<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/NCT02980744</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00053129</org_study_id>
    <nct_id>NCT02980744</nct_id>
  </id_info>
  <brief_title>A Home-based Intervention to Reduce Sedentary Behaviour and Improve Function After Stroke</brief_title>
  <acronym>STUFFS</acronym>
  <official_title>The Feasibility of a Home-based Transition Intervention to Reduce Sedentary Behaviour and Improve Function Within the First Six Months After Stroke: STand Up Frequently From Stroke Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alberta Innovates Health Solutions</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Glenrose Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alberta</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The traditional approach to physical activity promotion in people with stroke has always&#xD;
      emphasized activities of a moderate-to-vigorous intensity (i.e. moving enough to breathe fast&#xD;
      and break a sweat). For many people with stroke who often have difficulty with walking,&#xD;
      achieving that intensity of activity is difficult. The result is that people with stroke&#xD;
      spend over 80% of their day in sedentary behaviours (too much sitting). A growing body of&#xD;
      research shows that too much sitting has negative effects on health including larger waist&#xD;
      circumference, unhealthy levels of blood glucose and insulin, heart disease, lower levels of&#xD;
      functioning, and premature death.&#xD;
&#xD;
      This project tests a new approach to activity promotion that focuses on increasing&#xD;
      light-intensity activity throughout the whole day while reducing sitting time. The new&#xD;
      intervention is titled &quot;STand Up Frequently From Stroke (STUFFS)&quot; and is aimed at increasing&#xD;
      self-confidence among people with stroke to sit less, stand up and walk around at frequent&#xD;
      intervals during the day. Studies in the general population have shown that standing up and&#xD;
      walking around frequently are beneficially associated with health indicators (lower waist&#xD;
      circumference, lower blood fat and glucose levels). Encouraging people with stroke to reduce&#xD;
      sitting and increase light-intensity activities appears feasible and sustainable and might be&#xD;
      a first step to increase their daily energy expenditure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Stroke is a leading cause of adult disability among Canadians, with about 405,000&#xD;
      individuals living with the effects of stroke and this number is expected to rise by 80% in&#xD;
      the next 20 years [1]. Guidelines on activity promotion in people with stroke emphasize the&#xD;
      attainment of 150 minutes of moderate-to-vigorous intensity activity per week [2].&#xD;
&#xD;
      Moving fast enough to 'break a sweat' is challenging for people with stroke who often have&#xD;
      mobility deficits. Stroke survivors spend over 80% of their day in sedentary behaviours (too&#xD;
      much sitting) [3-5]. Accumulating evidence indicates that sedentary behaviour has deleterious&#xD;
      effects on health, regardless of exercise levels [6]. Targeting sedentary behaviour might be&#xD;
      a feasible and sustainable way to change activity behaviour in people with stroke.&#xD;
&#xD;
      Purpose: This research aims to test the feasibility of a social cognitive theory-based&#xD;
      intervention to reduce sedentary behaviour and improve light-intensity activity (such as&#xD;
      standing and walking around frequently). The focus is on improving activity behaviour and&#xD;
      will allow a systematic and staged reduction of contact with organised hospital care.&#xD;
&#xD;
      Methodological approach: Thirty-five persons with stroke will be enrolled. Outcomes including&#xD;
      sedentary behaviour, physical activity and function will be measured at baseline (week 0),&#xD;
      post-intervention (week 9) and follow-up (week 16). Activity behaviour (i.e. time sedentary,&#xD;
      standing, and stepping) will be recorded for 7 days at each time point using activPAL&#xD;
      activity monitor, validated in people with stroke [7]. Impairment from stroke will be&#xD;
      assessed using Chedoke McMaster Stroke Assessment, which is a valid and reliable tool to&#xD;
      measure impairment after stroke [8]. Cognitive status will be assessed using Montreal&#xD;
      Cognitive Assessment scale, validated in stroke [9].&#xD;
&#xD;
      At the end of the intervention, feasibility outcomes such as reach (number enrolled / number&#xD;
      eligible), retention (% enrolled who complete study), and satisfaction (exit interviews) with&#xD;
      the program will be determined. Changes in sedentary, physical activity and functional&#xD;
      outcomes across time (weeks 0, 9 and 16) will be tested.&#xD;
&#xD;
      Intervention: For the intervention, output from baseline activity monitoring (using activPAL&#xD;
