xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05970588</url>
    </required_header>
    <id_info>
      <org_study_id>2023-6694</org_study_id>
      <nct_id>NCT05970588</nct_id>
    </id_info>
    <brief_title>Standing Desk Converter &amp; Habitual Posture</brief_title>
    <official_title>Impact of a Standing Desk Converter Intervention on Habitual Posture, Cognition, and Cardiovascular Health</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Olga Theou</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Dalhousie University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This project will determine the short-term impact of a standing desk converter on: 1)&#xD;
        objectively measured physical activity and posture levels, and 2) brain (cognition) and heart&#xD;
        (blood pressure regulation) function. The main outcome is habitual activity patterns,&#xD;
        assessed by the thigh-worn inclinometer (activPAL). All participants will be equipped with an&#xD;
        activPAL and have their cardiovascular and cognitive function assessed at baseline and 4&#xD;
        weeks. Participants in the intervention group will use a standing desk converter for 4 weeks,&#xD;
        while the wait-list control group will be encouraged to maintain their regular activity&#xD;
        patterns. Researchers will compare the intervention and control groups to see if using the&#xD;
        standing desk converter will increase standing time and lower sedentary time, improve&#xD;
        cognition, and improve blood pressure regulation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background: Too much sedentary time (time spent sitting, reclining, or lying) leads to health&#xD;
        problems such as cognitive impairments or cardiovascular disease. A lot of sedentary time is&#xD;
        accumulated while working at a desk (e.g., computer work, studying, etc.). Standing desk&#xD;
        interventions have provided mixed support as to whether they can reduce habitual sedentary&#xD;
        time, with the need for more controlled interventional studies. It remains to be determined&#xD;
        if a simple standing desk converter (i.e., a height-adjusted desk that can be set on top of a&#xD;
        traditional sitting desk) increases standing time (i.e., not sedentary) and/or decreases&#xD;
        sedentary time. Worse cognitive health and higher blood pressure are linked to a greater risk&#xD;
        of chronic conditions such as dementia and cardiovascular disease, respectively. More&#xD;
        physical activity improves cognition and blood pressure regulation, but whether standing more&#xD;
        also translates to these brain and heart improvements is unclear.&#xD;
  &#xD;
        Main Objective: The goals of this project are to determine the impact of a standing desk&#xD;
        converter on: 1) objectively measured physical activity and posture levels, and 2) brain&#xD;
        (cognition) and heart (blood pressure regulation) function. It is expected that using the&#xD;
        standing desk converter will increase standing time and lower sedentary time, improve&#xD;
        cognition, and improve blood pressure regulation.&#xD;
  &#xD;
        Methodology: For the proposed project, we will assess free-living posture, cognition, and&#xD;
        blood pressure regulation before and after 4-weeks of either using a standing desk converter&#xD;
        (intervention) or a wait-list control. The study population targets adults who use a&#xD;
        traditional seated desk for a minimum of 20 hours per week and do not already use a standing&#xD;
        desk. Free-living activity will be assessed using activity monitors (activPALs) worn for&#xD;
        7-days before and after either the control period or intervention. Cognition will be assessed&#xD;
        using a computerized Stroop task that records accuracy and reaction times to selecting the&#xD;
        colour of the word or the word itself (e.g., word BLUE written in red font). Progressively&#xD;
        more challenging Stroop conditions will be used to assess different aspects of cognition.&#xD;
        During the Stroop, cerebral oxygenation will be determined using near-infrared spectroscopy.&#xD;
        Beat-by-beat blood pressure (via finger cuff), heart rate (via electrocardiogram), and&#xD;
        internal carotid artery size and red blood cell velocity (via ultrasound) will be measured&#xD;
        while lying down and in response to 20 minutes of 60-degree passive head-up tilt that tests&#xD;
        blood pressure regulation. The proposed study will yield new knowledge as it relates to&#xD;
        real-life posture interventions that promote healthier movement and investigates whether&#xD;
        standing converters lead to improvements in brain and heart health.&#xD;
  &#xD;
        Significance: The proposed study will yield new knowledge as it relates to real-life posture&#xD;
        interventions that promote healthier movement and investigates whether standing converters&#xD;
