<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/NCT01698463</url>
  </required_header>
  <id_info>
    <org_study_id>17664</org_study_id>
    <nct_id>NCT01698463</nct_id>
  </id_info>
  <brief_title>Prescribe Exercise for Prevention of Falls and Fractures: A Family Health Team Approach</brief_title>
  <acronym>PEPTEAM</acronym>
  <official_title>Tailored Exercise for Fall and Fracture Prevention in Older Adults: A Family Health Team Approach</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Waterloo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Centre for Family Medicine, Ontario</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Waterloo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Falls and fractures are a leading cause of death and disability in the older adult&#xD;
      population. The consequences of falls and fractures contribute substantially to health care&#xD;
      costs and can have a significant negative impact on the quality of life of the individual.&#xD;
      Exercise has been studied as an option to reduce fracture risk and prevent falls though&#xD;
      improving balance and muscle strength. The prevention of falls is important, as a history of&#xD;
      falls is strongly predictive of suffering another. Those who are at a high risk of fracture&#xD;
      or falling require a patient specific assessment and individualized exercise prescription&#xD;
      that is tailored to their needs. This kind of program may not be typically available within&#xD;
      the community and at a low cost. These individuals may experience difficulty when trying to&#xD;
      engage in exercise due to barriers such as a lack of transportation, and a lack of knowledge.&#xD;
      As the first point of contact with the health care system for many family doctors are in the&#xD;
      ideal position to deliver exercise advice to their patients. However, a lack of time and&#xD;
      specialized skills in prescribing exercise make this difficult for many of them. As a result,&#xD;
      family health teams who provide interdisciplinary patient centered care are becoming popular.&#xD;
      In this model the care is shared and provided by the most appropriate team member (e.g.&#xD;
      doctor, nurse, exercise specialist). Additionally, many exercise interventions do not include&#xD;
      a behavior change aspect, which may be an important component when trying to get individuals&#xD;
      to engage in a new health behavior like exercise. Therefore the purpose of this project is to&#xD;
      assess the feasibility of implementing a tailored exercise program to those at high risk of&#xD;
      falls or fractures over the age of 65 in a primary care setting using an interdisciplinary&#xD;
      model of care that is based on a health behaviour change model.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Falls and fractures together represent one of the leading causes of morbidity and mortality&#xD;
      within the older adult population. Additionally, the consequences of falls and fractures&#xD;
      contribute substantial costs to the health care system and negatively impact the quality of&#xD;
      life of the individual. Given that Canada's aging population in increasing at an&#xD;
      unprecedented rate, it is imperative that the prevention and management of falls and&#xD;
      fractures is made a priority. One such population particularly vulnerable to falls and&#xD;
      fractures are those diagnosed with osteoporosis or low bone mass.&#xD;
&#xD;
      It has been estimated that approximately 10 billion individuals have been diagnosed with&#xD;
      osteoporosis and another 34 million are at risk with low bone mass. Osteoporosis-related&#xD;
      fragility fractures are a common consequence of osteoporosis and result in increased&#xD;
      morbidity and mortality. Approximately 50% of those who suffer a hip fracture do not regain&#xD;
      their previous level of mobility and functional independence thus resulting in many of these&#xD;
      individuals relying on the use of assistive devices.&#xD;
&#xD;
      Currently the emphasis of osteoporosis treatment and management is to prevent the occurrence&#xD;
      of fragility fractures and the subsequent side effects that accompany them. A recent&#xD;
      meta-analysis has shown that exercise can assist in the prevention and maintenance of bone&#xD;
      loss in postmenopausal women. Other benefits of exercise such as increases in muscle strength&#xD;
      and balance have been strongly established to indirectly prevent fractures through a&#xD;
      reduction in falls risk. Those who are at a high risk of falls or fracture require patient&#xD;
      specific assessment and individualized prescription that is not typically available within&#xD;
      the community or at a low cost. Further, it may be difficult to engage these individuals if&#xD;
      they have spent most of their life in a sedentary state and experience barriers such as a&#xD;
      lack of transportation, and a lack of knowledge on appropriate types of exercise or how to&#xD;
      initiate exercise into their daily living. Furthermore, many exercises may not be appropriate&#xD;
      for all individuals depending on location of fracture and level of physical function. It has&#xD;
      been emphasized that the focus should be on an individualized exercise program, which would&#xD;
      encompass individual needs while recognizing individual limitations.&#xD;
&#xD;
      Family physicians may be in an ideal position to deliver an exercise prescription to a&#xD;
      patient, as they are often the first point of contact with the health care system. However,&#xD;
      there have been a number of problems cited with using family physicians to implement the&#xD;
      delivery of an exercise prescription. Among those barriers, a lack of time and a lack of&#xD;
      knowledge have been identified as the most problematic. An interdisciplinary family health&#xD;
      team model of care is becoming increasingly important in regards to the treatment of chronic&#xD;
      conditions such as osteoporosis. Family health teams provide an ideal form of care where team&#xD;
      members work together to deliver the program and enhance adherence.&#xD;
&#xD;
      A limitation of many exercise interventions is that they fail to include a behavior change&#xD;
      component which may be an important factor to consider when attempting to facilitate&#xD;
      adherence to an exercise program. The Health Action Process Approach is a model of behavior&#xD;
      change that has been widely used in a variety of health contexts including but not limited to&#xD;
      physical activity. The rationale for the selection of this model is that it incorporates key&#xD;
      principles of other behavior change models. Furthermore, the model has been cited as being a&#xD;
      valid and reliable tool for predicting physical activity levels in older adults.&#xD;
&#xD;
      This project outlines an exercise intervention that is multidisciplinary in nature and&#xD;
      tailored to the individual to be employed within an interdisciplinary family health team.&#xD;
      Additionally, a behavior change component is built into this intervention with key principles&#xD;
      such as action planning and coping planning that are based on the HAPA model to facilitate&#xD;
      the uptake of physical activity in this vulnerable population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">July 2012</completion_date>
  <primary_completion_date type="Actual">June 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Physical Activity (Reporting Change in Physical Activity From Baseline to Six-week Follow-up)</measure>
    <time_frame>Baseline, 6 week follow-up</time_frame>
    <description>The X2-Mini accelerometer (Gulf Coast Data Concepts.,USA) is a three-dimensional sensor that is used to capture the activity levels of an individual. The accelerometer is worn on the hip of the participant for four days. The number of minutes that the individual spends in each exercise intensity category is acquired. Accelerometer thresholds make up four categories of activity: (1) sedentary; (2) low-light; (3) high-light; (4) moderate-vigorous. Activity monitors have been indicated as the most accurate means of measuring physical activity levels.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical Activity (Self-report) (Reporting Change in Physical Activity From Baseline to Six-week Follow-up)</measure>
    <time_frame>Baseline, 6 week follow-up</time_frame>
    <description>Participants complete a physical activity log book daily in order to document their completion of the prescribed exercises and list any additional activities that they may have been engaged in. The percentage of prescribed exercises completed are reported (for e.g. if participants completed 2 of 3 prescribed exercise then the reported percentage would be 67%). Mean (SD) are reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Behavior Change Outcome: Action Planning</measure>