      activity monitor) will provide data on usual activity behaviour. Action plans targeting areas&#xD;
      of high sedentary behaviour throughout the day will be developed. A wrist-worn activity&#xD;
      Misfit monitor - a motivational tool that will track adherence to the intervention will be&#xD;
      used throughout the intervention period (i.e. 8 weeks). This device provides activity&#xD;
      feedback for the user in real time. A checklist will be used to address: 1) use of walking&#xD;
      aids; 2) incidence of falls; 3) review and progression of home exercise program; and 4)&#xD;
      quality of walking.&#xD;
&#xD;
      Analysis: Descriptive statistics will be used to summarize baseline data. Feasibility&#xD;
      measurements (reach, retention, and satisfaction) will be evaluated as percentages. Changes&#xD;
      in activity and functional outcomes across time (weeks 0, 9 and 16) will be tested using&#xD;
      repeated measures analysis of variance (ANOVA). All analysis will be done with STATA and&#xD;
      significance level set at P &lt; 0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2016</start_date>
  <completion_date type="Actual">January 2018</completion_date>
  <primary_completion_date type="Actual">August 2017</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>Reach</measure>
    <time_frame>Follow-up (week 16)</time_frame>
    <description>Number enrolled divided by number eligible</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Retention</measure>
    <time_frame>Follow-up (week 16)</time_frame>
    <description>Percentage of those enrolled who completed the program</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction with program</measure>
    <time_frame>Post-intervention (week 9)</time_frame>
    <description>Post-intervention interviews will be conducted to assess satisfaction with the program, participants' satisfaction as a percentage will be determined.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in sedentary time</measure>
    <time_frame>baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)</time_frame>
    <description>To assess change in accelerometer-derived sedentary time from baseline to post-intervention and follow-up periods</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in standing time</measure>
    <time_frame>baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)</time_frame>
    <description>To assess change in accelerometer-derived standing time from baseline to post-intervention and follow-up periods</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in stepping time</measure>
    <time_frame>baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)</time_frame>
    <description>To assess change in accelerometer-derived stepping time from baseline to post-intervention and follow-up periods</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in number of sit-to-stand transitions</measure>
    <time_frame>baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)</time_frame>
    <description>To assess change in accelerometer-derived number of sit-to-stand transitions from baseline to post-intervention and follow-up periods</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in resting blood pressure</measure>
    <time_frame>baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)</time_frame>
    <description>To assess change in systolic and diastolic blood pressure from baseline to post-intervention and follow-up periods</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in waist circumference</measure>
    <time_frame>baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)</time_frame>
    <description>To assess change in waist circumference from baseline to post-intervention and follow-up periods</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in gait speed</measure>
    <time_frame>baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)</time_frame>
    <description>To assess change in walking speed from baseline to post-intervention and follow-up periods</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in self-efficacy scale</measure>
    <time_frame>baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)</time_frame>
    <description>To assess change in self-efficacy using Multidimensional Self-Efficacy Scale (MSES) over time from baseline to post-intervention and follow-up periods</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality-of-Life scale</measure>
    <time_frame>baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)</time_frame>
    <description>To assess change in quality of life using Stroke Impact Scale from baseline to post-intervention and follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in lower extremity impairment</measure>
    <time_frame>baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)</time_frame>
    <description>To assess change in lower extremity impairment using Chedoke McMaster Stroke Assessment for leg and foot over time from baseline to post-intervention and follow-up periods</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cognitive scale</measure>
