<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/NCT04410055</url>
  </required_header>
  <id_info>
    <org_study_id>STAND</org_study_id>
    <nct_id>NCT04410055</nct_id>
  </id_info>
  <brief_title>Non-exercise Physical Activity Intervention</brief_title>
  <acronym>STAND</acronym>
  <official_title>Effects of Dynamic Standing vs. Static Standing on Subjective Fatigue Symptoms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Science and Research Centre Koper</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Science and Research Centre Koper</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>
      Physical inactivity is prevalent in older adults and poses a risk factor for the development&#xD;
      of type 2 diabetes. The aim of this pilot study was to examine the effect of non-exercise&#xD;
      physical activity using a standing desk on clinical variables in older adults with type 2&#xD;
      diabetes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 8, 2012</start_date>
  <completion_date type="Anticipated">January 8, 2022</completion_date>
  <primary_completion_date type="Anticipated">January 8, 2022</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Oxygen consumption</measure>
    <time_frame>change in oxygen consumption between all three conditions, which will be measured with a minimum washout period of 3 days</time_frame>
    <description>Oxygen uptake VO2 (ml/min/kg)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Executive control</measure>
    <time_frame>change in executive control and cognitive switching levels between all three conditions, which will be measured with a minimum washout period of 3 days</time_frame>
    <description>Executive functions measured with Trail Making Test (seconds)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attention levels</measure>
    <time_frame>change in attentional levels between all three conditions, which will be measured with a minimum washout period of 3 days</time_frame>
    <description>Measuring attention with Stroop test (seconds)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Diabete Mellitus</condition>
  <condition>Aging</condition>
  <condition>Cognitive Change</condition>
  <arm_group>
    <arm_group_label>Sitting</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Three hours of sitting condition with ad-libitum breaks for toilet use and stretching. During this condition all cognitive, motor and pain scales were monitored.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Static standing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Four hours of static standing condition with ad-libitum breaks for toilet use and stretching. During this condition all cognitive, motor and pain scales were monitored.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dynamic standing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Four hours of dynamic standing condition with ad-libitum breaks for toilet use and stretching. During this condition all cognitive, motor and pain scales were monitored.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sitting</intervention_name>
    <description>We proposed a dynamic standing approach (working while standing accompanied by small periodic stepping movements) as a more tolerable and thereby more applicative lifestyle modification. To evaluate this form on healthy subjects, three different conditions were applied: 3 hours of sitting, static standing and dynamic standing. Both standing conditions were done with height-adjustable table which was developed at the University of Michigan (Ann Arbor, Michigan, USA)</description>
    <arm_group_label>Sitting</arm_group_label>
    <other_name>SIT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Static standing</intervention_name>
    <description>We proposed a dynamic standing approach (working while standing accompanied by small periodic stepping movements) as a more tolerable and thereby more applicative lifestyle modification. To evaluate this form on healthy subjects, three different conditions were applied: 3 hours of sitting, static standing and dynamic standing. Both standing conditions were done with height-adjustable table which was developed at the University of Michigan (Ann Arbor, Michigan, USA)</description>
    <arm_group_label>Static standing</arm_group_label>
    <other_name>STAT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Dynamic standing</intervention_name>
    <description>We proposed a dynamic standing approach (working while standing accompanied by small periodic stepping movements) as a more tolerable and thereby more applicative lifestyle modification. To evaluate this form on healthy subjects, three different conditions were applied: 3 hours of sitting, static standing and dynamic standing. Both standing conditions were done with height-adjustable table which was developed at the University of Michigan (Ann Arbor, Michigan, USA)</description>
    <arm_group_label>Dynamic standing</arm_group_label>
    <other_name>DYN</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  older participants (65+ years) with clinically confirmed type 2 diabetes&#xD;
&#xD;
          -  Body mass index above 25 and less than 40 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  participants unable to perform a short clinical and motor function test battery (sABC&#xD;
             test, Mini-BEST)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Nicolaas Bohnen, MD, PhD</last_name>
    <email>nbohnen@med.umich.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Martijn Muller, PhD</last_name>
      <phone>734-998-8400</phone>
      <email>mtmuller@umich.edu</email>
    </contact>
    <contact_backup>
      <last_name>Nico Bohnen, MD, PhD</last_name>
      <phone>+1734-998-8400</phone>
      <email>nbohnen@umich.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Dempsey PC, Larsen RN, Sethi P, Sacre JW, Straznicky NE, Cohen ND, Cerin E, Lambert GW, Owen N, Kingwell BA, Dunstan DW. Benefits for Type 2 Diabetes of Interrupting Prolonged Sitting With Brief Bouts of Light Walking or Simple Resistance Activities. Diabetes Care. 2016 Jun;39(6):964-72. doi: 10.2337/dc15-2336. Epub 2016 Apr 13.</citation>
    <PMID>27208318</PMID>
  </reference>
  <reference>