    <time_frame>Baseline, 6 week follow-up</time_frame>
    <description>A psychometric questionnaire will assess action planning using a likert scale at baseline and 6 weeks follow-up.&#xD;
Action Planning: when, where and how an individual will engage in the recommended exercise. Psychometric questionnaire assessing Action Planning was administered at baseline and follow-up. The psychometric questionnaire used a 5 point likert scale. (0 represents worst performance) to 25 (best performance).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavior Change Outcome: Coping Planning</measure>
    <time_frame>Baseline, 6 week follow-up</time_frame>
    <description>A psychometric questionnaire will assess coping planning using a likert scale at baseline and 6 weeks follow-up.&#xD;
Coping Planning: assesses an individuals ability to overcome perceived barriers e.g. lack of time, poor weather. Psychometric questionnaire assessing coping planning was administered at baseline and follow-up. The psychometric questionnaire used a 5 point likert scale. (0 represents worst performance) to 20 (best performance).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavior Change Outcome: Coping Self-Efficacy</measure>
    <time_frame>Baseline, 6 week follow-up</time_frame>
    <description>A psychometric questionnaire will assess coping self-efficacy using a likert scale at baseline and 6 weeks follow-up.&#xD;
Coping Self-Efficacy: assesses an individuals belief in their ability to overcome barriers. Psychometric questionnaire assessing Coping Self-Efficacy was administered at baseline and follow-up. The psychometric questionnaire used a 5 point likert scale. (0 represents worst performance) to 45 (best performance).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavior Change Outcome: Intentions</measure>
    <time_frame>Baseline, 6 week follow-up</time_frame>
    <description>A psychometric questionnaire will assess intentions using a likert scale at baseline and 6 weeks follow-up.&#xD;
Intentions: assesses an individuals intention to engage in recommended exercises. Psychometric questionnaire assessing Intentions was administered at baseline and follow-up. The psychometric questionnaire used a 5 point likert scale. (0 represents worst performance) to 15 (best performance).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Related Quality of Life (HRQOL)</measure>
    <time_frame>Baseline, 6 week follow-up</time_frame>
    <description>The EQ-5D-5L questionnaire will be used to assess health related quality of life at baseline and at six weeks follow-up. The EQ-5D-5L questionnaire is very short and easy to complete making it ideal for a busy clinical setting. It consists of five questions which ask about pain, depression, activities, self-care and mobility. 0 (represents best performance) to 25 (represents worst performance).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Fall and Fractures Prevention</condition>
  <arm_group>
    <arm_group_label>Identify Patients at Risk/Exercise Prescription</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The intervention was delivered in two visits and two follow-up phone calls. Physician identifies that the patient is at risk of falls or fractures Visit one: individualized exercise prescription by a physiotherapist. Visit two: motivational interviewing (behavioural counselling) by kinesiologist Phone call 1 and 2: Kinesiologist reviews behavioural components (action planning, coping planning, coping self-efficacy, intentions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Identification of patients at risk, tailored exercise prescription, motivational interviewing, review of behavioural outcomes</intervention_name>
    <description>The intervention was delivered in two visits and two follow-up phone calls.&#xD;
Physician identifies that the patient is at risk of falls or fractures&#xD;
Visit one: individualized exercise prescription by a physiotherapist.&#xD;
Visit two: motivational interviewing (behavioural counselling) by kinesiologist&#xD;
Phone call 1 and 2: Kinesiologist reviews behavioural components (action planning, coping planning, coping self-efficacy, intentions.</description>
    <arm_group_label>Identify Patients at Risk/Exercise Prescription</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt; age 65&#xD;
&#xD;
          -  Patient of the Centre for Family Medicine Family Health Team (CFFM FHT)&#xD;
&#xD;
        Have at least one of the following:&#xD;
&#xD;
          -  2 or more falls in the past 12 months&#xD;
&#xD;
          -  age 75 +&#xD;
&#xD;
          -  high risk of fracture based on the CAROC&#xD;
&#xD;
          -  difficulty with walking or balance as determined by attending physician&#xD;
&#xD;
          -  acute fall&#xD;
&#xD;
          -  history of a fragility fracture after the age of 50&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  moderate to severe cognitive impairment&#xD;
&#xD;
          -  moderate to severe neurologic impairment&#xD;
&#xD;
          -  not able to communicate in English&#xD;
&#xD;
          -  contraindications to exercise as determined by physician&#xD;
&#xD;
          -  uncontrolled hypertension&#xD;
&#xD;
          -  palliative care, current cancer, on dialysis&#xD;
&#xD;
          -  participation in a similar exercise program including resistance training at least 3&#xD;
             times a week&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lora M Giangregorio, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Waterloo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre for Family Medicine (CFFM)</name>
      <address>
        <city>Kitchener</city>
        <state>Ontario</state>
        <zip>N2G 1C5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Boonen S, Dejaeger E, Vanderschueren D, Venken K, Bogaerts A, Verschueren S, Milisen K. Osteoporosis and osteoporotic fracture occurrence and prevention in the elderly: a geriatric perspective. Best Pract Res Clin Endocrinol Metab. 2008 Oct;22(5):765-85. doi: 10.1016/j.beem.2008.07.002.</citation>
    <PMID>19028356</PMID>
  </reference>
  <reference>
    <citation>Guideline for the prevention of falls in older persons. American Geriatrics Society, British Geriatrics Society, and American Academy of Orthopaedic Surgeons Panel on Falls Prevention. J Am Geriatr Soc. 2001 May;49(5):664-72. No abstract available.</citation>
    <PMID>11380764</PMID>
  </reference>
  <reference>
    <citation>Leslie WD, O'Donnell S, Jean S, Lagace C, Walsh P, Bancej C, Morin S, Hanley DA, Papaioannou A; Osteoporosis Surveillance Expert Working Group. Trends in hip fracture rates in Canada. JAMA. 2009 Aug 26;302(8):883-9. doi: 10.1001/jama.2009.1231.</citation>
    <PMID>19706862</PMID>
  </reference>
  <reference>
    <citation>Brown AP. Reducing falls in elderly people: A review of exercise interventions. Physiother Theory Pract 1999;15:59-68.</citation>
  </reference>
  <reference>
    <citation>Statistics Canada. Estimates of population, by age group and sex for July 1, Canada, provinces and territories, annual (CANSIM Table 051-0001). Ottawa: Statistics Canada 2010.</citation>
  </reference>
  <reference>
    <citation>World Health Organization. WHO Global Report on Falls Prevention in Older Age. Geneva, Switzerland: World Health Organization. 2007; Available at: http://www.who.int/ageing/publications/Falls_ prevention7March.pdf. Accessed Retrieved Aug, 2011.</citation>
  </reference>
  <reference>
    <citation>Consensus development conference: diagnosis, prophylaxis, and treatment of osteoporosis. Am J Med. 1993 Jun;94(6):646-50. doi: 10.1016/0002-9343(93)90218-e. No abstract available.</citation>
    <PMID>8506892</PMID>
  </reference>
  <reference>
    <citation>National Osteoporosis Foundation. America's bone health: the state of osteoporosis and low bone mass in our nation. Washington DC: National Osteoporosis Foundation. 2002.</citation>
  </reference>
  <reference>
    <citation>Ioannidis G, Papaioannou A, Hopman WM, Akhtar-Danesh N, Anastassiades T, Pickard L, Kennedy CC, Prior JC, Olszynski WP, Davison KS, Goltzman D, Thabane L, Gafni A, Papadimitropoulos EA, Brown JP, Josse RG, Hanley DA, Adachi JD. Relation between fractures and mortality: results from the Canadian Multicentre Osteoporosis Study. CMAJ. 2009 Sep 1;181(5):265-71. doi: 10.1503/cmaj.081720. Epub 2009 Aug 4.</citation>
    <PMID>19654194</PMID>
  </reference>
  <reference>
    <citation>Papaioannou A, Kennedy CC, Ioannidis G, Sawka A, Hopman WM, Pickard L, Brown JP, Josse RG, Kaiser S, Anastassiades T, Goltzman D, Papadimitropoulos M, Tenenhouse A, Prior JC, Olszynski WP, Adachi JD; CaMos Study Group. The impact of incident fractures on health-related quality of life: 5 years of data from the Canadian Multicentre Osteoporosis Study. Osteoporos Int. 2009 May;20(5):703-14. doi: 10.1007/s00198-008-0743-7. Epub 2008 Sep 19.</citation>
    <PMID>18802659</PMID>