        lead to improvements in brain and heart health.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>A block randomization strategy will be implemented to ensure equal allocations to intervention/control groups in groups of 6 (3 per group). Even and odd numerals will represent designation to the Intervention and Control groups, respectively. For example, if the first 3 participants are randomized to the control group, the next 3 will be allocated to the intervention group. To ensure all control participants will be offered the intervention after their control period, the first 3 participants for the final block of 6 (block 7) will be randomized to the control group first. Randomization will occur after Visit 1 assessments are complete.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>The control group will receive no intervention and will be inherently not blinded to their group allocation. All analyses will be completed by an individual blinded to participants' group allocation.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>ActivPAL monitors</measure>
      <time_frame>Change from baseline (week 0) activity to post intervention (week 4).</time_frame>
      <description>Habitual sedentary and physical activity data will be recorded through the thigh-worn monitor. Information obtained from the 3 monitors will provide information regarding time spent lying, sitting (bent vs straight leg) and standing.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cognition</measure>
      <time_frame>Change from baseline (week 0) activity to post intervention (week 4).</time_frame>
      <description>The computerized Stroop task will consist of the three conditions mentioned above: simple, interference, and switching. The computer program used to administer the task records accuracy and reaction time.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Brain Activation: Functional Near Infrared Spectroscopy</measure>
      <time_frame>Change from baseline (week 0) activity to post intervention (week 4).</time_frame>
      <description>Functional Near Infrared Spectroscopy (fNIRS) is a well-established modality of neuroimaging that can detect differences in blood-oxygen-level dependent (BOLD) signal, allowing one to make inferences on brain activity. fNIRS sensors consist of light sources that emit near-infrared light, as well as photo diodes that detect the levels of the light at the two different frequencies. As each wavelength of light is known to be absorbed differently by oxy- and deoxyhemoglobin, one can infer cerebral oxygenation via the relative absorption of each wavelength through the application of a modified beer-lambert law. The NIRScout system contains 8 LED sources and 16 detectors (optodes), which can be placed in customized configurations to measure from different regions of the brain. The sources and detectors are held in place through an elasticized cap that fastens with Velcro under the chin.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Electrocardiography</measure>
      <time_frame>Change from baseline (week 0) activity to post intervention (week 4).</time_frame>
      <description>Heart rate will be monitored via electrocardiography (ECG). ECG is the non-invasive, passive recording of electrical cardiac activity at the surface of the skin. This will be recorded at a sampling frequency using a dedicated data acquisition system (PowerLab, ADInstruments) and analysis software (Lab Chart, ADInstruments).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Continuous Finger Blood Pressure Recording (Finapres Medical Systems)</measure>
      <time_frame>Change from baseline (week 0) activity to post intervention (week 4).</time_frame>
      <description>A small cuff used to measure continuous, non-invasive blood pressure will be placed around the middle or index finger. When in use, the cuff will inflate with air and gently squeeze the finger. This will be recorded at a sampling rate of 200Hz using a dedicated data acquisition system (PowerLab, ADInstruments) and analysis software (Lab Chart, ADInstruments).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Upper Arm Blood Pressure Measurements</measure>
      <time_frame>Change from baseline (week 0) activity to post intervention (week 4).</time_frame>
      <description>A semi-automated patient vital signs monitor (Carescape v100®, General Electric Healthcare) will be used to record resting, seated blood pressure from the upper left arm (i.e., the brachial artery). Additional measurements will be recorded during the various rest periods.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Carotid Artery Structure</measure>
      <time_frame>Change from baseline (week 0) activity to post intervention (week 4).</time_frame>
      <description>Internal carotid artery intima-media thickness will be imaged on the right-side. A minimum of two minutes of beat-by-beat carotid images during supine rest, the initial tilt, and the final tilt period will be collected.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Carotid Artery Function</measure>
