<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/NCT03270202</url>
  </required_header>
  <id_info>
    <org_study_id>2016/2300</org_study_id>
    <nct_id>NCT03270202</nct_id>
  </id_info>
  <brief_title>Wearable Devices to Promote Physical Activity</brief_title>
  <acronym>HUNT4-PAI</acronym>
  <official_title>The HUNT 4 PAI Study: A Randomized Controlled Intervention Study Using Wearable Devices to Promote Physical Activity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norwegian University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Norwegian University of Science and Technology</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 study evaluates the effect of a new wearable device, that measures physical activity&#xD;
      level based on heart rates, on relevant health outcomes including cardiorespiratory fitness.&#xD;
      Half of participants will be instructed in using the Mio Slice wristband, while the other&#xD;
      half will be requested to follow today's recommendations for physical activity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Two critical challenges precluding the full potential of physical activity in preventive&#xD;
      healthcare are: 1) The majority of people are not sufficiently active, and 2) there is a lack&#xD;
      of large, long-term intervention studies documenting the effect of personalized activity and&#xD;
      improved health in the population. Using HUNT data an algorithm called Personal Activity&#xD;
      Intelligence (PAI) has been developed. PAI was integrated in a smartphone application and&#xD;
      user friendly wristband (Mio Slice), that measures heart rate continuously and estimates an&#xD;
      individual threshold for total physical activity (defined as 100 weekly PAI) that is&#xD;
      associated with reduced risk of cardiovascular disease and mortality. The primary aim of the&#xD;
      study is to reveal whether using the wristband will increase cardiorespiratory fitness,&#xD;
      determined by maximal oxygen uptake, after 4 months among low-fit participants. The secondary&#xD;
      aims includes the effect on reversing cardiovascular risk factors, cardiac structure and&#xD;
      function, adherence to physical activity and identification of barriers after 16 weeks and 1&#xD;
      year.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    discontinuation of financial support&#xD;
  </why_stopped>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">October 17, 2018</completion_date>
  <primary_completion_date type="Actual">October 17, 2018</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Peak oxygen uptake (VO2peak)</measure>
    <time_frame>16 weeks</time_frame>
    <description>Measured by ergospirometry during a maximal treadmill protocol to exhaustion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Peak oxygen uptake (VO2peak)</measure>
    <time_frame>1 year</time_frame>
    <description>Measured by ergospirometry during a maximal treadmill protocol to exhaustion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular risk profile (ESC Score)</measure>
    <time_frame>16 weeks</time_frame>
    <description>Measured by blood samples and clinical data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular risk profile (ESC Score)</measure>
    <time_frame>1 year</time_frame>
    <description>Measured by blood samples and clinical data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Structural and functional cardiac changes</measure>
    <time_frame>16 weeks</time_frame>
    <description>Measured by echocardiography and CT coronary angiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Structural and functional cardiac changes</measure>
    <time_frame>1 year</time_frame>
    <description>Measured by echocardiography and CT coronary angiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>16 weeks</time_frame>
    <description>Measured by questionnaire SF-36</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>1 year</time_frame>
    <description>Measured by questionnaire SF-36</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to prescribed physical activity</measure>
    <time_frame>16 weeks</time_frame>
    <description>Measured by Mio Slice</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to prescribed physical activity</measure>
    <time_frame>1 year</time_frame>
    <description>Measured by Mio Slice</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feedback from users</measure>
    <time_frame>16 weeks</time_frame>
    <description>Measured by interviews and feedback systems</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feedback from users</measure>
    <time_frame>1 year</time_frame>
    <description>Measured by interviews and feedback systems</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">175</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>PAI group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to the PAI-group will receive a wearable device (Mio Slice PAI wristband) that measure heart rate continuously and via an algorithm calculates a physical activity score called PAI. The weekly goal of 100 PAI can be reached by a combination of different intensities and durations and the participants will get continuous information about their current score and amount of activity needed to reach the goal. 100 PAI is expected to approximate current guidelines of 150 minutes of moderate intensity or 75 minutes of vigorous intensity for the average participant or somewhat less if the intensity of the chosen activity is high. Proper instruction in use of the device and App will be given both oral and written after baseline testing and randomization.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Usual care: Participants in the control group will be informed about, and encouraged to be active according to current recommendations for physical activity from the health authorities.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PAI group</intervention_name>
    <description>physical activity defined as 100 weekly PAI during 1 year&#xD;
smartphone application and a user-friendly activity wristband (Mio PAI Slice)</description>
    <arm_group_label>PAI group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <description>Participants will be informed about, and encouraged to be active according to current recommendations for physical activity from the health authorities.</description>
    <arm_group_label>PAI group</arm_group_label>
    <arm_group_label>Usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participated in HUNT 3 and HUNT 4 Fitness Study&#xD;
&#xD;
          -  VO2peak in HUNT4 in the lowest sex- and age-specific tertile.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Illness or disabilities that preclude completion of the study or make exercise&#xD;
             contraindicated&#xD;
&#xD;
          -  uncontrolled hypertension, arrhythmias or angina&#xD;
&#xD;
          -  heart failure&#xD;
&#xD;
          -  primary pulmonary hypertension&#xD;
&#xD;
          -  diagnosed dementia&#xD;
&#xD;
          -  chronic communicable infectious diseases&#xD;
&#xD;
          -  participation in conflicting interventions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>23 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Øystein Risa, phd</last_name>
    <role>Study Director</role>
    <affiliation>Norwegian University of Science and Technology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bjarne Martens Nes, phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Norwegian University of Science and Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Circulation and Medical Imaging</name>
      <address>
        <city>Trondheim</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>November 28, 2018</last_update_submitted>
  <last_update_submitted_qc>November 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Exercise</keyword>
  <keyword>Cardiorespiratory fitness</keyword>
  <keyword>Risk factors</keyword>
  <keyword>Monitoring, physiologic</keyword>
  <keyword>Monitoring, ambulatory</keyword>
  <keyword>Prognosis</keyword>
  <keyword>Norway</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>After the study ends all data from baseline and follow-up testing will be transferred to HUNT databank and made available for other researchers.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Data will be available within 6 months after study completion with no time-frame restriction.</ipd_time_frame>
    <ipd_access_criteria>Data will be available for national and international institutions after contract with HUNT Research Center and includes a fee.</ipd_access_criteria>
  </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/NCT03270202
org study id: 2016/2300
nct id: NCT03270202
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the effect of a new wearable device, that measures physical activity
      level based on heart rates, on relevant health outcomes including cardiorespiratory fitness.