  </reference>
  <reference>
    <citation>Wiktorowicz ME, Goeree R, Papaioannou A, Adachi JD, Papadimitropoulos E. Economic implications of hip fracture: health service use, institutional care and cost in Canada. Osteoporos Int. 2001;12(4):271-8. doi: 10.1007/s001980170116.</citation>
    <PMID>11420776</PMID>
  </reference>
  <reference>
    <citation>Papaioannou A, Morin S, Cheung AM, Atkinson S, Brown JP, Feldman S, Hanley DA, Hodsman A, Jamal SA, Kaiser SM, Kvern B, Siminoski K, Leslie WD; Scientific Advisory Council of Osteoporosis Canada. 2010 clinical practice guidelines for the diagnosis and management of osteoporosis in Canada: summary. CMAJ. 2010 Nov 23;182(17):1864-73. doi: 10.1503/cmaj.100771. Epub 2010 Oct 12. No abstract available.</citation>
    <PMID>20940232</PMID>
  </reference>
  <reference>
    <citation>Martyn-St James M, Carroll S. Meta-analysis of walking for preservation of bone mineral density in postmenopausal women. Bone. 2008 Sep;43(3):521-31. doi: 10.1016/j.bone.2008.05.012. Epub 2008 May 26.</citation>
    <PMID>18602880</PMID>
  </reference>
  <reference>
    <citation>Gillespie LD, Robertson MC, Gillespie WJ, Lamb SE, Gates S, Cumming RG, Rowe BH. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD007146. doi: 10.1002/14651858.CD007146.pub2.</citation>
    <PMID>19370674</PMID>
  </reference>
  <reference>
    <citation>Eakin EG, Glasgow RE, Riley KM. Review of primary care-based physical activity intervention studies: effectiveness and implications for practice and future research. J Fam Pract. 2000 Feb;49(2):158-68.</citation>
    <PMID>10718694</PMID>
  </reference>
  <reference>
    <citation>Health Council of Canada 2010. Family Physicians as Gatekeepers.</citation>
  </reference>
  <reference>
    <citation>Abramson S, Stein J, Schaufele M, Frates E, Rogan S. Personal exercise habits and counseling practices of primary care physicians: a national survey. Clin J Sport Med. 2000 Jan;10(1):40-8. doi: 10.1097/00042752-200001000-00008.</citation>
    <PMID>10695849</PMID>
  </reference>
  <reference>
    <citation>Yarnall KS, Pollak KI, Ostbye T, Krause KM, Michener JL. Primary care: is there enough time for prevention? Am J Public Health. 2003 Apr;93(4):635-41. doi: 10.2105/ajph.93.4.635.</citation>
    <PMID>12660210</PMID>
  </reference>
  <reference>
    <citation>Petrella RJ, Wight D. An office-based instrument for exercise counseling and prescription in primary care. The Step Test Exercise Prescription (STEP). Arch Fam Med. 2000 Apr;9(4):339-44. doi: 10.1001/archfami.9.4.339.</citation>
    <PMID>10776362</PMID>
  </reference>
  <reference>
    <citation>Nupponen R. What is counseling all about--basics in the counseling of health-related physical activity. Patient Educ Couns. 1998 Apr;33(1 Suppl):S61-7. doi: 10.1016/s0738-3991(98)00010-x.</citation>
    <PMID>10889747</PMID>
  </reference>
  <reference>
    <citation>Ritchie CS, Stetson BA, Bass PF 3rd, Adams KJ. Talking to patients about aerobic exercise for disease prevention: an educational exercise for medical students. Nutr Clin Care. 2002 May-Jun;5(3):103-14. doi: 10.1046/j.1523-5408.2002.00041.x.</citation>
    <PMID>12134565</PMID>
  </reference>
  <reference>
    <citation>Walsh JM, Swangard DM, Davis T, McPhee SJ. Exercise counseling by primary care physicians in the era of managed care. Am J Prev Med. 1999 May;16(4):307-13. doi: 10.1016/s0749-3797(99)00021-5.</citation>
    <PMID>10493287</PMID>
  </reference>
  <reference>
    <citation>Health Canada. Database on the Internet 2011; Available at: http://www.hc-sc.gc.ca/hl-vs/physactiv/index-eng.php. Accessed June 8 2011.</citation>
  </reference>
  <reference>
    <citation>Barling NR, Lehmann M. Young men's awareness, attitudes and practice of testicular self-examination: a Health Action Process Approach. Psychol Health Med 1999; 4(3):255-263.</citation>
  </reference>
  <reference>
    <citation>Cao D, Xie G. From intention to health behavior: An overview on Health Action Process Approach. Chinese Journal of Clinical Psychology 2010; 18(6):809-812.</citation>
  </reference>
  <reference>
    <citation>Chiu C. Testing schwarzer's health action process approach (HAPA) model of health promotion for people with multiple sclerosis: A path analytic approach. University of Wisconsin - Madison; 2009. 217 pp. Available from: UMI Order AAI3384139.:M1: Ph.D.</citation>
  </reference>
  <reference>
    <citation>Luszczynska A, Goc G, Scholz U, Kowalska M, Knoll N. Enhancing intentions to attend cervical cancer screening with a stage-matched intervention. Br J Health Psychol. 2011 Feb;16(Pt 1):33-46. doi: 10.1348/135910710X499416.</citation>
    <PMID>21226782</PMID>
  </reference>
  <reference>
    <citation>Schwarzer R, Luszczynska A. How to overcome health-compromising behaviors: The health action process approach. European Psychologist 2008; 13(2):141-151.</citation>
  </reference>
  <reference>
    <citation>Williams RJ, Herzog TA, Simmons VN. Risk perception and motivation to quit smoking: a partial test of the Health Action Process Approach. Addict Behav. 2011 Jul;36(7):789-91. doi: 10.1016/j.addbeh.2011.03.003. Epub 2011 Mar 21.</citation>
    <PMID>21463920</PMID>
  </reference>
  <reference>
    <citation>Schwarzer R. Self-efficacy: Thought control of action. Self-efficacy in the adoption and maintenance of health behaviors: Theoretical approaches and a new model. Washington: Hemisphere; 1992. p. 217-243.</citation>
  </reference>
  <reference>
    <citation>Luszczynska A, Schwarzer R. Planning and self-efficacy in the adoption and maintenance of breast self-examination: A longitudinal study on self-regulatory cognitions. Psychology and Health 2003; 18:93-108.</citation>
  </reference>
  <reference>
    <citation>Renner B, Spivak Y, Kwon S, Schwarzer R. Does age make a difference? Predicting physical activity of South Koreans. Psychol Aging. 2007 Sep;22(3):482-93. doi: 10.1037/0882-7974.22.3.482.</citation>
    <PMID>17874949</PMID>
  </reference>
  <reference>
    <citation>Buman MP, Hekler EB, Haskell WL, Pruitt L, Conway TL, Cain KL, Sallis JF, Saelens BE, Frank LD, King AC. Objective light-intensity physical activity associations with rated health in older adults. Am J Epidemiol. 2010 Nov 15;172(10):1155-65. doi: 10.1093/aje/kwq249. Epub 2010 Sep 15.</citation>
    <PMID>20843864</PMID>
  </reference>
  <reference>
    <citation>Gerdhem P, Dencker M, Ringsberg K, Akesson K. Accelerometer-measured daily physical activity among octogenerians: results and associations to other indices of physical performance and bone density. Eur J Appl Physiol. 2008 Jan;102(2):173-80. doi: 10.1007/s00421-007-0571-z. Epub 2007 Sep 29. Erratum In: Eur J Appl Physiol. 2008 Apr;102(6):747.</citation>
    <PMID>17906874</PMID>
  </reference>
  <reference>
    <citation>Matthews CE, Ainsworth BE, Thompson RW, Bassett DR Jr. Sources of variance in daily physical activity levels as measured by an accelerometer. Med Sci Sports Exerc. 2002 Aug;34(8):1376-81. doi: 10.1097/00005768-200208000-00021.</citation>
    <PMID>12165695</PMID>
  </reference>
  <reference>
    <citation>Hughes DA. Feasibility, validity and reliability of the Welsh version of the EQ-5D health status questionnaire. Qual Life Res. 2007 Oct;16(8):1419-23. doi: 10.1007/s11136-007-9238-9. Epub 2007 Jul 25.</citation>
    <PMID>17653613</PMID>
  </reference>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <results_first_submitted>June 14, 2017</results_first_submitted>
  <results_first_submitted_qc>October 10, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">February 18, 2019</results_first_posted>
  <last_update_submitted>October 10, 2018</last_update_submitted>
  <last_update_submitted_qc>October 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Falls, Fractures, Osteoporosis, Frailty, Older Adults.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>No pre-assignment of participants to groups.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Identify Patients at Risk/Exercise Prescription</title>
          <description>The intervention was delivered in two visits and two follow-up phone calls. Physician identifies that the patient is at risk of falls or fractures Visit one: individualized exercise prescription by a physiotherapist.Visit two: motivational interviewing (behavioural counselling) by kinesiologist Phone call 1 and 2: Kinesiologist reviews behavioural components (action planning, coping planning, coping self-efficacy, intentions.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Identify Patients at Risk/Exercise Prescription</title>
          <description>The intervention was delivered in two visits and two follow-up phone calls. Physician identifies that the patient is at risk of falls or fractures Visit one: individualized exercise prescription by a physiotherapist. Visit two: motivational interviewing (behavioural counselling) by kinesiologist Phone call 1 and 2: Kinesiologist reviews behavioural components (action planning, coping planning, coping self-efficacy, intentions.&#xD;