    <time_frame>baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)</time_frame>
    <description>To assess change in cognition using Montreal Cognitive Assessment scale from baseline to post-intervention and follow-up periods</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>STUFFS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will undergo a sedentary behaviour intervention which includes breaking up prolonged sitting by standing and walking around for 5 minutes every half-hour, standing and walking during television commercial breaks, doing 2 sets of 10 sit-to-stand transitions three times per day, and going to the kitchen to grab some drink every hour. A wrist-worn Misfit activity monitor - a motivational tool that will track adherence to the intervention will be used throughout the intervention period (i.e. 8 weeks). This device which is commercially available provides activity feedback for the user in real time.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sedentary behaviour intervention</intervention_name>
    <description>The intervention is based on socio-cognitive theory and focuses on building and increasing confidence (self-efficacy) to make a behaviour change. Output from the activity monitor (i.e. activPAL) will provide visual feedback of usual activity. Action plans targeting areas of high sedentary behaviour will be developed. A wrist-worn Misfit activity monitor is used as a self-monitoring tool throughout the intervention. This commercially available device provides activity information in real time, and sets daily targets for physical activity. A checklist will be used to address: 1) use of walking aids; 2) incidence of falls; 3) review and progression of home exercise program; and 4) quality of walking. The intervention visits will be conducted by a physical therapist.</description>
    <arm_group_label>STUFFS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ischemic or hemorrhagic stroke&#xD;
&#xD;
          -  within 1 month of discharge from hospital&#xD;
&#xD;
          -  able to stand up from a chair with or without gait aid and walk at least 5 metres&#xD;
&#xD;
          -  able to understand 2-step commands&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have other neurological problems besides stroke or medically unstable.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patricia Manns, PT, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Victor Ezeugwu, PT, MSc</last_name>
    <role>Study Director</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alberta</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2G4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Krueger H, Koot J, Hall RE, O'Callaghan C, Bayley M, Corbett D. Prevalence of Individuals Experiencing the Effects of Stroke in Canada: Trends and Projections. Stroke. 2015 Aug;46(8):2226-31. doi: 10.1161/STROKEAHA.115.009616.</citation>
    <PMID>26205371</PMID>
  </reference>
  <reference>
    <citation>Coutts SB, Wein TH, Lindsay MP, Buck B, Cote R, Ellis P, Foley N, Hill MD, Jaspers S, Jin AY, Kwiatkowski B, MacPhail C, McNamara-Morse D, McMurtry MS, Mysak T, Pipe A, Silver K, Smith EE, Gubitz G; Heart, and Stroke Foundation Canada Canadian Stroke Best Practices Advisory Committee. Canadian Stroke Best Practice Recommendations: secondary prevention of stroke guidelines, update 2014. Int J Stroke. 2015 Apr;10(3):282-91. doi: 10.1111/ijs.12439. Epub 2014 Dec 23.</citation>
    <PMID>25535808</PMID>
  </reference>
  <reference>
    <citation>Tieges Z, Mead G, Allerhand M, Duncan F, van Wijck F, Fitzsimons C, Greig C, Chastin S. Sedentary behavior in the first year after stroke: a longitudinal cohort study with objective measures. Arch Phys Med Rehabil. 2015 Jan;96(1):15-23. doi: 10.1016/j.apmr.2014.08.015. Epub 2014 Sep 16.</citation>
    <PMID>25220942</PMID>
  </reference>
  <reference>
    <citation>Rand D, Eng JJ, Tang PF, Jeng JS, Hung C. How active are people with stroke?: use of accelerometers to assess physical activity. Stroke. 2009 Jan;40(1):163-8. doi: 10.1161/STROKEAHA.108.523621. Epub 2008 Oct 23.</citation>
    <PMID>18948606</PMID>
  </reference>
  <reference>
    <citation>Paul L, Brewster S, Wyke S, Gill JM, Alexander G, Dybus A, Rafferty D. Physical activity profiles and sedentary behaviour in people following stroke: a cross-sectional study. Disabil Rehabil. 2016;38(4):362-7. doi: 10.3109/09638288.2015.1041615. Epub 2015 May 4.</citation>
    <PMID>25936730</PMID>
  </reference>
  <reference>
    <citation>Biswas A, Oh PI, Faulkner GE, Bajaj RR, Silver MA, Mitchell MS, Alter DA. Sedentary time and its association with risk for disease incidence, mortality, and hospitalization in adults: a systematic review and meta-analysis. Ann Intern Med. 2015 Jan 20;162(2):123-32. doi: 10.7326/M14-1651. Erratum In: Ann Intern Med. 2015 Sep 1;163(5):400.</citation>
    <PMID>25599350</PMID>
  </reference>
  <reference>
