, Richter S. Positive Psychological Coaching Definitions and Models: A Systematic Literature Review. Front Psychol. 2020 May 6;11:793. doi: 10.3389/fpsyg.2020.00793. eCollection 2020.</citation>
      <PMID>32435218</PMID>
    </reference>
    <reference>
      <citation>International Nordic Walking Federation. http://inwa-nordicwalking.com/. Accessed May 2021.</citation>
    </reference>
    <reference>
      <citation>Bullo V, Gobbo S, Vendramin B, Duregon F, Cugusi L, Di Blasio A, Bocalini DS, Zaccaria M, Bergamin M, Ermolao A. Nordic Walking Can Be Incorporated in the Exercise Prescription to Increase Aerobic Capacity, Strength, and Quality of Life for Elderly: A Systematic Review and Meta-Analysis. Rejuvenation Res. 2018 Apr;21(2):141-161. doi: 10.1089/rej.2017.1921. Epub 2017 Nov 20.</citation>
      <PMID>28756746</PMID>
    </reference>
    <reference>
      <citation>Shumway-Cook A, Brauer S, Woollacott M. Predicting the probability for falls in community-dwelling older adults using the Timed Up &amp; Go Test. Phys Ther. 2000 Sep;80(9):896-903.</citation>
      <PMID>10960937</PMID>
    </reference>
    <reference>
      <citation>Delbaere K, Close JC, Mikolaizak AS, Sachdev PS, Brodaty H, Lord SR. The Falls Efficacy Scale International (FES-I). A comprehensive longitudinal validation study. Age Ageing. 2010 Mar;39(2):210-6. doi: 10.1093/ageing/afp225. Epub 2010 Jan 8.</citation>
      <PMID>20061508</PMID>
    </reference>
    <reference>
      <citation>Powell LE, Myers AM. The Activities-specific Balance Confidence (ABC) Scale. J Gerontol A Biol Sci Med Sci. 1995 Jan;50A(1):M28-34. doi: 10.1093/gerona/50a.1.m28.</citation>
      <PMID>7814786</PMID>
    </reference>
    <reference>
      <citation>Dite W, Temple VA. A clinical test of stepping and change of direction to identify multiple falling older adults. Arch Phys Med Rehabil. 2002 Nov;83(11):1566-71. doi: 10.1053/apmr.2002.35469.</citation>
      <PMID>12422327</PMID>
    </reference>
    <reference>
      <citation>Sullivan GM, Feinn R. Using Effect Size-or Why the P Value Is Not Enough. J Grad Med Educ. 2012 Sep;4(3):279-82. doi: 10.4300/JGME-D-12-00156.1. No abstract available.</citation>
      <PMID>23997866</PMID>
    </reference>
    <reference>
      <citation>Mangione KK, Craik RL, Palombaro KM, Tomlinson SS, Hofmann MT. Home-based leg-strengthening exercise improves function 1 year after hip fracture: a randomized controlled study. J Am Geriatr Soc. 2010 Oct;58(10):1911-7. doi: 10.1111/j.1532-5415.2010.03076.x.</citation>
      <PMID>20929467</PMID>
    </reference>
    <reference>
      <citation>Moore CG, Carter RE, Nietert PJ, Stewart PW. Recommendations for planning pilot studies in clinical and translational research. Clin Transl Sci. 2011 Oct;4(5):332-7. doi: 10.1111/j.1752-8062.2011.00347.x.</citation>
      <PMID>22029804</PMID>
    </reference>
    <reference>
      <citation>Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics: The Journal of Applied Statistics in the Pharmaceutical Industry. 2005;4(4):287-291.</citation>
    </reference>
    <reference>
      <citation>Thorne S, Kirkham SR, MacDonald-Emes J. Interpretive description: a noncategorical qualitative alternative for developing nursing knowledge. Res Nurs Health. 1997 Apr;20(2):169-77. doi: 10.1002/(sici)1098-240x(199704)20:23.0.co;2-i.</citation>
      <PMID>9100747</PMID>
    </reference>
    <reference>
      <citation>Soriano TA, DeCherrie LV, Thomas DC. Falls in the community-dwelling older adult: a review for primary-care providers. Clin Interv Aging. 2007;2(4):545-54. doi: 10.2147/cia.s1080.</citation>
      <PMID>18225454</PMID>
    </reference>
    <reference>
      <citation>Parachute. Fall prevention. 2014. https://parachute.ca/en/injury-topic/fall-prevention-for-seniors/. Accessed Mar 2021</citation>
    </reference>
    <reference>
      <citation>Falls: Assessment and Prevention of Falls in Older People. London: National Institute for Health and Care Excellence (NICE); 2013 Jun. Available from http://www.ncbi.nlm.nih.gov/books/NBK258885/</citation>
      <PMID>25506960</PMID>
    </reference>
    <reference>
      <citation>Tinetti ME, Powell L. Fear of falling and low self-efficacy: a case of dependence in elderly persons. J Gerontol. 1993 Sep;48 Spec No:35-8. doi: 10.1093/geronj/48.special_issue.35. No abstract available.</citation>
      <PMID>8409238</PMID>
    </reference>
    <reference>
      <citation>Mane AB, Sanjana T, Patil PR, Sriniwas T. Prevalence and correlates of fear of falling among elderly population in urban area of Karnataka, India. J Midlife Health. 2014 Jul;5(3):150-5. doi: 10.4103/0976-7800.141224.</citation>
      <PMID>25317002</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>
    <reference>
      <citation>Murphy SL, Dubin JA, Gill TM. The development of fear of falling among community-living older women: predisposing factors and subsequent fall events. J Gerontol A Biol Sci Med Sci. 2003 Oct;58(10):M943-7. doi: 10.1093/gerona/58.10.m943.</citation>
      <PMID>14570863</PMID>
    </reference>
    <reference>
      <citation>Auais M, French S, Alvarado B, Pirkle C, Belanger E, Guralnik J. Fear of Falling Predicts Incidence of Functional Disability 2 Years Later: A Perspective From an International Cohort Study. J Gerontol A Biol Sci Med Sci. 2018 Aug 10;73(9):1212-1215. doi: 10.1093/gerona/glx237.</citation>
      <PMID>29220420</PMID>
    </reference>
    <reference>
      <citation>Parker SG, Corner L, Laing K, Nestor G, Craig D, Collerton J, Frith J, Roberts HC, Sayer AA, Allan LM, Robinson L, Cowan K; multiple conditions in later life priority setting partnership. Priorities for research in multiple conditions in later life (multi-morbidity): findings from a James Lind Alliance Priority Setting Partnership. Age Ageing. 2019 May 1;48(3):401-406. doi: 10.1093/ageing/afz014.</citation>
      <PMID>30892604</PMID>
    </reference>
    <reference>
      <citation>Rimer J, Dwan K, Lawlor DA, Greig CA, McMurdo M, Morley W, Mead GE. Exercise for depression. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD004366. doi: 10.1002/14651858.CD004366.pub5.</citation>
      <PMID>22786489</PMID>
    </reference>
    <reference>
      <citation>Bula CJ, Monod S, Hoskovec C, Rochat S. Interventions aiming at balance confidence improvement in older adults: an updated review. Gerontology. 2011;57(3):276-86. doi: 10.1159/000322241. Epub 2010 Oct 29.</citation>
      <PMID>21042008</PMID>
    </reference>
    <reference>