Identification of patients at risk, tailored exercise prescription, motivational interviewing, review of behavioural outcomes: The intervention was delivered in two visits and two follow-up phone calls.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="11"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Canada</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sedentary</title>
          <units>min/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="546.2" spread="274.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Low Light Physical Activity</title>
          <units>min/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="211.3" spread="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>High Light Physical Activity</title>
          <units>min/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.8" spread="24.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Moderate to Vigorous Physical Activity</title>
          <units>min/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.7" spread="22.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Short Physical Performance Battery</title>
          <description>Short Physical Performance Battery Served as a Functional Assessment at Baseline and Follow-up: 0 (represents worst performance) to 12 (represents best performance).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.91" spread="3.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Timed Up and Go (TUG)</title>
          <description>Timed Up and Go was a functional assessment taken at baseline and follow-up. A score of more than or equal to 14 seconds has been shown to indicate high risk of falls.</description>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13.95" spread="6.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Coping Planning</title>
          <description>Psychometric questionnaire assessing coping planning was administered at baseline and follow-up. The psychometric questionnaire used a 5 point Likert scale to assess four constructs related to planning behaviour for interference in the participant's exercise routine. The minimum score of 4 represents the least degree of concrete planning for mitigate interference to the participant's exercise routine and the maximal score of 20 indicates a high degree of planning.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10.45" spread="3.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Action Planning</title>
          <description>Psychometric questionnaire assessing Action Planning was administered at baseline and follow-up. The psychometric questionnaire used a 5 point likert scale to assess five constructs related to planning behaviour for creating the participant's exercise routine. The minimum score of 5 represents the least degree of concrete planning for the participant's exercise routine and the maximal score of 25 indicates a high degree of planning.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16.45" spread="5.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Coping Self-Efficacy</title>
          <description>Psychometric questionnaire assessing Coping Self-Efficacy was administered at baseline and follow-up. The psychometric questionnaire used a 5 point likert scale to assess eight constructs related to self-reported psychological interference in the participant's exercise routine. The minimum score of 8 represents the least amount of self-reported ability to mitigate interference to the participant's exercise routine and the maximal score of 45 indicates a high degree of self-reported resilience .</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.55" spread="6.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Intentions</title>
          <description>Psychometric questionnaire assessing Intentions was administered at baseline and follow-up. The psychometric questionnaire used a 5 point likert scale to assess three constructs related to the participant's intentions for exercising over the next 6 weeks. The minimum score of 3 represents the least degree of intention to exercise at the prescribed amount over the next 6 weeks and the maximal score of 15 indicates a high degree of intention to exercise.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11.73" spread="2.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>EQ-5D-5L (HRQOL)</title>
          <description>The EQ-5D-5L questionnaire will be used to assess health related quality of life at baseline and at six weeks follow-up. The EQ-5D-5L questionnaire is very short and easy to complete making it ideal for a busy clinical setting. It consists of five questions which ask about pain, depression, activities, self-care and mobility. 0 (represents best performance) to 25 (represents worst performance).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.05" spread="1.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Physical Activity (Reporting Change in Physical Activity From Baseline to Six-week Follow-up)</title>
        <description>The X2-Mini accelerometer (Gulf Coast Data Concepts.,USA) is a three-dimensional sensor that is used to capture the activity levels of an individual. The accelerometer is worn on the hip of the participant for four days. The number of minutes that the individual spends in each exercise intensity category is acquired. Accelerometer thresholds make up four categories of activity: (1) sedentary; (2) low-light; (3) high-light; (4) moderate-vigorous. Activity monitors have been indicated as the most accurate means of measuring physical activity levels.</description>
        <time_frame>Baseline, 6 week follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Identify Patients at Risk/Exercise Prescription</title>
            <description>The intervention was delivered in two visits and two follow-up phone calls. Physician identifies that the patient is at risk of falls or fractures Visit one: individualized exercise prescription by a physiotherapist. Visit two: motivational interviewing (behavioural counselling) by kinesiologist Phone call 1 and 2: Kinesiologist reviews behavioural components (action planning, coping planning, coping self-efficacy, intentions.&#xD;
Identification of patients at risk, tailored exercise prescription, motivational interviewing, review of behavioural outcomes: The intervention was delivered in two visits and two follow-up phone calls.</description>
          </group>
        </group_list>
        <measure>
          <title>Physical Activity (Reporting Change in Physical Activity From Baseline to Six-week Follow-up)</title>
          <description>The X2-Mini accelerometer (Gulf Coast Data Concepts.,USA) is a three-dimensional sensor that is used to capture the activity levels of an individual. The accelerometer is worn on the hip of the participant for four days. The number of minutes that the individual spends in each exercise intensity category is acquired. Accelerometer thresholds make up four categories of activity: (1) sedentary; (2) low-light; (3) high-light; (4) moderate-vigorous. Activity monitors have been indicated as the most accurate means of measuring physical activity levels.</description>
          <units>minutes/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.6" spread="15.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Physical Activity (Self-report) (Reporting Change in Physical Activity From Baseline to Six-week Follow-up)</title>
        <description>Participants complete a physical activity log book daily in order to document their completion of the prescribed exercises and list any additional activities that they may have been engaged in. The percentage of prescribed exercises completed are reported (for e.g. if participants completed 2 of 3 prescribed exercise then the reported percentage would be 67%). Mean (SD) are reported.</description>
        <time_frame>Baseline, 6 week follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Identify Patients at Risk/Exercise Prescription</title>
            <description>The intervention was delivered in two visits and two follow-up phone calls. Physician identifies that the patient is at risk of falls or fractures Visit one: individualized exercise prescription by a physiotherapist. Visit two: motivational interviewing (behavioural counselling) by kinesiologist Phone call 1 and 2: Kinesiologist reviews behavioural components (action planning, coping planning, coping self-efficacy, intentions.&#xD;
Identification of patients at risk, tailored exercise prescription, motivational interviewing, review of behavioural outcomes: The intervention was delivered in two visits and two follow-up phone calls.</description>
          </group>
        </group_list>
        <measure>
          <title>Physical Activity (Self-report) (Reporting Change in Physical Activity From Baseline to Six-week Follow-up)</title>