    <citation>Taraldsen K, Askim T, Sletvold O, Einarsen EK, Bjastad KG, Indredavik B, Helbostad JL. Evaluation of a body-worn sensor system to measure physical activity in older people with impaired function. Phys Ther. 2011 Feb;91(2):277-85. doi: 10.2522/ptj.20100159. Epub 2011 Jan 6.</citation>
    <PMID>21212377</PMID>
  </reference>
  <reference>
    <citation>Gowland C, Stratford P, Ward M, Moreland J, Torresin W, Van Hullenaar S, Sanford J, Barreca S, Vanspall B, Plews N. Measuring physical impairment and disability with the Chedoke-McMaster Stroke Assessment. Stroke. 1993 Jan;24(1):58-63. doi: 10.1161/01.str.24.1.58.</citation>
    <PMID>8418551</PMID>
  </reference>
  <reference>
    <citation>Xu Q, Cao WW, Mi JH, Yu L, Lin Y, Li YS. Brief screening for mild cognitive impairment in subcortical ischemic vascular disease: a comparison study of the Montreal Cognitive Assessment with the Mini-Mental State Examination. Eur Neurol. 2014;71(3-4):106-14. doi: 10.1159/000353988. Epub 2013 Dec 10.</citation>
    <PMID>24335198</PMID>
  </reference>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>November 25, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>February 16, 2018</last_update_submitted>
  <last_update_submitted_qc>February 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Sedentary behaviour</keyword>
  <keyword>Intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data related to activPAL sedentary and activity monitoring might be shared with supervisors and other researchers</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02980744
org study id: Pro00053129
nct id: NCT02980744
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The traditional approach to physical activity promotion in people with stroke has always
      emphasized activities of a moderate-to-vigorous intensity (i.e. moving enough to breathe fast
      and break a sweat). For many people with stroke who often have difficulty with walking,
      achieving that intensity of activity is difficult. The result is that people with stroke
      spend over 80% of their day in sedentary behaviours (too much sitting). A growing body of
      research shows that too much sitting has negative effects on health including larger waist
      circumference, unhealthy levels of blood glucose and insulin, heart disease, lower levels of
      functioning, and premature death.

      This project tests a new approach to activity promotion that focuses on increasing
      light-intensity activity throughout the whole day while reducing sitting time. The new
      intervention is titled "STand Up Frequently From Stroke (STUFFS)" and is aimed at increasing
      self-confidence among people with stroke to sit less, stand up and walk around at frequent
      intervals during the day. Studies in the general population have shown that standing up and
      walking around frequently are beneficially associated with health indicators (lower waist
      circumference, lower blood fat and glucose levels). Encouraging people with stroke to reduce
      sitting and increase light-intensity activities appears feasible and sustainable and might be
      a first step to increase their daily energy expenditure.
Background: Stroke is a leading cause of adult disability among Canadians, with about 405,000
      individuals living with the effects of stroke and this number is expected to rise by 80% in
      the next 20 years [1]. Guidelines on activity promotion in people with stroke emphasize the
      attainment of 150 minutes of moderate-to-vigorous intensity activity per week [2].

      Moving fast enough to 'break a sweat' is challenging for people with stroke who often have
      mobility deficits. Stroke survivors spend over 80% of their day in sedentary behaviours (too
      much sitting) [3-5]. Accumulating evidence indicates that sedentary behaviour has deleterious
      effects on health, regardless of exercise levels [6]. Targeting sedentary behaviour might be
      a feasible and sustainable way to change activity behaviour in people with stroke.

      Purpose: This research aims to test the feasibility of a social cognitive theory-based
      intervention to reduce sedentary behaviour and improve light-intensity activity (such as
      standing and walking around frequently). The focus is on improving activity behaviour and
      will allow a systematic and staged reduction of contact with organised hospital care.

      Methodological approach: Thirty-five persons with stroke will be enrolled. Outcomes including
      sedentary behaviour, physical activity and function will be measured at baseline (week 0),
      post-intervention (week 9) and follow-up (week 16). Activity behaviour (i.e. time sedentary,
      standing, and stepping) will be recorded for 7 days at each time point using activPAL
      activity monitor, validated in people with stroke [7]. Impairment from stroke will be
      assessed using Chedoke McMaster Stroke Assessment, which is a valid and reliable tool to
      measure impairment after stroke [8]. Cognitive status will be assessed using Montreal
      Cognitive Assessment scale, validated in stroke [9].