      <time_frame>Change from baseline (week 0) activity to post intervention (week 4).</time_frame>
      <description>Internal carotid artery function changes in blood flow to head-up tilt will be measured via ultrasonography. A minimum of two minutes of beat-by-beat carotid images during supine rest, the initial tilt, and the final tilt period will be collected in the right-side common carotid artery.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Sedentary Time</condition>
    <condition>Cognitive Function</condition>
    <condition>Blood Pressure Regulation</condition>
    <arm_group>
      <arm_group_label>Wait-list Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Fitted with inclinometers/accelerometers at week 0 and week 4 of the intervention period for 7 consecutive days of wear. Measures of cognition and blood pressure regulation will occur at these same timepoints. Daily activities of participants will not be restricted if patients are assigned to the control group.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Intervention Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Fitted with inclinometers/accelerometers at week 0 and week 4 of the intervention period for 7 consecutive days of wear. Measures of cognition and blood pressure regulation will occur at these same timepoints.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Standing Promotion Intervention</intervention_name>
      <description>Participants will be provided with a standing desk converter to set on top of their existing desk for 4 weeks.</description>
      <arm_group_label>Intervention Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 years of age or older&#xD;
  &#xD;
            -  Are normotensive, cognitively healthy, and do not have a history of fainting while&#xD;
               standing&#xD;
  &#xD;
            -  Are able to stand for 10 min without assistance (e.g., require a walker, person&#xD;
               assistance)&#xD;
  &#xD;
            -  Are not allergic to clear medical adhesive (TegadermTM, 3M) used to secure the&#xD;
               activPAL activity monitors&#xD;
  &#xD;
            -  Use a seated desk at least 20 hours/week in the last month and do not use a standing&#xD;
               or active desk already&#xD;
  &#xD;
            -  Females who are not pregnant, breastfeeding or planning on becoming pregnant prior to&#xD;
               entry into the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Younger than 18 years old&#xD;
  &#xD;
            -  Hypertension (resting systolic pressure &gt;139 mmHg and/or diastolic pressure &gt;89 mmHg)&#xD;
  &#xD;
            -  Have a diagnosed cognitive impairment&#xD;
  &#xD;
            -  Have a history of orthostatic hypotension/intolerance and/or fainting while standing&#xD;
  &#xD;
            -  Cannot stand for at least 10 min without assistance (e.g., require a walker, person&#xD;
               assistance)&#xD;
  &#xD;
            -  Have a known allergy to the clear medical adhesive (TegadermTM, 3M)&#xD;
  &#xD;
            -  Use a seated desk less than 20 hours/week, use a standing or active desk already, or&#xD;
               use a desk for more than 20 hours/week but not in the last month&#xD;
  &#xD;
            -  Females who are pregnant, breastfeeding or planning on becoming pregnant prior to&#xD;
               entry into the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Myles W O'Brien, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Medicine and Department of Physiotherapy, Dalhousie University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Myles W O'Brien, PhD</last_name>
      <phone>902-301-2523</phone>
      <email>myles.obrien@dal.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Olga Theou, PhD</last_name>
      <phone>(902) 494-4248</phone>
      <email>olga.theou@dal.ca</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Dalhousie University</name>
        <address>
          <city>Halifax</city>
          <state>Nova Scotia</state>
          <zip>B3H 4R2</zip>
          <country>Canada</country>
        </address>
      </facility>
      <contact>
        <last_name>Myles W O'Brien, PhD</last_name>
        <phone>902-301-2523</phone>
        <email>myles.obrien@dal.ca</email>
      </contact>
      <contact_backup>
        <last_name>Olga Theou, PhD</last_name>
        <phone>(902) 494-4248</phone>
        <email>olga.theou@dal.ca</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <reference>
      <citation>Dorey TW, O'Brien MW, Robinson SA, Kimmerly DS. Knee-high compression socks minimize head-up tilt-induced cerebral and cardiovascular responses following dynamic exercise. Scand J Med Sci Sports. 2018 Jul;28(7):1766-1774. doi: 10.1111/sms.13084. Epub 2018 Apr 16.</citation>
      <PMID>29575406</PMID>
    </reference>
    <reference>
      <citation>Neuhaus M, Eakin EG, Straker L, Owen N, Dunstan DW, Reid N, Healy GN. Reducing occupational sedentary time: a systematic review and meta-analysis of evidence on activity-permissive workstations. Obes Rev. 2014 Oct;15(10):822-38. doi: 10.1111/obr.12201. Epub 2014 Jul 11.</citation>