          <description>Participants complete a physical activity log book daily in order to document their completion of the prescribed exercises and list any additional activities that they may have been engaged in. The percentage of prescribed exercises completed are reported (for e.g. if participants completed 2 of 3 prescribed exercise then the reported percentage would be 67%). Mean (SD) are reported.</description>
          <units>percentage of completed exercise</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.7" spread="23.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Behavior Change Outcome: Action Planning</title>
        <description>A psychometric questionnaire will assess action planning using a likert scale at baseline and 6 weeks follow-up.&#xD;
Action Planning: when, where and how an individual will engage in the recommended exercise. Psychometric questionnaire assessing Action Planning was administered at baseline and follow-up. The psychometric questionnaire used a 5 point likert scale. (0 represents worst performance) to 25 (best performance).</description>
        <time_frame>Baseline, 6 week follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Identify Patients at Risk/Exercise Prescription</title>
            <description>The intervention was delivered in two visits and two follow-up phone calls. Physician identifies that the patient is at risk of falls or fractures Visit one: individualized exercise prescription by a physiotherapist. Visit two: motivational interviewing (behavioural counselling) by kinesiologist Phone call 1 and 2: Kinesiologist reviews behavioural components (action planning, coping planning, coping self-efficacy, intentions.&#xD;
Identification of patients at risk, tailored exercise prescription, motivational interviewing, review of behavioural outcomes: The intervention was delivered in two visits and two follow-up phone calls.</description>
          </group>
        </group_list>
        <measure>
          <title>Behavior Change Outcome: Action Planning</title>
          <description>A psychometric questionnaire will assess action planning using a likert scale at baseline and 6 weeks follow-up.&#xD;
Action Planning: when, where and how an individual will engage in the recommended exercise. Psychometric questionnaire assessing Action Planning was administered at baseline and follow-up. The psychometric questionnaire used a 5 point likert scale. (0 represents worst performance) to 25 (best performance).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.00" spread="1.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Behavior Change Outcome: Coping Planning</title>
        <description>A psychometric questionnaire will assess coping planning using a likert scale at baseline and 6 weeks follow-up.&#xD;
Coping Planning: assesses an individuals ability to overcome perceived barriers e.g. lack of time, poor weather. Psychometric questionnaire assessing coping planning was administered at baseline and follow-up. The psychometric questionnaire used a 5 point likert scale. (0 represents worst performance) to 20 (best performance).</description>
        <time_frame>Baseline, 6 week follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Identify Patients at Risk/Exercise Prescription</title>
            <description>The intervention was delivered in two visits and two follow-up phone calls. Physician identifies that the patient is at risk of falls or fractures Visit one: individualized exercise prescription by a physiotherapist. Visit two: motivational interviewing (behavioural counselling) by kinesiologist Phone call 1 and 2: Kinesiologist reviews behavioural components (action planning, coping planning, coping self-efficacy, intentions.&#xD;
Identification of patients at risk, tailored exercise prescription, motivational interviewing, review of behavioural outcomes: The intervention was delivered in two visits and two follow-up phone calls.</description>
          </group>
        </group_list>
        <measure>
          <title>Behavior Change Outcome: Coping Planning</title>
          <description>A psychometric questionnaire will assess coping planning using a likert scale at baseline and 6 weeks follow-up.&#xD;
Coping Planning: assesses an individuals ability to overcome perceived barriers e.g. lack of time, poor weather. Psychometric questionnaire assessing coping planning was administered at baseline and follow-up. The psychometric questionnaire used a 5 point likert scale. (0 represents worst performance) to 20 (best performance).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.55" spread="1.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Behavior Change Outcome: Coping Self-Efficacy</title>
        <description>A psychometric questionnaire will assess coping self-efficacy using a likert scale at baseline and 6 weeks follow-up.&#xD;
Coping Self-Efficacy: assesses an individuals belief in their ability to overcome barriers. Psychometric questionnaire assessing Coping Self-Efficacy was administered at baseline and follow-up. The psychometric questionnaire used a 5 point likert scale. (0 represents worst performance) to 45 (best performance).</description>
        <time_frame>Baseline, 6 week follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Identify Patients at Risk/Exercise Prescription</title>
            <description>The intervention was delivered in two visits and two follow-up phone calls. Physician identifies that the patient is at risk of falls or fractures Visit one: individualized exercise prescription by a physiotherapist. Visit two: motivational interviewing (behavioural counselling) by kinesiologist Phone call 1 and 2: Kinesiologist reviews behavioural components (action planning, coping planning, coping self-efficacy, intentions.&#xD;
Identification of patients at risk, tailored exercise prescription, motivational interviewing, review of behavioural outcomes: The intervention was delivered in two visits and two follow-up phone calls.</description>
          </group>
        </group_list>
        <measure>
          <title>Behavior Change Outcome: Coping Self-Efficacy</title>
          <description>A psychometric questionnaire will assess coping self-efficacy using a likert scale at baseline and 6 weeks follow-up.&#xD;
Coping Self-Efficacy: assesses an individuals belief in their ability to overcome barriers. Psychometric questionnaire assessing Coping Self-Efficacy was administered at baseline and follow-up. The psychometric questionnaire used a 5 point likert scale. (0 represents worst performance) to 45 (best performance).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.45" spread="4.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Behavior Change Outcome: Intentions</title>
        <description>A psychometric questionnaire will assess intentions using a likert scale at baseline and 6 weeks follow-up.&#xD;
Intentions: assesses an individuals intention to engage in recommended exercises. Psychometric questionnaire assessing Intentions was administered at baseline and follow-up. The psychometric questionnaire used a 5 point likert scale. (0 represents worst performance) to 15 (best performance).</description>
        <time_frame>Baseline, 6 week follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Identify Patients at Risk/Exercise Prescription</title>
            <description>The intervention was delivered in two visits and two follow-up phone calls. Physician identifies that the patient is at risk of falls or fractures Visit one: individualized exercise prescription by a physiotherapist. Visit two: motivational interviewing (behavioural counselling) by kinesiologist Phone call 1 and 2: Kinesiologist reviews behavioural components (action planning, coping planning, coping self-efficacy, intentions.&#xD;
Identification of patients at risk, tailored exercise prescription, motivational interviewing, review of behavioural outcomes: The intervention was delivered in two visits and two follow-up phone calls.</description>
          </group>
        </group_list>
        <measure>
          <title>Behavior Change Outcome: Intentions</title>
          <description>A psychometric questionnaire will assess intentions using a likert scale at baseline and 6 weeks follow-up.&#xD;
Intentions: assesses an individuals intention to engage in recommended exercises. Psychometric questionnaire assessing Intentions was administered at baseline and follow-up. The psychometric questionnaire used a 5 point likert scale. (0 represents worst performance) to 15 (best performance).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.0" spread="1.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Health Related Quality of Life (HRQOL)</title>
        <description>The EQ-5D-5L questionnaire will be used to assess health related quality of life at baseline and at six weeks follow-up. The EQ-5D-5L questionnaire is very short and easy to complete making it ideal for a busy clinical setting. It consists of five questions which ask about pain, depression, activities, self-care and mobility. 0 (represents best performance) to 25 (represents worst performance).</description>