      <citation>Howe TE, Rochester L, Neil F, Skelton DA, Ballinger C. Exercise for improving balance in older people. Cochrane Database Syst Rev. 2011 Nov 9;(11):CD004963. doi: 10.1002/14651858.CD004963.pub3.</citation>
      <PMID>22071817</PMID>
    </reference>
    <reference>
      <citation>Huang TT, Yang LH, Liu CY. Reducing the fear of falling among community-dwelling elderly adults through cognitive-behavioural strategies and intense Tai Chi exercise: a randomized controlled trial. J Adv Nurs. 2011 May;67(5):961-71. doi: 10.1111/j.1365-2648.2010.05553.x. Epub 2011 Jan 7.</citation>
      <PMID>21214623</PMID>
    </reference>
    <reference>
      <citation>Watzek D, Mischler E, Sonam D, et al. Effectiveness and economic evaluation of therapeutic nordic walking in patients with psychosomatic disorders: A pragmatic randomized controlled trial. Psychology. 2016;6(11):665-675.</citation>
    </reference>
    <reference>
      <citation>Finnegan S, Bruce J, Skelton DA, Withers EJ, Lamb SE; PreFIT Study Group. Development and delivery of an exercise programme for falls prevention: the Prevention of Falls Injury Trial (PreFIT). Physiotherapy. 2018 Mar;104(1):72-79. doi: 10.1016/j.physio.2017.06.004. Epub 2017 Jun 27.</citation>
      <PMID>28801033</PMID>
    </reference>
    <reference>
      <citation>Thompson PD, Arena R, Riebe D, Pescatello LS; American College of Sports Medicine. ACSM's new preparticipation health screening recommendations from ACSM's guidelines for exercise testing and prescription, ninth edition. Curr Sports Med Rep. 2013 Jul-Aug;12(4):215-7. doi: 10.1249/JSR.0b013e31829a68cf. No abstract available.</citation>
      <PMID>23851406</PMID>
    </reference>
    <reference>
      <citation>Yamauchi T, Islam MM, Koizumi D, Rogers ME, Rogers NL, Takeshima N. Effect of home-based well-rounded exercise in community-dwelling older adults. J Sports Sci Med. 2005 Dec 1;4(4):563-71. eCollection 2005 Dec.</citation>
      <PMID>24501569</PMID>
    </reference>
    <reference>
      <citation>Dishman RK. Increasing and maintaining exercise and physical activity. Behavior Therapy. 1991;22(3):345-378. 10</citation>
    </reference>
    <reference>
      <citation>Cyarto EV, Brown WJ, Marshall AL. Retention, adherence and compliance: important considerations for home- and group-based resistance training programs for older adults. J Sci Med Sport. 2006 Oct;9(5):402-12. doi: 10.1016/j.jsams.2006.06.020. Epub 2006 Sep 5.</citation>
      <PMID>16911871</PMID>
    </reference>
    <reference>
      <citation>Yan T, Wilber KH, Simmons WJ. Motivating high-risk older adults to exercise: does coaching matter? Home Health Care Serv Q. 2011 Apr;30(2):84-95. doi: 10.1080/01621424.2011.569670.</citation>
      <PMID>21590567</PMID>
    </reference>
    <reference>
      <citation>Church TS, Earnest CP, Morss GM. Field testing of physiological responses associated with Nordic Walking. Res Q Exerc Sport. 2002 Sep;73(3):296-300. doi: 10.1080/02701367.2002.10609023.</citation>
      <PMID>12230336</PMID>
    </reference>
    <reference>
      <citation>Jordan AN, Olson TP, Earnest CP, Morss GM, Church TS. Metabolic cost of high intensity poling while nordic walking versus normal walking. Medicine &amp; Science in Sports &amp; Exercise. 2001;33(5):S86.</citation>
    </reference>
    <reference>
      <citation>Figard-Fabre H, Fabre N, Leonardi A, Schena F. Physiological and perceptual responses to Nordic walking in obese middle-aged women in comparison with the normal walk. Eur J Appl Physiol. 2010 Apr;108(6):1141-51. doi: 10.1007/s00421-009-1315-z. Epub 2009 Dec 20.</citation>
      <PMID>20091181</PMID>
    </reference>
    <reference>
      <citation>Mikalacki M, Cokorilo N, Katic R. Effect of nordic walking on functional ability and blood pressure in elderly women. Coll Antropol. 2011 Sep;35(3):889-94.</citation>
      <PMID>22053573</PMID>
    </reference>
    <reference>
      <citation>Bulinska K, Kropielnicka K, Jasinski T, Wojcieszczyk-Latos J, Pilch U, Dabrowska G, Skorkowska-Telichowska K, Kalka D, Zywar K, Paszkowski R, Wozniewski M, Szuba A, Jasinski R. Nordic pole walking improves walking capacity in patients with intermittent claudication: a randomized controlled trial. Disabil Rehabil. 2016;38(13):1318-24. doi: 10.3109/09638288.2015.1077398. Epub 2015 Aug 25.</citation>
      <PMID>26305413</PMID>
    </reference>
    <reference>
      <citation>Breyer MK, Breyer-Kohansal R, Funk GC, Dornhofer N, Spruit MA, Wouters EF, Burghuber OC, Hartl S. Nordic walking improves daily physical activities in COPD: a randomised controlled trial. Respir Res. 2010 Aug 22;11(1):112. doi: 10.1186/1465-9921-11-112.</citation>
      <PMID>20727209</PMID>
    </reference>
    <reference>
      <citation>van Eijkeren FJ, Reijmers RS, Kleinveld MJ, Minten A, Bruggen JP, Bloem BR. Nordic walking improves mobility in Parkinson's disease. Mov Disord. 2008 Nov 15;23(15):2239-43. doi: 10.1002/mds.22293.</citation>
      <PMID>18816697</PMID>
    </reference>
    <reference>
      <citation>Reuter I, Mehnert S, Leone P, Kaps M, Oechsner M, Engelhardt M. Effects of a flexibility and relaxation programme, walking, and nordic walking on Parkinson's disease. J Aging Res. 2011;2011:232473. doi: 10.4061/2011/232473. Epub 2011 Mar 30.</citation>
      <PMID>21603199</PMID>
    </reference>
    <reference>
      <citation>Ossowski ZM, Skrobot W, Aschenbrenner P, Cesnaitiene VJ, Smaruj M. Effects of short-term Nordic walking training on sarcopenia-related parameters in women with low bone mass: a preliminary study. Clin Interv Aging. 2016 Nov 30;11:1763-1771. doi: 10.2147/CIA.S118995. eCollection 2016.</citation>
      <PMID>27942207</PMID>
    </reference>
    <reference>
      <citation>Morso L, Hartvigsen J, Puggaard L, Manniche C. Nordic walking and chronic low back pain: design of a randomized clinical trial. BMC Musculoskelet Disord. 2006 Oct 2;7:77. doi: 10.1186/1471-2474-7-77.</citation>
      <PMID>17014731</PMID>
    </reference>
    <reference>
      <citation>Sanchez-Lastra MA, Torres J, Martinez-Lemos I, Ayan C. Nordic walking for women with breast cancer: A systematic review. Eur J Cancer Care (Engl). 2019 Nov;28(6):e13130. doi: 10.1111/ecc.13130. Epub 2019 Aug 6.</citation>
      <PMID>31389108</PMID>
    </reference>
    <reference>
      <citation>Gomenuka NA, Oliveira HB, Silva ES, Costa RR, Kanitz AC, Liedtke GV, Schuch FB, Peyre-Tartaruga LA. Effects of Nordic walking training on quality of life, balance and functional mobility in elderly: A randomized clinical trial. PLoS One. 2019 Jan 30;14(1):e0211472. doi: 10.1371/journal.pone.0211472. eCollection 2019.</citation>
      <PMID>30699211</PMID>