      <PMID>25040784</PMID>
    </reference>
    <reference>
      <citation>O'Brien MW, Daley WS, Schwartz BD, Shivgulam ME, Wu Y, Kimmerly DS, Frayne RJ. Characterization of Detailed Sedentary Postures Using a Tri-Monitor ActivPAL Configuration in Free-Living Conditions. Sensors (Basel). 2023 Jan 4;23(2):587. doi: 10.3390/s23020587.</citation>
      <PMID>36679384</PMID>
    </reference>
    <reference>
      <citation>Petterson, JL, Mekari, S, O'Brien, MW. An open-source Stroop task program that incorporates a switching condition to determine executive function. Software Impacts. 2022 Jul 7 13, 100361. doi: 10.1016/j.simpa.2022.100361</citation>
    </reference>
    <reference>
      <citation>de Rezende LF, Rodrigues Lopes M, Rey-Lopez JP, Matsudo VK, Luiz Odo C. Sedentary behavior and health outcomes: an overview of systematic reviews. PLoS One. 2014 Aug 21;9(8):e105620. doi: 10.1371/journal.pone.0105620. eCollection 2014.</citation>
      <PMID>25144686</PMID>
    </reference>
    <reference>
      <citation>Thorp AA, Healy GN, Winkler E, Clark BK, Gardiner PA, Owen N, Dunstan DW. Prolonged sedentary time and physical activity in workplace and non-work contexts: a cross-sectional study of office, customer service and call centre employees. Int J Behav Nutr Phys Act. 2012 Oct 26;9:128. doi: 10.1186/1479-5868-9-128.</citation>
      <PMID>23101767</PMID>
    </reference>
    <reference>
      <citation>O'Brien MW, Kimmerly DS, Mekari S. Greater habitual moderate-to-vigorous physical activity is associated with better executive function and higher prefrontal oxygenation in older adults. Geroscience. 2021 Dec;43(6):2707-2718. doi: 10.1007/s11357-021-00391-5. Epub 2021 Jun 3.</citation>
      <PMID>34081258</PMID>
    </reference>
    <reference>
      <citation>De Vries J, Michielsen HJ, Van Heck GL. Assessment of fatigue among working people: a comparison of six questionnaires. Occup Environ Med. 2003 Jun;60 Suppl 1(Suppl 1):i10-5. doi: 10.1136/oem.60.suppl_1.i10.</citation>
      <PMID>12782741</PMID>
    </reference>
    <reference>
      <citation>Hatoum T, Sheldon R. A practical approach to investigation of syncope. Can J Cardiol. 2014 Jun;30(6):671-4. doi: 10.1016/j.cjca.2014.03.043. Epub 2014 Apr 3.</citation>
      <PMID>24882540</PMID>
    </reference>
    <reference>
      <citation>Petersen ME, Williams TR, Gordon C, Chamberlain-Webber R, Sutton R. The normal response to prolonged passive head up tilt testing. Heart. 2000 Nov;84(5):509-14. doi: 10.1136/heart.84.5.509.</citation>
      <PMID>11040011</PMID>
    </reference>
    <reference>
      <citation>Bantoft C, Summers MJ, Tranent PJ, Palmer MA, Cooley PD, Pedersen SJ. Effect of Standing or Walking at a Workstation on Cognitive Function: A Randomized Counterbalanced Trial. Hum Factors. 2016 Feb;58(1):140-9. doi: 10.1177/0018720815605446. Epub 2015 Sep 24.</citation>
      <PMID>26408647</PMID>
    </reference>
    <reference>
      <citation>E F Graves L, C Murphy R, Shepherd SO, Cabot J, Hopkins ND. Evaluation of sit-stand workstations in an office setting: a randomised controlled trial. BMC Public Health. 2015 Nov 19;15:1145. doi: 10.1186/s12889-015-2469-8.</citation>
      <PMID>26584856</PMID>
    </reference>
    <reference>
      <citation>Ma J, Ma D, Li Z, Kim H. Effects of a Workplace Sit-Stand Desk Intervention on Health and Productivity. Int J Environ Res Public Health. 2021 Nov 4;18(21):11604. doi: 10.3390/ijerph182111604.</citation>
      <PMID>34770116</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 16, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Dalhousie University</investigator_affiliation>
      <investigator_full_name>Olga Theou</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>Standing Time</keyword>
    <keyword>Occupational Health</keyword>
    <keyword>Stroop Task</keyword>
    <keyword>Carotid Intima-Media Thickness</keyword>
    <keyword>Head-Up Tilt</keyword>
    <keyword>Objectively Measured Activity</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05970588
  org study id: 2023-6694
  nct id: NCT05970588
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This project will determine the short-term impact of a standing desk converter on: 1)
        objectively measured physical activity and posture levels, and 2) brain (cognition) and heart
        (blood pressure regulation) function. The main outcome is habitual activity patterns,
        assessed by the thigh-worn inclinometer (activPAL). All participants will be equipped with an
        activPAL and have their cardiovascular and cognitive function assessed at baseline and 4
        weeks. Participants in the intervention group will use a standing desk converter for 4 weeks,
        while the wait-list control group will be encouraged to maintain their regular activity
        patterns. Researchers will compare the intervention and control groups to see if using the
        standing desk converter will increase standing time and lower sedentary time, improve
        cognition, and improve blood pressure regulation.