        <time_frame>Baseline, 6 week follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Identify Patients at Risk/Exercise Prescription</title>
            <description>The intervention was delivered in two visits and two follow-up phone calls. Physician identifies that the patient is at risk of falls or fractures Visit one: individualized exercise prescription by a physiotherapist. Visit two: motivational interviewing (behavioural counselling) by kinesiologist Phone call 1 and 2: Kinesiologist reviews behavioural components (action planning, coping planning, coping self-efficacy, intentions.&#xD;
Identification of patients at risk, tailored exercise prescription, motivational interviewing, review of behavioural outcomes: The intervention was delivered in two visits and two follow-up phone calls.</description>
          </group>
        </group_list>
        <measure>
          <title>Health Related Quality of Life (HRQOL)</title>
          <description>The EQ-5D-5L questionnaire will be used to assess health related quality of life at baseline and at six weeks follow-up. The EQ-5D-5L questionnaire is very short and easy to complete making it ideal for a busy clinical setting. It consists of five questions which ask about pain, depression, activities, self-care and mobility. 0 (represents best performance) to 25 (represents worst performance).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <p_value_desc>&lt;0.05 (threshold for significance).</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Identify Patients at Risk/Exercise Prescription</title>
          <description>The intervention was delivered in two visits and two follow-up phone calls. Physician identifies that the patient is at risk of falls or fractures Visit one: individualized exercise prescription by a physiotherapist. Visit two: motivational interviewing (behavioural counselling) by kinesiologist Phone call 1 and 2: Kinesiologist reviews behavioural components (action planning, coping planning, coping self-efficacy, intentions.&#xD;
Identification of patients at risk, tailored exercise prescription, motivational interviewing, review of behavioural outcomes: The intervention was delivered in two visits and two follow-up phone calls.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Small sample size and short study duration. Use of accelerometers to objectively capture physical activity (not all activity is captured by the accelerometers) and use of self-report physical activity logs. Possible self motivated participants.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Lora Giangregorio</name_or_title>
      <organization>University of Waterloo</organization>
      <phone>(519) 888-4567 ext 36357</phone>
      <email>lmgiangr@uwaterloo.ca</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01698463
org study id: 17664
nct id: NCT01698463
lead sponsor: 
collaborator: 
has dmc: No
Falls and fractures are a leading cause of death and disability in the older adult
      population. The consequences of falls and fractures contribute substantially to health care
      costs and can have a significant negative impact on the quality of life of the individual.
      Exercise has been studied as an option to reduce fracture risk and prevent falls though
      improving balance and muscle strength. The prevention of falls is important, as a history of
      falls is strongly predictive of suffering another. Those who are at a high risk of fracture
      or falling require a patient specific assessment and individualized exercise prescription
      that is tailored to their needs. This kind of program may not be typically available within
      the community and at a low cost. These individuals may experience difficulty when trying to
      engage in exercise due to barriers such as a lack of transportation, and a lack of knowledge.
      As the first point of contact with the health care system for many family doctors are in the
      ideal position to deliver exercise advice to their patients. However, a lack of time and
      specialized skills in prescribing exercise make this difficult for many of them. As a result,
      family health teams who provide interdisciplinary patient centered care are becoming popular.
      In this model the care is shared and provided by the most appropriate team member (e.g.
      doctor, nurse, exercise specialist). Additionally, many exercise interventions do not include
      a behavior change aspect, which may be an important component when trying to get individuals
      to engage in a new health behavior like exercise. Therefore the purpose of this project is to
      assess the feasibility of implementing a tailored exercise program to those at high risk of
      falls or fractures over the age of 65 in a primary care setting using an interdisciplinary
      model of care that is based on a health behaviour change model.
Falls and fractures together represent one of the leading causes of morbidity and mortality
      within the older adult population. Additionally, the consequences of falls and fractures
      contribute substantial costs to the health care system and negatively impact the quality of
      life of the individual. Given that Canada's aging population in increasing at an
      unprecedented rate, it is imperative that the prevention and management of falls and
      fractures is made a priority. One such population particularly vulnerable to falls and
      fractures are those diagnosed with osteoporosis or low bone mass.

      It has been estimated that approximately 10 billion individuals have been diagnosed with
      osteoporosis and another 34 million are at risk with low bone mass. Osteoporosis-related
      fragility fractures are a common consequence of osteoporosis and result in increased
      morbidity and mortality. Approximately 50% of those who suffer a hip fracture do not regain
      their previous level of mobility and functional independence thus resulting in many of these
      individuals relying on the use of assistive devices.

      Currently the emphasis of osteoporosis treatment and management is to prevent the occurrence
      of fragility fractures and the subsequent side effects that accompany them. A recent
      meta-analysis has shown that exercise can assist in the prevention and maintenance of bone
      loss in postmenopausal women. Other benefits of exercise such as increases in muscle strength
      and balance have been strongly established to indirectly prevent fractures through a
      reduction in falls risk. Those who are at a high risk of falls or fracture require patient
      specific assessment and individualized prescription that is not typically available within
      the community or at a low cost. Further, it may be difficult to engage these individuals if
      they have spent most of their life in a sedentary state and experience barriers such as a
      lack of transportation, and a lack of knowledge on appropriate types of exercise or how to
      initiate exercise into their daily living. Furthermore, many exercises may not be appropriate
      for all individuals depending on location of fracture and level of physical function. It has
      been emphasized that the focus should be on an individualized exercise program, which would
      encompass individual needs while recognizing individual limitations.

      Family physicians may be in an ideal position to deliver an exercise prescription to a
      patient, as they are often the first point of contact with the health care system. However,
      there have been a number of problems cited with using family physicians to implement the
      delivery of an exercise prescription. Among those barriers, a lack of time and a lack of
      knowledge have been identified as the most problematic. An interdisciplinary family health
      team model of care is becoming increasingly important in regards to the treatment of chronic
      conditions such as osteoporosis. Family health teams provide an ideal form of care where team
      members work together to deliver the program and enhance adherence.

      A limitation of many exercise interventions is that they fail to include a behavior change
      component which may be an important factor to consider when attempting to facilitate
      adherence to an exercise program. The Health Action Process Approach is a model of behavior
      change that has been widely used in a variety of health contexts including but not limited to
      physical activity. The rationale for the selection of this model is that it incorporates key
      principles of other behavior change models. Furthermore, the model has been cited as being a
      valid and reliable tool for predicting physical activity levels in older adults.

      This project outlines an exercise intervention that is multidisciplinary in nature and
      tailored to the individual to be employed within an interdisciplinary family health team.