      At the end of the intervention, feasibility outcomes such as reach (number enrolled / number
      eligible), retention (% enrolled who complete study), and satisfaction (exit interviews) with
      the program will be determined. Changes in sedentary, physical activity and functional
      outcomes across time (weeks 0, 9 and 16) will be tested.

      Intervention: For the intervention, output from baseline activity monitoring (using activPAL
      activity monitor) will provide data on usual activity behaviour. Action plans targeting areas
      of high sedentary behaviour throughout the day will be developed. A wrist-worn activity
      Misfit monitor - a motivational tool that will track adherence to the intervention will be
      used throughout the intervention period (i.e. 8 weeks). This device provides activity
      feedback for the user in real time. A checklist will be used to address: 1) use of walking
      aids; 2) incidence of falls; 3) review and progression of home exercise program; and 4)
      quality of walking.

      Analysis: Descriptive statistics will be used to summarize baseline data. Feasibility
      measurements (reach, retention, and satisfaction) will be evaluated as percentages. Changes
      in activity and functional outcomes across time (weeks 0, 9 and 16) will be tested using
      repeated measures analysis of variance (ANOVA). All analysis will be done with STATA and
      significance level set at P < 0.05.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Reach
time frame: Follow-up (week 16)
description: Number enrolled divided by number eligible
measure: Retention
time frame: Follow-up (week 16)
description: Percentage of those enrolled who completed the program
measure: Satisfaction with program
time frame: Post-intervention (week 9)
description: Post-intervention interviews will be conducted to assess satisfaction with the program, participants' satisfaction as a percentage will be determined.
measure: Change in sedentary time
time frame: baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
description: To assess change in accelerometer-derived sedentary time from baseline to post-intervention and follow-up periods
measure: Change in standing time
time frame: baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
description: To assess change in accelerometer-derived standing time from baseline to post-intervention and follow-up periods
measure: Change in stepping time
time frame: baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
description: To assess change in accelerometer-derived stepping time from baseline to post-intervention and follow-up periods
measure: Change in number of sit-to-stand transitions
time frame: baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
description: To assess change in accelerometer-derived number of sit-to-stand transitions from baseline to post-intervention and follow-up periods
measure: Change in resting blood pressure
time frame: baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
description: To assess change in systolic and diastolic blood pressure from baseline to post-intervention and follow-up periods
measure: Change in waist circumference
time frame: baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
description: To assess change in waist circumference from baseline to post-intervention and follow-up periods
measure: Change in gait speed
time frame: baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
description: To assess change in walking speed from baseline to post-intervention and follow-up periods
measure: Change in self-efficacy scale
time frame: baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
description: To assess change in self-efficacy using Multidimensional Self-Efficacy Scale (MSES) over time from baseline to post-intervention and follow-up periods
measure: Change in Quality-of-Life scale
time frame: baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
description: To assess change in quality of life using Stroke Impact Scale from baseline to post-intervention and follow-up
measure: Change in lower extremity impairment
time frame: baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
description: To assess change in lower extremity impairment using Chedoke McMaster Stroke Assessment for leg and foot over time from baseline to post-intervention and follow-up periods
measure: Change in cognitive scale
time frame: baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
description: To assess change in cognition using Montreal Cognitive Assessment scale from baseline to post-intervention and follow-up periods
arm group label: STUFFS
arm group type: Experimental
description: Participants will undergo a sedentary behaviour intervention which includes breaking up prolonged sitting by standing and walking around for 5 minutes every half-hour, standing and walking during television commercial breaks, doing 2 sets of 10 sit-to-stand transitions three times per day, and going to the kitchen to grab some drink every hour. A wrist-worn Misfit activity monitor - a motivational tool that will track adherence to the intervention will be used throughout the intervention period (i.e. 8 weeks). This device which is commercially available provides activity feedback for the user in real time.
intervention type: Behavioral
intervention name: Sedentary behaviour intervention
description: The intervention is based on socio-cognitive theory and focuses on building and increasing confidence (self-efficacy) to make a behaviour change. Output from the activity monitor (i.e. activPAL) will provide visual feedback of usual activity. Action plans targeting areas of high sedentary behaviour will be developed. A wrist-worn Misfit activity monitor is used as a self-monitoring tool throughout the intervention. This commercially available device provides activity information in real time, and sets daily targets for physical activity. A checklist will be used to address: 1) use of walking aids; 2) incidence of falls; 3) review and progression of home exercise program; and 4) quality of walking. The intervention visits will be conducted by a physical therapist.