  Background: Too much sedentary time (time spent sitting, reclining, or lying) leads to health
        problems such as cognitive impairments or cardiovascular disease. A lot of sedentary time is
        accumulated while working at a desk (e.g., computer work, studying, etc.). Standing desk
        interventions have provided mixed support as to whether they can reduce habitual sedentary
        time, with the need for more controlled interventional studies. It remains to be determined
        if a simple standing desk converter (i.e., a height-adjusted desk that can be set on top of a
        traditional sitting desk) increases standing time (i.e., not sedentary) and/or decreases
        sedentary time. Worse cognitive health and higher blood pressure are linked to a greater risk
        of chronic conditions such as dementia and cardiovascular disease, respectively. More
        physical activity improves cognition and blood pressure regulation, but whether standing more
        also translates to these brain and heart improvements is unclear.
  
        Main Objective: The goals of this project are to determine the impact of a standing desk
        converter on: 1) objectively measured physical activity and posture levels, and 2) brain
        (cognition) and heart (blood pressure regulation) function. It is expected that using the
        standing desk converter will increase standing time and lower sedentary time, improve
        cognition, and improve blood pressure regulation.
  
        Methodology: For the proposed project, we will assess free-living posture, cognition, and
        blood pressure regulation before and after 4-weeks of either using a standing desk converter
        (intervention) or a wait-list control. The study population targets adults who use a
        traditional seated desk for a minimum of 20 hours per week and do not already use a standing
        desk. Free-living activity will be assessed using activity monitors (activPALs) worn for
        7-days before and after either the control period or intervention. Cognition will be assessed
        using a computerized Stroop task that records accuracy and reaction times to selecting the
        colour of the word or the word itself (e.g., word BLUE written in red font). Progressively
        more challenging Stroop conditions will be used to assess different aspects of cognition.
        During the Stroop, cerebral oxygenation will be determined using near-infrared spectroscopy.
        Beat-by-beat blood pressure (via finger cuff), heart rate (via electrocardiogram), and
        internal carotid artery size and red blood cell velocity (via ultrasound) will be measured
        while lying down and in response to 20 minutes of 60-degree passive head-up tilt that tests
        blood pressure regulation. The proposed study will yield new knowledge as it relates to
        real-life posture interventions that promote healthier movement and investigates whether
        standing converters lead to improvements in brain and heart health.
  
        Significance: The proposed study will yield new knowledge as it relates to real-life posture
        interventions that promote healthier movement and investigates whether standing converters
        lead to improvements in brain and heart health.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: A block randomization strategy will be implemented to ensure equal allocations to intervention/control groups in groups of 6 (3 per group). Even and odd numerals will represent designation to the Intervention and Control groups, respectively. For example, if the first 3 participants are randomized to the control group, the next 3 will be allocated to the intervention group. To ensure all control participants will be offered the intervention after their control period, the first 3 participants for the final block of 6 (block 7) will be randomized to the control group first. Randomization will occur after Visit 1 assessments are complete.
  primary purpose: Other
  masking: Single (Outcomes Assessor)
  masking description: The control group will receive no intervention and will be inherently not blinded to their group allocation. All analyses will be completed by an individual blinded to participants' group allocation.
  measure: ActivPAL monitors
  time frame: Change from baseline (week 0) activity to post intervention (week 4).
  description: Habitual sedentary and physical activity data will be recorded through the thigh-worn monitor. Information obtained from the 3 monitors will provide information regarding time spent lying, sitting (bent vs straight leg) and standing.
  measure: Cognition
  time frame: Change from baseline (week 0) activity to post intervention (week 4).