    </reference>
    <reference>
      <citation>Mannerkorpi K, Nordeman L, Cider A, Jonsson G. Does moderate-to-high intensity Nordic walking improve functional capacity and pain in fibromyalgia? A prospective randomized controlled trial. Arthritis Res Ther. 2010;12(5):R189. doi: 10.1186/ar3159. Epub 2010 Oct 13.</citation>
      <PMID>20942911</PMID>
    </reference>
    <reference>
      <citation>Suija K, Pechter U, Kalda R, Tahepold H, Maaroos J, Maaroos HI. Physical activity of depressed patients and their motivation to exercise: Nordic Walking in family practice. Int J Rehabil Res. 2009 Jun;32(2):132-8. doi: 10.1097/MRR.0b013e32831e44ef.</citation>
      <PMID>19065108</PMID>
    </reference>
    <reference>
      <citation>Ossowski Z, Prusik K, Prusik K, Kortas J, Wiech M. Nordic walking training and physical fitness in elderly women. Polish Journal of Sport and Tourism. 2015;21(4):253-257.</citation>
    </reference>
    <reference>
      <citation>Parkatti T, Perttunen J, Wacker P. Improvements in functional capacity from Nordic walking: a randomized-controlled trial among elderly people. J Aging Phys Act. 2012 Jan;20(1):93-105. doi: 10.1123/japa.20.1.93. Epub 2011 Sep 15.</citation>
      <PMID>21949243</PMID>
    </reference>
    <reference>
      <citation>Šokelienė V, Česnaitienė VJ. The influence of nordic walking on physical fitness of elderly people. Baltic Journal of Sport and Health Sciences. 2011;3(82).</citation>
    </reference>
    <reference>
      <citation>Ben Mansour K, Gorce P, Rezzoug N. The impact of Nordic walking training on the gait of the elderly. J Sports Sci. 2018 Oct;36(20):2368-2374. doi: 10.1080/02640414.2018.1458396. Epub 2018 Mar 27.</citation>
      <PMID>29582714</PMID>
    </reference>
    <reference>
      <citation>Gomenuka NA, Oliveira HB, da Silva ES, Passos-Monteiro E, da Rosa RG, Carvalho AR, Costa RR, Rodriguez Paz MC, Pellegrini B, Peyre-Tartaruga LA. Nordic walking training in elderly, a randomized clinical trial. Part II: Biomechanical and metabolic adaptations. Sports Med Open. 2020 Jan 13;6(1):3. doi: 10.1186/s40798-019-0228-6.</citation>
      <PMID>31932999</PMID>
    </reference>
    <reference>
      <citation>Lee HS, Park JH. Effects of Nordic walking on physical functions and depression in frail people aged 70 years and above. J Phys Ther Sci. 2015 Aug;27(8):2453-6. doi: 10.1589/jpts.27.2453. Epub 2015 Aug 21.</citation>
      <PMID>26357424</PMID>
    </reference>
    <reference>
      <citation>Gmiat A, Jaworska J, Micielska K, Kortas J, Prusik K, Prusik K, Lipowski M, Radulska A, Szupryczynska N, Antosiewicz J, Ziemann E. Improvement of cognitive functions in response to a regular Nordic walking training in elderly women - A change dependent on the training experience. Exp Gerontol. 2018 Apr;104:105-112. doi: 10.1016/j.exger.2018.02.006. Epub 2018 Feb 9.</citation>
      <PMID>29432893</PMID>
    </reference>
    <reference>
      <citation>Chalmers I, Glasziou P. Avoidable waste in the production and reporting of research evidence. Lancet. 2009 Jul 4;374(9683):86-9. doi: 10.1016/S0140-6736(09)60329-9. Epub 2009 Jun 12. No abstract available.</citation>
      <PMID>19525005</PMID>
    </reference>
    <reference>
      <citation>Meisner BA, Boscart V, Gaudreau P, Stolee P, Ebert P, Heyer M, Kadowaki L, Kelly C, Levasseur M, Massie AS, Menec V, Middleton L, Sheiban Taucar L, Thornton WL, Tong C, van den Hoonaard DK, Wilson K. Interdisciplinary and Collaborative Approaches Needed to Determine Impact of COVID-19 on Older Adults and Aging: CAG/ACG and CJA/RCV Joint Statement. Can J Aging. 2020 Sep;39(3):333-343. doi: 10.1017/S0714980820000203. Epub 2020 Jun 10.</citation>
      <PMID>32408910</PMID>
    </reference>
    <reference>
      <citation>Schrack JA, Wanigatunga AA, Juraschek SP. After the COVID-19 Pandemic: The Next Wave of Health Challenges for Older Adults. J Gerontol A Biol Sci Med Sci. 2020 Sep 16;75(9):e121-e122. doi: 10.1093/gerona/glaa102. No abstract available.</citation>
      <PMID>32315025</PMID>
    </reference>
    <reference>
      <citation>Cunningham C, O' Sullivan R, Caserotti P, Tully MA. Consequences of physical inactivity in older adults: A systematic review of reviews and meta-analyses. Scand J Med Sci Sports. 2020 May;30(5):816-827. doi: 10.1111/sms.13616. Epub 2020 Feb 4.</citation>
      <PMID>32020713</PMID>
    </reference>
    <reference>
      <citation>Santini ZI, Jose PE, York Cornwell E, Koyanagi A, Nielsen L, Hinrichsen C, Meilstrup C, Madsen KR, Koushede V. Social disconnectedness, perceived isolation, and symptoms of depression and anxiety among older Americans (NSHAP): a longitudinal mediation analysis. Lancet Public Health. 2020 Jan;5(1):e62-e70. doi: 10.1016/S2468-2667(19)30230-0.</citation>
      <PMID>31910981</PMID>
    </reference>
    <reference>
      <citation>Queens Gazette. How the School of Rehabilitation Therapy is breaking down barriers to physiotherapy in the Kingston community. In. Kingston, Ontraio, Canada 2021:https://healthsci.queensu.ca/stories/feature/how-school-rehabilitation-therapy-breaking-down barriers-physiotherapy-kingston.</citation>
    </reference>
    <reference>
      <citation>Steffen TM, Hacker TA, Mollinger L. Age- and gender-related test performance in community-dwelling elderly people: Six-Minute Walk Test, Berg Balance Scale, Timed Up &amp; Go Test, and gait speeds. Phys Ther. 2002 Feb;82(2):128-37. doi: 10.1093/ptj/82.2.128.</citation>
      <PMID>11856064</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>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 15, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Queen's University</investigator_affiliation>
      <investigator_full_name>Dr. Mohammad Auais, PhD</investigator_full_name>
      <investigator_title>Assistant Professor, School Of Rehabilitation Therapy</investigator_title>
    </responsible_party>
    <keyword>Fear of Falling</keyword>
    <keyword>Nordic Walking</keyword>
    <keyword>Older adults</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05965011
  org study id: 6030812
  nct id: NCT05965011
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This is a pilot study that aims to test the feasibility and safety of a novel Nordic Walking
        (NW) activity program for community-dwelling older adults who are at risk of falling or
        experience fear of falling (FOF). The study also aims to determine the distribution and
        effect sizes of outcomes to inform future sample size calculations and explore participants'
        perspectives of the intervention.
  