      Half of participants will be instructed in using the Mio Slice wristband, while the other
      half will be requested to follow today's recommendations for physical activity.
Two critical challenges precluding the full potential of physical activity in preventive
      healthcare are: 1) The majority of people are not sufficiently active, and 2) there is a lack
      of large, long-term intervention studies documenting the effect of personalized activity and
      improved health in the population. Using HUNT data an algorithm called Personal Activity
      Intelligence (PAI) has been developed. PAI was integrated in a smartphone application and
      user friendly wristband (Mio Slice), that measures heart rate continuously and estimates an
      individual threshold for total physical activity (defined as 100 weekly PAI) that is
      associated with reduced risk of cardiovascular disease and mortality. The primary aim of the
      study is to reveal whether using the wristband will increase cardiorespiratory fitness,
      determined by maximal oxygen uptake, after 4 months among low-fit participants. The secondary
      aims includes the effect on reversing cardiovascular risk factors, cardiac structure and
      function, adherence to physical activity and identification of barriers after 16 weeks and 1
      year.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Peak oxygen uptake (VO2peak)
time frame: 16 weeks
description: Measured by ergospirometry during a maximal treadmill protocol to exhaustion
measure: Peak oxygen uptake (VO2peak)
time frame: 1 year
description: Measured by ergospirometry during a maximal treadmill protocol to exhaustion
measure: Cardiovascular risk profile (ESC Score)
time frame: 16 weeks
description: Measured by blood samples and clinical data
measure: Cardiovascular risk profile (ESC Score)
time frame: 1 year
description: Measured by blood samples and clinical data
measure: Structural and functional cardiac changes
time frame: 16 weeks
description: Measured by echocardiography and CT coronary angiography
measure: Structural and functional cardiac changes
time frame: 1 year
description: Measured by echocardiography and CT coronary angiography
measure: Quality of life
time frame: 16 weeks
description: Measured by questionnaire SF-36
measure: Quality of life
time frame: 1 year
description: Measured by questionnaire SF-36
measure: Adherence to prescribed physical activity
time frame: 16 weeks
description: Measured by Mio Slice
measure: Adherence to prescribed physical activity
time frame: 1 year
description: Measured by Mio Slice
measure: Feedback from users
time frame: 16 weeks
description: Measured by interviews and feedback systems
measure: Feedback from users
time frame: 1 year
description: Measured by interviews and feedback systems
arm group label: PAI group
arm group type: Experimental
description: Participants randomized to the PAI-group will receive a wearable device (Mio Slice PAI wristband) that measure heart rate continuously and via an algorithm calculates a physical activity score called PAI. The weekly goal of 100 PAI can be reached by a combination of different intensities and durations and the participants will get continuous information about their current score and amount of activity needed to reach the goal. 100 PAI is expected to approximate current guidelines of 150 minutes of moderate intensity or 75 minutes of vigorous intensity for the average participant or somewhat less if the intensity of the chosen activity is high. Proper instruction in use of the device and App will be given both oral and written after baseline testing and randomization.
arm group label: Usual care
arm group type: Active Comparator
description: Usual care: Participants in the control group will be informed about, and encouraged to be active according to current recommendations for physical activity from the health authorities.
intervention type: Behavioral
intervention name: PAI group
description: physical activity defined as 100 weekly PAI during 1 year
smartphone application and a user-friendly activity wristband (Mio PAI Slice)
arm group label: PAI group
intervention type: Behavioral
intervention name: Usual care
description: Participants will be informed about, and encouraged to be active according to current recommendations for physical activity from the health authorities.
arm group label: PAI group
arm group label: Usual care
criteria: 
gender: All
minimum age: 23 Years
maximum age: N/A
healthy volunteers: No
last name: Øystein Risa, phd
role: Study Director
affiliation: Norwegian University of Science and Technology
last name: Bjarne Martens Nes, phd
role: Principal Investigator
affiliation: Norwegian University of Science and Technology
facility: 
country: Norway
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
sharing ipd: Yes
ipd description: After the study ends all data from baseline and follow-up testing will be transferred to HUNT databank and made available for other researchers.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: Data will be available within 6 months after study completion with no time-frame restriction.
ipd access criteria: Data will be available for national and international institutions after contract with HUNT Research Center and includes a fee.