  description: The computerized Stroop task will consist of the three conditions mentioned above: simple, interference, and switching. The computer program used to administer the task records accuracy and reaction time.
  measure: Brain Activation: Functional Near Infrared Spectroscopy
  time frame: Change from baseline (week 0) activity to post intervention (week 4).
  description: Functional Near Infrared Spectroscopy (fNIRS) is a well-established modality of neuroimaging that can detect differences in blood-oxygen-level dependent (BOLD) signal, allowing one to make inferences on brain activity. fNIRS sensors consist of light sources that emit near-infrared light, as well as photo diodes that detect the levels of the light at the two different frequencies. As each wavelength of light is known to be absorbed differently by oxy- and deoxyhemoglobin, one can infer cerebral oxygenation via the relative absorption of each wavelength through the application of a modified beer-lambert law. The NIRScout system contains 8 LED sources and 16 detectors (optodes), which can be placed in customized configurations to measure from different regions of the brain. The sources and detectors are held in place through an elasticized cap that fastens with Velcro under the chin.
  measure: Electrocardiography
  time frame: Change from baseline (week 0) activity to post intervention (week 4).
  description: Heart rate will be monitored via electrocardiography (ECG). ECG is the non-invasive, passive recording of electrical cardiac activity at the surface of the skin. This will be recorded at a sampling frequency using a dedicated data acquisition system (PowerLab, ADInstruments) and analysis software (Lab Chart, ADInstruments).
  measure: Continuous Finger Blood Pressure Recording (Finapres Medical Systems)
  time frame: Change from baseline (week 0) activity to post intervention (week 4).
  description: A small cuff used to measure continuous, non-invasive blood pressure will be placed around the middle or index finger. When in use, the cuff will inflate with air and gently squeeze the finger. This will be recorded at a sampling rate of 200Hz using a dedicated data acquisition system (PowerLab, ADInstruments) and analysis software (Lab Chart, ADInstruments).
  measure: Upper Arm Blood Pressure Measurements
  time frame: Change from baseline (week 0) activity to post intervention (week 4).
  description: A semi-automated patient vital signs monitor (Carescape v100®, General Electric Healthcare) will be used to record resting, seated blood pressure from the upper left arm (i.e., the brachial artery). Additional measurements will be recorded during the various rest periods.
  measure: Carotid Artery Structure
  time frame: Change from baseline (week 0) activity to post intervention (week 4).
  description: Internal carotid artery intima-media thickness will be imaged on the right-side. A minimum of two minutes of beat-by-beat carotid images during supine rest, the initial tilt, and the final tilt period will be collected.
  measure: Carotid Artery Function
  time frame: Change from baseline (week 0) activity to post intervention (week 4).
  description: Internal carotid artery function changes in blood flow to head-up tilt will be measured via ultrasonography. A minimum of two minutes of beat-by-beat carotid images during supine rest, the initial tilt, and the final tilt period will be collected in the right-side common carotid artery.
  arm group label: Wait-list Control Group
  arm group type: No Intervention
  description: Fitted with inclinometers/accelerometers at week 0 and week 4 of the intervention period for 7 consecutive days of wear. Measures of cognition and blood pressure regulation will occur at these same timepoints. Daily activities of participants will not be restricted if patients are assigned to the control group.
  arm group label: Intervention Group
  arm group type: Experimental
  description: Fitted with inclinometers/accelerometers at week 0 and week 4 of the intervention period for 7 consecutive days of wear. Measures of cognition and blood pressure regulation will occur at these same timepoints.
  intervention type: Behavioral
  intervention name: Standing Promotion Intervention
  description: Participants will be provided with a standing desk converter to set on top of their existing desk for 4 weeks.
  arm group label: Intervention Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Myles W O'Brien, PhD
  role: Principal Investigator
  affiliation: Department of Medicine and Department of Physiotherapy, Dalhousie University
  last name: Myles W O'Brien, PhD
  phone: 902-301-2523
  email: myles.obrien@dal.ca
  last name: Olga Theou, PhD
  phone: (902) 494-4248
  email: olga.theou@dal.ca
  facility: 
  contact: 
  contact backup: 
  country: Canada
  citation: Dorey TW, O'Brien MW, Robinson SA, Kimmerly DS. Knee-high compression socks minimize head-up tilt-induced cerebral and cardiovascular responses following dynamic exercise. Scand J Med Sci Sports. 2018 Jul;28(7):1766-1774. doi: 10.1111/sms.13084. Epub 2018 Apr 16.