        Participants will be asked to:
  
          -  Attend training sessions to learn proper Nordic Walking techniques.
  
          -  Engage in supervised Nordic Walking sessions for a specified duration and frequency.
  
          -  Keep a log of their walking activities and any falls or near falls experienced.
  
          -  Complete questionnaires to assess their fear of falling and overall physical activity
             levels.
  
        If there is a comparison group:
  
        Researchers will compare the intervention group, consisting of older adults participating in
        the Nordic Walking program, with a control group of older adults who do not receive the
        intervention. The comparison will be made to determine if Nordic Walking has a significant
        impact on reducing falls and fear of falling compared to the control group.
  Introduction:
  
        this is a pilot study that aims to test the feasibility and safety of a novel Nordic Walking
        (NW) activity program for community-dwelling older adults who are at risk of falling or
        experience fear of falling (FOF). The study also aims to determine the distribution and
        effect sizes of outcomes to inform future sample size calculations and explore participants'
        perspectives of the intervention.
  
        Background:
  
        Falls and fear of falling are significant concerns among older adults, leading to physical
        impairments, psychological trauma, and a decline in abilities and quality of life. Exercise
        has been shown to be effective in improving muscle strength, balance, mobility, and postural
        control, all of which are risk factors for falls and FOF. However, traditional exercise
        programs have limitations in terms of cost, sustainability, and long-term adherence. Nordic
        Walking, a low-risk and low-tech intervention, has emerged as a promising alternative,
        offering numerous physical and mental health benefits.
  
        Study Design:
  
        The study will be conducted in two stages. Stage One will involve a two-arm, parallel,
        single-blind, randomized controlled pilot trial. Forty older adults at risk of falling will
        be recruited and randomly assigned to either a 10-week NW intervention group or a control
        group. The intervention group will receive supervised NW training sessions and will be
        coached to practice independently. The control group will receive regular phone calls to
        discuss healthy lifestyle habits.
  
        Outcome Measures:
  
        The study will collect feasibility and safety data, including recruitment, adherence, and
        follow-up rates, as well as adverse events. Effectiveness outcomes will be assessed using
        measures such as the Timed Up and Go (TUG) test, Stay Independent Falls Risk Assessment Tool,
        Falls Efficacy Scale-International (FES-I), Activities-Specific Balance Confidence Scale, and
        the Four-Square Step Test (FSST).
  
        Data Analysis:
  
        Descriptive statistics will be used to characterize participants and feasibility measures.
        Hedge's effect size and confidence intervals will be calculated. Independent samples t-tests
        and chi-square tests will be used to compare the intervention and control groups. The main
        focus of the analysis will be to estimate the effect size, test the intervention's
        feasibility and safety, and inform future studies.
  
        Sample Size:
  
        The study aims to recruit 40 participants (20 per group) to ensure study robustness and
        account for potential dropouts.
  
        Stage Two:
  