      Additionally, a behavior change component is built into this intervention with key principles
      such as action planning and coping planning that are based on the HAPA model to facilitate
      the uptake of physical activity in this vulnerable population.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Physical Activity (Reporting Change in Physical Activity From Baseline to Six-week Follow-up)
time frame: Baseline, 6 week follow-up
description: The X2-Mini accelerometer (Gulf Coast Data Concepts.,USA) is a three-dimensional sensor that is used to capture the activity levels of an individual. The accelerometer is worn on the hip of the participant for four days. The number of minutes that the individual spends in each exercise intensity category is acquired. Accelerometer thresholds make up four categories of activity: (1) sedentary; (2) low-light; (3) high-light; (4) moderate-vigorous. Activity monitors have been indicated as the most accurate means of measuring physical activity levels.
measure: Physical Activity (Self-report) (Reporting Change in Physical Activity From Baseline to Six-week Follow-up)
time frame: Baseline, 6 week follow-up
description: Participants complete a physical activity log book daily in order to document their completion of the prescribed exercises and list any additional activities that they may have been engaged in. The percentage of prescribed exercises completed are reported (for e.g. if participants completed 2 of 3 prescribed exercise then the reported percentage would be 67%). Mean (SD) are reported.
measure: Behavior Change Outcome: Action Planning
time frame: Baseline, 6 week follow-up
description: A psychometric questionnaire will assess action planning using a likert scale at baseline and 6 weeks follow-up.
Action Planning: when, where and how an individual will engage in the recommended exercise. Psychometric questionnaire assessing Action Planning was administered at baseline and follow-up. The psychometric questionnaire used a 5 point likert scale. (0 represents worst performance) to 25 (best performance).
measure: Behavior Change Outcome: Coping Planning
time frame: Baseline, 6 week follow-up
description: A psychometric questionnaire will assess coping planning using a likert scale at baseline and 6 weeks follow-up.
Coping Planning: assesses an individuals ability to overcome perceived barriers e.g. lack of time, poor weather. Psychometric questionnaire assessing coping planning was administered at baseline and follow-up. The psychometric questionnaire used a 5 point likert scale. (0 represents worst performance) to 20 (best performance).
measure: Behavior Change Outcome: Coping Self-Efficacy
time frame: Baseline, 6 week follow-up
description: A psychometric questionnaire will assess coping self-efficacy using a likert scale at baseline and 6 weeks follow-up.
Coping Self-Efficacy: assesses an individuals belief in their ability to overcome barriers. Psychometric questionnaire assessing Coping Self-Efficacy was administered at baseline and follow-up. The psychometric questionnaire used a 5 point likert scale. (0 represents worst performance) to 45 (best performance).
measure: Behavior Change Outcome: Intentions
time frame: Baseline, 6 week follow-up
description: A psychometric questionnaire will assess intentions using a likert scale at baseline and 6 weeks follow-up.
Intentions: assesses an individuals intention to engage in recommended exercises. Psychometric questionnaire assessing Intentions was administered at baseline and follow-up. The psychometric questionnaire used a 5 point likert scale. (0 represents worst performance) to 15 (best performance).
measure: Health Related Quality of Life (HRQOL)
time frame: Baseline, 6 week follow-up
description: The EQ-5D-5L questionnaire will be used to assess health related quality of life at baseline and at six weeks follow-up. The EQ-5D-5L questionnaire is very short and easy to complete making it ideal for a busy clinical setting. It consists of five questions which ask about pain, depression, activities, self-care and mobility. 0 (represents best performance) to 25 (represents worst performance).
arm group label: Identify Patients at Risk/Exercise Prescription
arm group type: Other
description: The intervention was delivered in two visits and two follow-up phone calls. Physician identifies that the patient is at risk of falls or fractures Visit one: individualized exercise prescription by a physiotherapist. Visit two: motivational interviewing (behavioural counselling) by kinesiologist Phone call 1 and 2: Kinesiologist reviews behavioural components (action planning, coping planning, coping self-efficacy, intentions.
intervention type: Other
intervention name: Identification of patients at risk, tailored exercise prescription, motivational interviewing, review of behavioural outcomes
description: The intervention was delivered in two visits and two follow-up phone calls.
Physician identifies that the patient is at risk of falls or fractures
Visit one: individualized exercise prescription by a physiotherapist.
Visit two: motivational interviewing (behavioural counselling) by kinesiologist
Phone call 1 and 2: Kinesiologist reviews behavioural components (action planning, coping planning, coping self-efficacy, intentions.
arm group label: Identify Patients at Risk/Exercise Prescription
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Lora M Giangregorio, PhD
role: Principal Investigator
affiliation: University of Waterloo
facility: 
country: Canada
citation: Boonen S, Dejaeger E, Vanderschueren D, Venken K, Bogaerts A, Verschueren S, Milisen K. Osteoporosis and osteoporotic fracture occurrence and prevention in the elderly: a geriatric perspective. Best Pract Res Clin Endocrinol Metab. 2008 Oct;22(5):765-85. doi: 10.1016/j.beem.2008.07.002.
PMID: 19028356
citation: Guideline for the prevention of falls in older persons. American Geriatrics Society, British Geriatrics Society, and American Academy of Orthopaedic Surgeons Panel on Falls Prevention. J Am Geriatr Soc. 2001 May;49(5):664-72. No abstract available.
PMID: 11380764
citation: Leslie WD, O'Donnell S, Jean S, Lagace C, Walsh P, Bancej C, Morin S, Hanley DA, Papaioannou A; Osteoporosis Surveillance Expert Working Group. Trends in hip fracture rates in Canada. JAMA. 2009 Aug 26;302(8):883-9. doi: 10.1001/jama.2009.1231.
PMID: 19706862
citation: Brown AP. Reducing falls in elderly people: A review of exercise interventions. Physiother Theory Pract 1999;15:59-68.
citation: Statistics Canada. Estimates of population, by age group and sex for July 1, Canada, provinces and territories, annual (CANSIM Table 051-0001). Ottawa: Statistics Canada 2010.
citation: World Health Organization. WHO Global Report on Falls Prevention in Older Age. Geneva, Switzerland: World Health Organization. 2007; Available at: http://www.who.int/ageing/publications/Falls_ prevention7March.pdf. Accessed Retrieved Aug, 2011.
citation: Consensus development conference: diagnosis, prophylaxis, and treatment of osteoporosis. Am J Med. 1993 Jun;94(6):646-50. doi: 10.1016/0002-9343(93)90218-e. No abstract available.
PMID: 8506892
citation: National Osteoporosis Foundation. America's bone health: the state of osteoporosis and low bone mass in our nation. Washington DC: National Osteoporosis Foundation. 2002.
citation: Ioannidis G, Papaioannou A, Hopman WM, Akhtar-Danesh N, Anastassiades T, Pickard L, Kennedy CC, Prior JC, Olszynski WP, Davison KS, Goltzman D, Thabane L, Gafni A, Papadimitropoulos EA, Brown JP, Josse RG, Hanley DA, Adachi JD. Relation between fractures and mortality: results from the Canadian Multicentre Osteoporosis Study. CMAJ. 2009 Sep 1;181(5):265-71. doi: 10.1503/cmaj.081720. Epub 2009 Aug 4.
PMID: 19654194
citation: Papaioannou A, Kennedy CC, Ioannidis G, Sawka A, Hopman WM, Pickard L, Brown JP, Josse RG, Kaiser S, Anastassiades T, Goltzman D, Papadimitropoulos M, Tenenhouse A, Prior JC, Olszynski WP, Adachi JD; CaMos Study Group. The impact of incident fractures on health-related quality of life: 5 years of data from the Canadian Multicentre Osteoporosis Study. Osteoporos Int. 2009 May;20(5):703-14. doi: 10.1007/s00198-008-0743-7. Epub 2008 Sep 19.