  PMID: 29575406
  citation: Neuhaus M, Eakin EG, Straker L, Owen N, Dunstan DW, Reid N, Healy GN. Reducing occupational sedentary time: a systematic review and meta-analysis of evidence on activity-permissive workstations. Obes Rev. 2014 Oct;15(10):822-38. doi: 10.1111/obr.12201. Epub 2014 Jul 11.
  PMID: 25040784
  citation: O'Brien MW, Daley WS, Schwartz BD, Shivgulam ME, Wu Y, Kimmerly DS, Frayne RJ. Characterization of Detailed Sedentary Postures Using a Tri-Monitor ActivPAL Configuration in Free-Living Conditions. Sensors (Basel). 2023 Jan 4;23(2):587. doi: 10.3390/s23020587.
  PMID: 36679384
  citation: Petterson, JL, Mekari, S, O'Brien, MW. An open-source Stroop task program that incorporates a switching condition to determine executive function. Software Impacts. 2022 Jul 7 13, 100361. doi: 10.1016/j.simpa.2022.100361
  citation: de Rezende LF, Rodrigues Lopes M, Rey-Lopez JP, Matsudo VK, Luiz Odo C. Sedentary behavior and health outcomes: an overview of systematic reviews. PLoS One. 2014 Aug 21;9(8):e105620. doi: 10.1371/journal.pone.0105620. eCollection 2014.
  PMID: 25144686
  citation: Thorp AA, Healy GN, Winkler E, Clark BK, Gardiner PA, Owen N, Dunstan DW. Prolonged sedentary time and physical activity in workplace and non-work contexts: a cross-sectional study of office, customer service and call centre employees. Int J Behav Nutr Phys Act. 2012 Oct 26;9:128. doi: 10.1186/1479-5868-9-128.
  PMID: 23101767
  citation: O'Brien MW, Kimmerly DS, Mekari S. Greater habitual moderate-to-vigorous physical activity is associated with better executive function and higher prefrontal oxygenation in older adults. Geroscience. 2021 Dec;43(6):2707-2718. doi: 10.1007/s11357-021-00391-5. Epub 2021 Jun 3.
  PMID: 34081258
  citation: De Vries J, Michielsen HJ, Van Heck GL. Assessment of fatigue among working people: a comparison of six questionnaires. Occup Environ Med. 2003 Jun;60 Suppl 1(Suppl 1):i10-5. doi: 10.1136/oem.60.suppl_1.i10.
  PMID: 12782741
  citation: Hatoum T, Sheldon R. A practical approach to investigation of syncope. Can J Cardiol. 2014 Jun;30(6):671-4. doi: 10.1016/j.cjca.2014.03.043. Epub 2014 Apr 3.
  PMID: 24882540
  citation: Petersen ME, Williams TR, Gordon C, Chamberlain-Webber R, Sutton R. The normal response to prolonged passive head up tilt testing. Heart. 2000 Nov;84(5):509-14. doi: 10.1136/heart.84.5.509.
  PMID: 11040011
  citation: Bantoft C, Summers MJ, Tranent PJ, Palmer MA, Cooley PD, Pedersen SJ. Effect of Standing or Walking at a Workstation on Cognitive Function: A Randomized Counterbalanced Trial. Hum Factors. 2016 Feb;58(1):140-9. doi: 10.1177/0018720815605446. Epub 2015 Sep 24.
  PMID: 26408647
  citation: E F Graves L, C Murphy R, Shepherd SO, Cabot J, Hopkins ND. Evaluation of sit-stand workstations in an office setting: a randomised controlled trial. BMC Public Health. 2015 Nov 19;15:1145. doi: 10.1186/s12889-015-2469-8.
  PMID: 26584856
  citation: Ma J, Ma D, Li Z, Kim H. Effects of a Workplace Sit-Stand Desk Intervention on Health and Productivity. Int J Environ Res Public Health. 2021 Nov 4;18(21):11604. doi: 10.3390/ijerph182111604.
  PMID: 34770116
  responsible party type: Sponsor-Investigator
  investigator affiliation: Dalhousie University
  investigator full name: Olga Theou
  investigator title: Assistant Professor
  sharing ipd: No