        In the second stage, qualitative interviews will be conducted with all participants in the
        intervention group to gather feedback on the acceptability, perceived value, barriers, and
        facilitators of participating. The data will be analyzed using interpretive description to
        identify themes and categories.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This study will be a pilot trial conducted as a two-arm, parallel, single-blind, randomized controlled trial.
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  masking description: The single-blind design will involve that the assessors are unaware of the group assignments.
  measure: Estimate the effect size of intervention (Cohen's D)
  time frame: Through study completion, an average of 1.5 years
  description: Effect size estimation is vital in assessing the impact of interventions like Nordic walking and planning future studies. It involves quantifying the magnitude of the intervention's effect on the outcome variable.
  measure: Evaluate the adherence rate to the intervention (as a measure of feasibility)
  time frame: Through study completion, an average of 1.5 years
  description: Participant Adherence to the Intervention: This measure examines the extent to which participants adhere to the prescribed Nordic walking program. It involves tracking the frequency, duration, and intensity of Nordic walking sessions completed by participants. Adherence rates can be calculated based on the number of sessions attended or completed as planned.
  measure: Assess safety of the intervention
  time frame: Through study completion, an average of 1.5 years
  description: Monitoring Adverse Events: We systematically record and monitor any adverse events or incidents during the study. This includes injuries, discomfort, or any negative effects reported by participants.
  measure: Timed Up and Go (TUG) to assess fall risk
  time frame: Pre (week 0) /post intervention (week 11)
  description: The Timed Up and Go (TUG) test is a widely used clinical assessment tool to evaluate mobility and functional mobility, specifically in older adults. While it is not specifically designed to determine the risk of falling, it can provide valuable information that is correlated with fall risk. The TUG test measures the time it takes for an individual to stand up from a chair, walk a set distance (typically 3 meters), turn around, return to the chair, and sit down again.
  measure: Fear of Falling: Fear of falling will be measured by the Falls Efficacy Scale-International (FES-I)
  time frame: Pre (week 0) /post intervention (week 11)
  description: Scale: Falls Efficacy Scale-International (FES-I) Minimum Value: 0 (not at all confident) Maximum Value: 100 (completely confident) Interpretation: In the FES-I, higher scores indicate greater fear of falling. Therefore, a higher score on the FES-I reflects a worse outcome, indicating a higher level of fear and reduced confidence in performing daily activities without falling. Conversely, a lower score on the FES-I suggests a better outcome, indicating a lower level of fear and greater confidence in performing activities without fear of falling.
  measure: Performance on the Four-Square Step Test (FSST) will be measured to assess balance.
  time frame: Pre (week 0) /post intervention (week 11)
  description: The Four-Square Step Test (FSST) does not yield a specific score on a scale like some other assessments. Instead, the FSST primarily focuses on the time taken to complete the test and the occurrence of errors or missteps.
  When assessing FSST performance, the following information is typically recorded:
  Completion Time: The time the individual takes to complete the FSST is measured in seconds. A shorter completion time generally indicates better balance and agility.
  Errors or Missteps: The number of errors or missteps made by the individual during the FSST is recorded. Errors can include stepping outside the designated squares, incorrect foot placement, or loss of balance. Fewer errors suggest better balance control and coordination.
  arm group label: Intervention (Nordic walking)
  arm group type: Experimental
  description: Nordic walking training. These coaching principles will focus on highlighting the participants' strengths and resourcefulness, setting goals, and utilizing solution-focused problem-solving techniques to achieve those goals during practice and related activities . This group sessions will be conducted biweekly to ensure appropriate progression and adherence to the guidelines set by the International Nordic Walking Federation.
  In addition to the supervised group sessions, participants will also receive supervised NW training from a certified NW instructor. Participants will be encouraged to set goals and develop strategies to facilitate independent practice for at least three 30-minute sessions per week over a period of 10 weeks. These unsupervised sessions aim to encourage participants to engage in regular practice outside of the group sessions.
  arm group label: Control (phone calls)
  arm group type: No Intervention
  description: The control group will receive regular contact to control for attention and maintain participant engagement throughout the study. Over the course of the 10 weeks, participants in this group will receive 5 biweekly phone calls from the study's graduate research assistant (RA).
  During each phone call, the RA will engage in discussions with participants about leading a healthy lifestyle in general, covering topics such as proper nutrition and adequate sleep. Additionally, the RA will gather safety-related data, including information on any falls that may have occurred. The phone calls will also serve as reminders for participants about upcoming assessments and their importance in the study. The investigators will provide a training session to the control group following the completion of the study if they are interested.
  intervention type: Other
  intervention name: Exercise training
  description: The intervention will be a combination of both supervised and unsupervised sessions. Participants in the Nordic Walking (NW) treatment group will attend 5 one-hour group sessions, which will incorporate coaching principles.
  arm group label: Intervention (Nordic walking)
  other name: Nordic walking
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Mohammad Auais, BSc PT, MSc PT, PhD