PMID: 18802659
citation: Wiktorowicz ME, Goeree R, Papaioannou A, Adachi JD, Papadimitropoulos E. Economic implications of hip fracture: health service use, institutional care and cost in Canada. Osteoporos Int. 2001;12(4):271-8. doi: 10.1007/s001980170116.
PMID: 11420776
citation: Papaioannou A, Morin S, Cheung AM, Atkinson S, Brown JP, Feldman S, Hanley DA, Hodsman A, Jamal SA, Kaiser SM, Kvern B, Siminoski K, Leslie WD; Scientific Advisory Council of Osteoporosis Canada. 2010 clinical practice guidelines for the diagnosis and management of osteoporosis in Canada: summary. CMAJ. 2010 Nov 23;182(17):1864-73. doi: 10.1503/cmaj.100771. Epub 2010 Oct 12. No abstract available.
PMID: 20940232
citation: Martyn-St James M, Carroll S. Meta-analysis of walking for preservation of bone mineral density in postmenopausal women. Bone. 2008 Sep;43(3):521-31. doi: 10.1016/j.bone.2008.05.012. Epub 2008 May 26.
PMID: 18602880
citation: Gillespie LD, Robertson MC, Gillespie WJ, Lamb SE, Gates S, Cumming RG, Rowe BH. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD007146. doi: 10.1002/14651858.CD007146.pub2.
PMID: 19370674
citation: Eakin EG, Glasgow RE, Riley KM. Review of primary care-based physical activity intervention studies: effectiveness and implications for practice and future research. J Fam Pract. 2000 Feb;49(2):158-68.
PMID: 10718694
citation: Health Council of Canada 2010. Family Physicians as Gatekeepers.
citation: Abramson S, Stein J, Schaufele M, Frates E, Rogan S. Personal exercise habits and counseling practices of primary care physicians: a national survey. Clin J Sport Med. 2000 Jan;10(1):40-8. doi: 10.1097/00042752-200001000-00008.
PMID: 10695849
citation: Yarnall KS, Pollak KI, Ostbye T, Krause KM, Michener JL. Primary care: is there enough time for prevention? Am J Public Health. 2003 Apr;93(4):635-41. doi: 10.2105/ajph.93.4.635.
PMID: 12660210
citation: Petrella RJ, Wight D. An office-based instrument for exercise counseling and prescription in primary care. The Step Test Exercise Prescription (STEP). Arch Fam Med. 2000 Apr;9(4):339-44. doi: 10.1001/archfami.9.4.339.
PMID: 10776362
citation: Nupponen R. What is counseling all about--basics in the counseling of health-related physical activity. Patient Educ Couns. 1998 Apr;33(1 Suppl):S61-7. doi: 10.1016/s0738-3991(98)00010-x.
PMID: 10889747
citation: Ritchie CS, Stetson BA, Bass PF 3rd, Adams KJ. Talking to patients about aerobic exercise for disease prevention: an educational exercise for medical students. Nutr Clin Care. 2002 May-Jun;5(3):103-14. doi: 10.1046/j.1523-5408.2002.00041.x.
PMID: 12134565
citation: Walsh JM, Swangard DM, Davis T, McPhee SJ. Exercise counseling by primary care physicians in the era of managed care. Am J Prev Med. 1999 May;16(4):307-13. doi: 10.1016/s0749-3797(99)00021-5.
PMID: 10493287
citation: Health Canada. Database on the Internet 2011; Available at: http://www.hc-sc.gc.ca/hl-vs/physactiv/index-eng.php. Accessed June 8 2011.
citation: Barling NR, Lehmann M. Young men's awareness, attitudes and practice of testicular self-examination: a Health Action Process Approach. Psychol Health Med 1999; 4(3):255-263.
citation: Cao D, Xie G. From intention to health behavior: An overview on Health Action Process Approach. Chinese Journal of Clinical Psychology 2010; 18(6):809-812.
citation: Chiu C. Testing schwarzer's health action process approach (HAPA) model of health promotion for people with multiple sclerosis: A path analytic approach. University of Wisconsin - Madison; 2009. 217 pp. Available from: UMI Order AAI3384139.:M1: Ph.D.
citation: Luszczynska A, Goc G, Scholz U, Kowalska M, Knoll N. Enhancing intentions to attend cervical cancer screening with a stage-matched intervention. Br J Health Psychol. 2011 Feb;16(Pt 1):33-46. doi: 10.1348/135910710X499416.
PMID: 21226782
citation: Schwarzer R, Luszczynska A. How to overcome health-compromising behaviors: The health action process approach. European Psychologist 2008; 13(2):141-151.
citation: Williams RJ, Herzog TA, Simmons VN. Risk perception and motivation to quit smoking: a partial test of the Health Action Process Approach. Addict Behav. 2011 Jul;36(7):789-91. doi: 10.1016/j.addbeh.2011.03.003. Epub 2011 Mar 21.
PMID: 21463920
citation: Schwarzer R. Self-efficacy: Thought control of action. Self-efficacy in the adoption and maintenance of health behaviors: Theoretical approaches and a new model. Washington: Hemisphere; 1992. p. 217-243.
citation: Luszczynska A, Schwarzer R. Planning and self-efficacy in the adoption and maintenance of breast self-examination: A longitudinal study on self-regulatory cognitions. Psychology and Health 2003; 18:93-108.
citation: Renner B, Spivak Y, Kwon S, Schwarzer R. Does age make a difference? Predicting physical activity of South Koreans. Psychol Aging. 2007 Sep;22(3):482-93. doi: 10.1037/0882-7974.22.3.482.
PMID: 17874949
citation: Buman MP, Hekler EB, Haskell WL, Pruitt L, Conway TL, Cain KL, Sallis JF, Saelens BE, Frank LD, King AC. Objective light-intensity physical activity associations with rated health in older adults. Am J Epidemiol. 2010 Nov 15;172(10):1155-65. doi: 10.1093/aje/kwq249. Epub 2010 Sep 15.
PMID: 20843864
citation: Gerdhem P, Dencker M, Ringsberg K, Akesson K. Accelerometer-measured daily physical activity among octogenerians: results and associations to other indices of physical performance and bone density. Eur J Appl Physiol. 2008 Jan;102(2):173-80. doi: 10.1007/s00421-007-0571-z. Epub 2007 Sep 29. Erratum In: Eur J Appl Physiol. 2008 Apr;102(6):747.
PMID: 17906874
citation: Matthews CE, Ainsworth BE, Thompson RW, Bassett DR Jr. Sources of variance in daily physical activity levels as measured by an accelerometer. Med Sci Sports Exerc. 2002 Aug;34(8):1376-81. doi: 10.1097/00005768-200208000-00021.
PMID: 12165695
citation: Hughes DA. Feasibility, validity and reliability of the Welsh version of the EQ-5D health status questionnaire. Qual Life Res. 2007 Oct;16(8):1419-23. doi: 10.1007/s11136-007-9238-9. Epub 2007 Jul 25.
PMID: 17653613
responsible party type: Sponsor
mesh term: Fractures, Bone
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Small sample size and short study duration. Use of accelerometers to objectively capture physical activity (not all activity is captured by the accelerometers) and use of self-report physical activity logs. Possible self motivated participants.
point of contact: 