arm group label: STUFFS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Patricia Manns, PT, PhD
role: Principal Investigator
affiliation: University of Alberta
last name: Victor Ezeugwu, PT, MSc
role: Study Director
affiliation: University of Alberta
facility: 
country: Canada
citation: Krueger H, Koot J, Hall RE, O'Callaghan C, Bayley M, Corbett D. Prevalence of Individuals Experiencing the Effects of Stroke in Canada: Trends and Projections. Stroke. 2015 Aug;46(8):2226-31. doi: 10.1161/STROKEAHA.115.009616.
PMID: 26205371
citation: Coutts SB, Wein TH, Lindsay MP, Buck B, Cote R, Ellis P, Foley N, Hill MD, Jaspers S, Jin AY, Kwiatkowski B, MacPhail C, McNamara-Morse D, McMurtry MS, Mysak T, Pipe A, Silver K, Smith EE, Gubitz G; Heart, and Stroke Foundation Canada Canadian Stroke Best Practices Advisory Committee. Canadian Stroke Best Practice Recommendations: secondary prevention of stroke guidelines, update 2014. Int J Stroke. 2015 Apr;10(3):282-91. doi: 10.1111/ijs.12439. Epub 2014 Dec 23.
PMID: 25535808
citation: Tieges Z, Mead G, Allerhand M, Duncan F, van Wijck F, Fitzsimons C, Greig C, Chastin S. Sedentary behavior in the first year after stroke: a longitudinal cohort study with objective measures. Arch Phys Med Rehabil. 2015 Jan;96(1):15-23. doi: 10.1016/j.apmr.2014.08.015. Epub 2014 Sep 16.
PMID: 25220942
citation: Rand D, Eng JJ, Tang PF, Jeng JS, Hung C. How active are people with stroke?: use of accelerometers to assess physical activity. Stroke. 2009 Jan;40(1):163-8. doi: 10.1161/STROKEAHA.108.523621. Epub 2008 Oct 23.
PMID: 18948606
citation: Paul L, Brewster S, Wyke S, Gill JM, Alexander G, Dybus A, Rafferty D. Physical activity profiles and sedentary behaviour in people following stroke: a cross-sectional study. Disabil Rehabil. 2016;38(4):362-7. doi: 10.3109/09638288.2015.1041615. Epub 2015 May 4.
PMID: 25936730
citation: Biswas A, Oh PI, Faulkner GE, Bajaj RR, Silver MA, Mitchell MS, Alter DA. Sedentary time and its association with risk for disease incidence, mortality, and hospitalization in adults: a systematic review and meta-analysis. Ann Intern Med. 2015 Jan 20;162(2):123-32. doi: 10.7326/M14-1651. Erratum In: Ann Intern Med. 2015 Sep 1;163(5):400.
PMID: 25599350
citation: Taraldsen K, Askim T, Sletvold O, Einarsen EK, Bjastad KG, Indredavik B, Helbostad JL. Evaluation of a body-worn sensor system to measure physical activity in older people with impaired function. Phys Ther. 2011 Feb;91(2):277-85. doi: 10.2522/ptj.20100159. Epub 2011 Jan 6.
PMID: 21212377
citation: Gowland C, Stratford P, Ward M, Moreland J, Torresin W, Van Hullenaar S, Sanford J, Barreca S, Vanspall B, Plews N. Measuring physical impairment and disability with the Chedoke-McMaster Stroke Assessment. Stroke. 1993 Jan;24(1):58-63. doi: 10.1161/01.str.24.1.58.
PMID: 8418551
citation: Xu Q, Cao WW, Mi JH, Yu L, Lin Y, Li YS. Brief screening for mild cognitive impairment in subcortical ischemic vascular disease: a comparison study of the Montreal Cognitive Assessment with the Mini-Mental State Examination. Eur Neurol. 2014;71(3-4):106-14. doi: 10.1159/000353988. Epub 2013 Dec 10.
PMID: 24335198
responsible party type: Sponsor
mesh term: Stroke
sharing ipd: Yes
ipd description: Data related to activPAL sedentary and activity monitoring might be shared with supervisors and other researchers