  phone: 613-533-3112
  phone ext: 33112
  email: mohammad.auais@queensu.ca
  facility: 
  status: Recruiting
  contact: 
  country: Canada
  citation: Hughes VA, Frontera WR, Wood M, Evans WJ, Dallal GE, Roubenoff R, Fiatarone Singh MA. Longitudinal muscle strength changes in older adults: influence of muscle mass, physical activity, and health. J Gerontol A Biol Sci Med Sci. 2001 May;56(5):B209-17. doi: 10.1093/gerona/56.5.b209.
  PMID: 11320101
  citation: Krasovsky T, Banina MC, Hacmon R, Feldman AG, Lamontagne A, Levin MF. Stability of gait and interlimb coordination in older adults. J Neurophysiol. 2012 May;107(9):2560-9. doi: 10.1152/jn.00950.2011. Epub 2012 Feb 1.
  PMID: 22298827
  citation: Herman T, Giladi N, Gurevich T, Hausdorff JM. Gait instability and fractal dynamics of older adults with a "cautious" gait: why do certain older adults walk fearfully? Gait Posture. 2005 Feb;21(2):178-85. doi: 10.1016/j.gaitpost.2004.01.014.
  PMID: 15639397
  citation: Beauchet O, Annweiler C, Allali G, Berrut G, Herrmann FR, Dubost V. Recurrent falls and dual task-related decrease in walking speed: is there a relationship? J Am Geriatr Soc. 2008 Jul;56(7):1265-9. doi: 10.1111/j.1532-5415.2008.01766.x. Epub 2008 May 26.
  PMID: 18510582
  citation: Bertera EM, Bertera RL. Fear of falling and activity avoidance in a national sample of older adults in the United States. Health Soc Work. 2008 Feb;33(1):54-62. doi: 10.1093/hsw/33.1.54.
  PMID: 18326450
  citation: Keast M-L. Nordic walking: introducing a new low-impact exercise system for cardiac rehabilitation patients. Minto prevention and rehabilitation center, University of Ottawa Heart Institute. 2009:13- 14.
  citation: Ossowski Z, Wawryniku M, Česnaitiene V. Influence of nordic walking training on static and dynamic body balance among the elderly. Baltic Journal of Health and Physical Activity. 2015;7(1):72-80.
  citation: Karawan A, Porcari J, Butta H, Postmus A, Stoughton L, Larkin J. Effects of 12 weeks of walking or exerstriding on upper body strength and endurance. Medicine & Science in Sports & Exercise. 1992;24(5):S138.
  citation: Kortas J, Kuchta A, Prusik K, Prusik K, Ziemann E, Labudda S, Cwiklinska A, Wieczorek E, Jankowski M, Antosiewicz J. Nordic walking training attenuation of oxidative stress in association with a drop in body iron stores in elderly women. Biogerontology. 2017 Aug;18(4):517-524. doi: 10.1007/s10522-017-9681-0. Epub 2017 Feb 22.
  PMID: 28229255
  citation: Dalton C, Nantel J. Nordic Walking Improves Postural Alignment and Leads to a More Normal Gait Pattern Following Weeks of Training: A Pilot Study. J Aging Phys Act. 2016 Oct;24(4):575-582. doi: 10.1123/japa.2015-0204. Epub 2016 Aug 24.
  PMID: 27051072
  citation: Willson J, Torry MR, Decker MJ, Kernozek T, Steadman JR. Effects of walking poles on lower extremity gait mechanics. Med Sci Sports Exerc. 2001 Jan;33(1):142-7. doi: 10.1097/00005768-200101000-00021.
  PMID: 11194099
  citation: Reelick MF, van Iersel MB, Kessels RP, Rikkert MG. The influence of fear of falling on gait and balance in older people. Age Ageing. 2009 Jul;38(4):435-40. doi: 10.1093/ageing/afp066. Epub 2009 May 18.
  PMID: 19451658
  citation: Rubenstein LZ, Vivrette R, Harker JO, Stevens JA, Kramer BJ. Validating an evidence-based, self-rated fall risk questionnaire (FRQ) for older adults. J Safety Res. 2011 Dec;42(6):493-9. doi: 10.1016/j.jsr.2011.08.006. Epub 2011 Nov 17.
  PMID: 22152267
  citation: Stevens JA. The STEADI Tool Kit: A Fall Prevention Resource for Health Care Providers. IHS Prim Care Provid. 2013 Sep;39(9):162-166. No abstract available.
  PMID: 26766893
  citation: van Zyl LE, Roll LC, Stander MW, Richter S. Positive Psychological Coaching Definitions and Models: A Systematic Literature Review. Front Psychol. 2020 May 6;11:793. doi: 10.3389/fpsyg.2020.00793. eCollection 2020.
  PMID: 32435218
  citation: International Nordic Walking Federation. http://inwa-nordicwalking.com/. Accessed May 2021.
  citation: Bullo V, Gobbo S, Vendramin B, Duregon F, Cugusi L, Di Blasio A, Bocalini DS, Zaccaria M, Bergamin M, Ermolao A. Nordic Walking Can Be Incorporated in the Exercise Prescription to Increase Aerobic Capacity, Strength, and Quality of Life for Elderly: A Systematic Review and Meta-Analysis. Rejuvenation Res. 2018 Apr;21(2):141-161. doi: 10.1089/rej.2017.1921. Epub 2017 Nov 20.
  PMID: 28756746
  citation: Shumway-Cook A, Brauer S, Woollacott M. Predicting the probability for falls in community-dwelling older adults using the Timed Up & Go Test. Phys Ther. 2000 Sep;80(9):896-903.
  PMID: 10960937
  citation: Delbaere K, Close JC, Mikolaizak AS, Sachdev PS, Brodaty H, Lord SR. The Falls Efficacy Scale International (FES-I). A comprehensive longitudinal validation study. Age Ageing. 2010 Mar;39(2):210-6. doi: 10.1093/ageing/afp225. Epub 2010 Jan 8.
  PMID: 20061508
  citation: Powell LE, Myers AM. The Activities-specific Balance Confidence (ABC) Scale. J Gerontol A Biol Sci Med Sci. 1995 Jan;50A(1):M28-34. doi: 10.1093/gerona/50a.1.m28.
  PMID: 7814786
  citation: Dite W, Temple VA. A clinical test of stepping and change of direction to identify multiple falling older adults. Arch Phys Med Rehabil. 2002 Nov;83(11):1566-71. doi: 10.1053/apmr.2002.35469.
  PMID: 12422327
  citation: Sullivan GM, Feinn R. Using Effect Size-or Why the P Value Is Not Enough. J Grad Med Educ. 2012 Sep;4(3):279-82. doi: 10.4300/JGME-D-12-00156.1. No abstract available.
  PMID: 23997866
  citation: Mangione KK, Craik RL, Palombaro KM, Tomlinson SS, Hofmann MT. Home-based leg-strengthening exercise improves function 1 year after hip fracture: a randomized controlled study. J Am Geriatr Soc. 2010 Oct;58(10):1911-7. doi: 10.1111/j.1532-5415.2010.03076.x.
  PMID: 20929467
  citation: Moore CG, Carter RE, Nietert PJ, Stewart PW. Recommendations for planning pilot studies in clinical and translational research. Clin Transl Sci. 2011 Oct;4(5):332-7. doi: 10.1111/j.1752-8062.2011.00347.x.
  PMID: 22029804
  citation: Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics: The Journal of Applied Statistics in the Pharmaceutical Industry. 2005;4(4):287-291.
  citation: Thorne S, Kirkham SR, MacDonald-Emes J. Interpretive description: a noncategorical qualitative alternative for developing nursing knowledge. Res Nurs Health. 1997 Apr;20(2):169-77. doi: 10.1002/(sici)1098-240x(199704)20:23.0.co;2-i.
  PMID: 9100747