    <citation>Wheeler MJ, Green DJ, Ellis KA, Cerin E, Heinonen I, Naylor LH, Larsen R, Wennberg P, Boraxbekk CJ, Lewis J, Eikelis N, Lautenschlager NT, Kingwell BA, Lambert G, Owen N, Dunstan DW. Distinct effects of acute exercise and breaks in sitting on working memory and executive function in older adults: a three-arm, randomised cross-over trial to evaluate the effects of exercise with and without breaks in sitting on cognition. Br J Sports Med. 2020 Jul;54(13):776-781. doi: 10.1136/bjsports-2018-100168. Epub 2019 Apr 29.</citation>
    <PMID>31036563</PMID>
  </reference>
  <reference>
    <citation>Sui W, Smith ST, Fagan MJ, Rollo S, Prapavessis H. The effects of sedentary behaviour interventions on work-related productivity and performance outcomes in real and simulated office work: A systematic review. Appl Ergon. 2019 Feb;75:27-73. doi: 10.1016/j.apergo.2018.09.002. Epub 2018 Sep 18.</citation>
    <PMID>30509536</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 23, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>May 27, 2020</last_update_submitted>
  <last_update_submitted_qc>May 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04410055
org study id: STAND
nct id: NCT04410055
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Physical inactivity is prevalent in older adults and poses a risk factor for the development
      of type 2 diabetes. The aim of this pilot study was to examine the effect of non-exercise
      physical activity using a standing desk on clinical variables in older adults with type 2
      diabetes.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Oxygen consumption
time frame: change in oxygen consumption between all three conditions, which will be measured with a minimum washout period of 3 days
description: Oxygen uptake VO2 (ml/min/kg)
measure: Executive control
time frame: change in executive control and cognitive switching levels between all three conditions, which will be measured with a minimum washout period of 3 days
description: Executive functions measured with Trail Making Test (seconds)
measure: Attention levels
time frame: change in attentional levels between all three conditions, which will be measured with a minimum washout period of 3 days
description: Measuring attention with Stroop test (seconds)
arm group label: Sitting
arm group type: Active Comparator
description: Three hours of sitting condition with ad-libitum breaks for toilet use and stretching. During this condition all cognitive, motor and pain scales were monitored.
arm group label: Static standing
arm group type: Active Comparator
description: Four hours of static standing condition with ad-libitum breaks for toilet use and stretching. During this condition all cognitive, motor and pain scales were monitored.
arm group label: Dynamic standing
arm group type: Active Comparator
description: Four hours of dynamic standing condition with ad-libitum breaks for toilet use and stretching. During this condition all cognitive, motor and pain scales were monitored.
intervention type: Behavioral
intervention name: Sitting
description: We proposed a dynamic standing approach (working while standing accompanied by small periodic stepping movements) as a more tolerable and thereby more applicative lifestyle modification. To evaluate this form on healthy subjects, three different conditions were applied: 3 hours of sitting, static standing and dynamic standing. Both standing conditions were done with height-adjustable table which was developed at the University of Michigan (Ann Arbor, Michigan, USA)
arm group label: Sitting
other name: SIT
intervention type: Behavioral
intervention name: Static standing
description: We proposed a dynamic standing approach (working while standing accompanied by small periodic stepping movements) as a more tolerable and thereby more applicative lifestyle modification. To evaluate this form on healthy subjects, three different conditions were applied: 3 hours of sitting, static standing and dynamic standing. Both standing conditions were done with height-adjustable table which was developed at the University of Michigan (Ann Arbor, Michigan, USA)
arm group label: Static standing
other name: STAT
intervention type: Behavioral
intervention name: Dynamic standing
description: We proposed a dynamic standing approach (working while standing accompanied by small periodic stepping movements) as a more tolerable and thereby more applicative lifestyle modification. To evaluate this form on healthy subjects, three different conditions were applied: 3 hours of sitting, static standing and dynamic standing. Both standing conditions were done with height-adjustable table which was developed at the University of Michigan (Ann Arbor, Michigan, USA)
arm group label: Dynamic standing
other name: DYN
criteria: 
gender: All
minimum age: 65 Years
maximum age: 80 Years
healthy volunteers: No
last name: Nicolaas Bohnen, MD, PhD
email: nbohnen@med.umich.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
citation: Dempsey PC, Larsen RN, Sethi P, Sacre JW, Straznicky NE, Cohen ND, Cerin E, Lambert GW, Owen N, Kingwell BA, Dunstan DW. Benefits for Type 2 Diabetes of Interrupting Prolonged Sitting With Brief Bouts of Light Walking or Simple Resistance Activities. Diabetes Care. 2016 Jun;39(6):964-72. doi: 10.2337/dc15-2336. Epub 2016 Apr 13.
PMID: 27208318
citation: Wheeler MJ, Green DJ, Ellis KA, Cerin E, Heinonen I, Naylor LH, Larsen R, Wennberg P, Boraxbekk CJ, Lewis J, Eikelis N, Lautenschlager NT, Kingwell BA, Lambert G, Owen N, Dunstan DW. Distinct effects of acute exercise and breaks in sitting on working memory and executive function in older adults: a three-arm, randomised cross-over trial to evaluate the effects of exercise with and without breaks in sitting on cognition. Br J Sports Med. 2020 Jul;54(13):776-781. doi: 10.1136/bjsports-2018-100168. Epub 2019 Apr 29.
PMID: 31036563
citation: Sui W, Smith ST, Fagan MJ, Rollo S, Prapavessis H. The effects of sedentary behaviour interventions on work-related productivity and performance outcomes in real and simulated office work: A systematic review. Appl Ergon. 2019 Feb;75:27-73. doi: 10.1016/j.apergo.2018.09.002. Epub 2018 Sep 18.
PMID: 30509536
responsible party type: Sponsor
mesh term: Diabetes Mellitus
sharing ipd: No