  citation: Soriano TA, DeCherrie LV, Thomas DC. Falls in the community-dwelling older adult: a review for primary-care providers. Clin Interv Aging. 2007;2(4):545-54. doi: 10.2147/cia.s1080.
  PMID: 18225454
  citation: Parachute. Fall prevention. 2014. https://parachute.ca/en/injury-topic/fall-prevention-for-seniors/. Accessed Mar 2021
  citation: Falls: Assessment and Prevention of Falls in Older People. London: National Institute for Health and Care Excellence (NICE); 2013 Jun. Available from http://www.ncbi.nlm.nih.gov/books/NBK258885/
  PMID: 25506960
  citation: Tinetti ME, Powell L. Fear of falling and low self-efficacy: a case of dependence in elderly persons. J Gerontol. 1993 Sep;48 Spec No:35-8. doi: 10.1093/geronj/48.special_issue.35. No abstract available.
  PMID: 8409238
  citation: Mane AB, Sanjana T, Patil PR, Sriniwas T. Prevalence and correlates of fear of falling among elderly population in urban area of Karnataka, India. J Midlife Health. 2014 Jul;5(3):150-5. doi: 10.4103/0976-7800.141224.
  PMID: 25317002
  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
  citation: Murphy SL, Dubin JA, Gill TM. The development of fear of falling among community-living older women: predisposing factors and subsequent fall events. J Gerontol A Biol Sci Med Sci. 2003 Oct;58(10):M943-7. doi: 10.1093/gerona/58.10.m943.
  PMID: 14570863
  citation: Auais M, French S, Alvarado B, Pirkle C, Belanger E, Guralnik J. Fear of Falling Predicts Incidence of Functional Disability 2 Years Later: A Perspective From an International Cohort Study. J Gerontol A Biol Sci Med Sci. 2018 Aug 10;73(9):1212-1215. doi: 10.1093/gerona/glx237.
  PMID: 29220420
  citation: Parker SG, Corner L, Laing K, Nestor G, Craig D, Collerton J, Frith J, Roberts HC, Sayer AA, Allan LM, Robinson L, Cowan K; multiple conditions in later life priority setting partnership. Priorities for research in multiple conditions in later life (multi-morbidity): findings from a James Lind Alliance Priority Setting Partnership. Age Ageing. 2019 May 1;48(3):401-406. doi: 10.1093/ageing/afz014.
  PMID: 30892604
  citation: Rimer J, Dwan K, Lawlor DA, Greig CA, McMurdo M, Morley W, Mead GE. Exercise for depression. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD004366. doi: 10.1002/14651858.CD004366.pub5.
  PMID: 22786489
  citation: Bula CJ, Monod S, Hoskovec C, Rochat S. Interventions aiming at balance confidence improvement in older adults: an updated review. Gerontology. 2011;57(3):276-86. doi: 10.1159/000322241. Epub 2010 Oct 29.
  PMID: 21042008
  citation: Howe TE, Rochester L, Neil F, Skelton DA, Ballinger C. Exercise for improving balance in older people. Cochrane Database Syst Rev. 2011 Nov 9;(11):CD004963. doi: 10.1002/14651858.CD004963.pub3.
  PMID: 22071817
  citation: Huang TT, Yang LH, Liu CY. Reducing the fear of falling among community-dwelling elderly adults through cognitive-behavioural strategies and intense Tai Chi exercise: a randomized controlled trial. J Adv Nurs. 2011 May;67(5):961-71. doi: 10.1111/j.1365-2648.2010.05553.x. Epub 2011 Jan 7.
  PMID: 21214623
  citation: Watzek D, Mischler E, Sonam D, et al. Effectiveness and economic evaluation of therapeutic nordic walking in patients with psychosomatic disorders: A pragmatic randomized controlled trial. Psychology. 2016;6(11):665-675.
  citation: Finnegan S, Bruce J, Skelton DA, Withers EJ, Lamb SE; PreFIT Study Group. Development and delivery of an exercise programme for falls prevention: the Prevention of Falls Injury Trial (PreFIT). Physiotherapy. 2018 Mar;104(1):72-79. doi: 10.1016/j.physio.2017.06.004. Epub 2017 Jun 27.
  PMID: 28801033
  citation: Thompson PD, Arena R, Riebe D, Pescatello LS; American College of Sports Medicine. ACSM's new preparticipation health screening recommendations from ACSM's guidelines for exercise testing and prescription, ninth edition. Curr Sports Med Rep. 2013 Jul-Aug;12(4):215-7. doi: 10.1249/JSR.0b013e31829a68cf. No abstract available.
  PMID: 23851406
  citation: Yamauchi T, Islam MM, Koizumi D, Rogers ME, Rogers NL, Takeshima N. Effect of home-based well-rounded exercise in community-dwelling older adults. J Sports Sci Med. 2005 Dec 1;4(4):563-71. eCollection 2005 Dec.
  PMID: 24501569
  citation: Dishman RK. Increasing and maintaining exercise and physical activity. Behavior Therapy. 1991;22(3):345-378. 10
  citation: Cyarto EV, Brown WJ, Marshall AL. Retention, adherence and compliance: important considerations for home- and group-based resistance training programs for older adults. J Sci Med Sport. 2006 Oct;9(5):402-12. doi: 10.1016/j.jsams.2006.06.020. Epub 2006 Sep 5.
  PMID: 16911871
  citation: Yan T, Wilber KH, Simmons WJ. Motivating high-risk older adults to exercise: does coaching matter? Home Health Care Serv Q. 2011 Apr;30(2):84-95. doi: 10.1080/01621424.2011.569670.
  PMID: 21590567
  citation: Church TS, Earnest CP, Morss GM. Field testing of physiological responses associated with Nordic Walking. Res Q Exerc Sport. 2002 Sep;73(3):296-300. doi: 10.1080/02701367.2002.10609023.
  PMID: 12230336
  citation: Jordan AN, Olson TP, Earnest CP, Morss GM, Church TS. Metabolic cost of high intensity poling while nordic walking versus normal walking. Medicine & Science in Sports & Exercise. 2001;33(5):S86.
  citation: Figard-Fabre H, Fabre N, Leonardi A, Schena F. Physiological and perceptual responses to Nordic walking in obese middle-aged women in comparison with the normal walk. Eur J Appl Physiol. 2010 Apr;108(6):1141-51. doi: 10.1007/s00421-009-1315-z. Epub 2009 Dec 20.
  PMID: 20091181
  citation: Mikalacki M, Cokorilo N, Katic R. Effect of nordic walking on functional ability and blood pressure in elderly women. Coll Antropol. 2011 Sep;35(3):889-94.
  PMID: 22053573
  citation: Bulinska K, Kropielnicka K, Jasinski T, Wojcieszczyk-Latos J, Pilch U, Dabrowska G, Skorkowska-Telichowska K, Kalka D, Zywar K, Paszkowski R, Wozniewski M, Szuba A, Jasinski R. Nordic pole walking improves walking capacity in patients with intermittent claudication: a randomized controlled trial. Disabil Rehabil. 2016;38(13):1318-24. doi: 10.3109/09638288.2015.1077398. Epub 2015 Aug 25.
  PMID: 26305413
  citation: Breyer MK, Breyer-Kohansal R, Funk GC, Dornhofer N, Spruit MA, Wouters EF, Burghuber OC, Hartl S. Nordic walking improves daily physical activities in COPD: a randomised controlled trial. Respir Res. 2010 Aug 22;11(1):112. doi: 10.1186/1465-9921-11-112.
  PMID: 20727209
  citation: van Eijkeren FJ, Reijmers RS, Kleinveld MJ, Minten A, Bruggen JP, Bloem BR. Nordic walking improves mobility in Parkinson's disease. Mov Disord. 2008 Nov 15;23(15):2239-43. doi: 10.1002/mds.22293.
  PMID: 18816697
  citation: Reuter I, Mehnert S, Leone P, Kaps M, Oechsner M, Engelhardt M. Effects of a flexibility and relaxation programme, walking, and nordic walking on Parkinson's disease. J Aging Res. 2011;2011:232473. doi: 10.4061/2011/232473. Epub 2011 Mar 30.
  PMID: 21603199
  citation: Ossowski ZM, Skrobot W, Aschenbrenner P, Cesnaitiene VJ, Smaruj M. Effects of short-term Nordic walking training on sarcopenia-related parameters in women with low bone mass: a preliminary study. Clin Interv Aging. 2016 Nov 30;11:1763-1771. doi: 10.2147/CIA.S118995. eCollection 2016.
  PMID: 27942207
  citation: Morso L, Hartvigsen J, Puggaard L, Manniche C. Nordic walking and chronic low back pain: design of a randomized clinical trial. BMC Musculoskelet Disord. 2006 Oct 2;7:77. doi: 10.1186/1471-2474-7-77.
  PMID: 17014731
  citation: Sanchez-Lastra MA, Torres J, Martinez-Lemos I, Ayan C. Nordic walking for women with breast cancer: A systematic review. Eur J Cancer Care (Engl). 2019 Nov;28(6):e13130. doi: 10.1111/ecc.13130. Epub 2019 Aug 6.
  PMID: 31389108
  citation: Gomenuka NA, Oliveira HB, Silva ES, Costa RR, Kanitz AC, Liedtke GV, Schuch FB, Peyre-Tartaruga LA. Effects of Nordic walking training on quality of life, balance and functional mobility in elderly: A randomized clinical trial. PLoS One. 2019 Jan 30;14(1):e0211472. doi: 10.1371/journal.pone.0211472. eCollection 2019.
  PMID: 30699211
  citation: Mannerkorpi K, Nordeman L, Cider A, Jonsson G. Does moderate-to-high intensity Nordic walking improve functional capacity and pain in fibromyalgia? A prospective randomized controlled trial. Arthritis Res Ther. 2010;12(5):R189. doi: 10.1186/ar3159. Epub 2010 Oct 13.
  PMID: 20942911
  citation: Suija K, Pechter U, Kalda R, Tahepold H, Maaroos J, Maaroos HI. Physical activity of depressed patients and their motivation to exercise: Nordic Walking in family practice. Int J Rehabil Res. 2009 Jun;32(2):132-8. doi: 10.1097/MRR.0b013e32831e44ef.
  PMID: 19065108
  citation: Ossowski Z, Prusik K, Prusik K, Kortas J, Wiech M. Nordic walking training and physical fitness in elderly women. Polish Journal of Sport and Tourism. 2015;21(4):253-257.
  citation: Parkatti T, Perttunen J, Wacker P. Improvements in functional capacity from Nordic walking: a randomized-controlled trial among elderly people. J Aging Phys Act. 2012 Jan;20(1):93-105. doi: 10.1123/japa.20.1.93. Epub 2011 Sep 15.
  PMID: 21949243
  citation: Šokelienė V, Česnaitienė VJ. The influence of nordic walking on physical fitness of elderly people. Baltic Journal of Sport and Health Sciences. 2011;3(82).
  citation: Ben Mansour K, Gorce P, Rezzoug N. The impact of Nordic walking training on the gait of the elderly. J Sports Sci. 2018 Oct;36(20):2368-2374. doi: 10.1080/02640414.2018.1458396. Epub 2018 Mar 27.
  PMID: 29582714
  citation: Gomenuka NA, Oliveira HB, da Silva ES, Passos-Monteiro E, da Rosa RG, Carvalho AR, Costa RR, Rodriguez Paz MC, Pellegrini B, Peyre-Tartaruga LA. Nordic walking training in elderly, a randomized clinical trial. Part II: Biomechanical and metabolic adaptations. Sports Med Open. 2020 Jan 13;6(1):3. doi: 10.1186/s40798-019-0228-6.
  PMID: 31932999
  citation: Lee HS, Park JH. Effects of Nordic walking on physical functions and depression in frail people aged 70 years and above. J Phys Ther Sci. 2015 Aug;27(8):2453-6. doi: 10.1589/jpts.27.2453. Epub 2015 Aug 21.
  PMID: 26357424
  citation: Gmiat A, Jaworska J, Micielska K, Kortas J, Prusik K, Prusik K, Lipowski M, Radulska A, Szupryczynska N, Antosiewicz J, Ziemann E. Improvement of cognitive functions in response to a regular Nordic walking training in elderly women - A change dependent on the training experience. Exp Gerontol. 2018 Apr;104:105-112. doi: 10.1016/j.exger.2018.02.006. Epub 2018 Feb 9.
  PMID: 29432893
  citation: Chalmers I, Glasziou P. Avoidable waste in the production and reporting of research evidence. Lancet. 2009 Jul 4;374(9683):86-9. doi: 10.1016/S0140-6736(09)60329-9. Epub 2009 Jun 12. No abstract available.
  PMID: 19525005
  citation: Meisner BA, Boscart V, Gaudreau P, Stolee P, Ebert P, Heyer M, Kadowaki L, Kelly C, Levasseur M, Massie AS, Menec V, Middleton L, Sheiban Taucar L, Thornton WL, Tong C, van den Hoonaard DK, Wilson K. Interdisciplinary and Collaborative Approaches Needed to Determine Impact of COVID-19 on Older Adults and Aging: CAG/ACG and CJA/RCV Joint Statement. Can J Aging. 2020 Sep;39(3):333-343. doi: 10.1017/S0714980820000203. Epub 2020 Jun 10.
  PMID: 32408910
  citation: Schrack JA, Wanigatunga AA, Juraschek SP. After the COVID-19 Pandemic: The Next Wave of Health Challenges for Older Adults. J Gerontol A Biol Sci Med Sci. 2020 Sep 16;75(9):e121-e122. doi: 10.1093/gerona/glaa102. No abstract available.
  PMID: 32315025
  citation: Cunningham C, O' Sullivan R, Caserotti P, Tully MA. Consequences of physical inactivity in older adults: A systematic review of reviews and meta-analyses. Scand J Med Sci Sports. 2020 May;30(5):816-827. doi: 10.1111/sms.13616. Epub 2020 Feb 4.
  PMID: 32020713
  citation: Santini ZI, Jose PE, York Cornwell E, Koyanagi A, Nielsen L, Hinrichsen C, Meilstrup C, Madsen KR, Koushede V. Social disconnectedness, perceived isolation, and symptoms of depression and anxiety among older Americans (NSHAP): a longitudinal mediation analysis. Lancet Public Health. 2020 Jan;5(1):e62-e70. doi: 10.1016/S2468-2667(19)30230-0.
  PMID: 31910981
  citation: Queens Gazette. How the School of Rehabilitation Therapy is breaking down barriers to physiotherapy in the Kingston community. In. Kingston, Ontraio, Canada 2021:https://healthsci.queensu.ca/stories/feature/how-school-rehabilitation-therapy-breaking-down barriers-physiotherapy-kingston.
  citation: Steffen TM, Hacker TA, Mollinger L. Age- and gender-related test performance in community-dwelling elderly people: Six-Minute Walk Test, Berg Balance Scale, Timed Up & Go Test, and gait speeds. Phys Ther. 2002 Feb;82(2):128-37. doi: 10.1093/ptj/82.2.128.
  PMID: 11856064
  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
  responsible party type: Principal Investigator
  investigator affiliation: Queen's University
  investigator full name: Dr. Mohammad Auais, PhD
  investigator title: Assistant Professor, School Of Rehabilitation Therapy
  sharing ipd: No