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/NCT06023680</url>
    </required_header>
    <id_info>
      <org_study_id>23391</org_study_id>
      <secondary_id>K01AG076967</secondary_id>
      <nct_id>NCT06023680</nct_id>
    </id_info>
    <brief_title>The Sedentary to Active Rising to Thrive (START) Trial</brief_title>
    <acronym>START</acronym>
    <official_title>The Sedentary to Active Rising to Thrive (START) Trial: A Proof-of-Concept Sedentary Behavior Reduction Program</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Johns Hopkins Bloomberg School of Public Health</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute on Aging (NIA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Johns Hopkins Bloomberg School of Public Health</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this behavioral clinical trial is to compare two different ways of becoming less&#xD;
        sedentary and more active in 60 older adults at elevated risk of becoming frail.&#xD;
  &#xD;
        The main question this project aims to answer are whether participants in each intervention&#xD;
        are able to gradually replace 30 minutes of sedentary (sitting-like) behavior with very light&#xD;
        walking over 60 days.&#xD;
  &#xD;
        There are other questions this project aims to answer that include:&#xD;
  &#xD;
          1. whether it is easier to replace sedentary behavior with one 30-minute walking bout or&#xD;
             three 10-minute walking bouts&#xD;
  &#xD;
          2. whether becoming less sedentary and more active leads to feeling better, have less&#xD;
             stress, pain, and fatigue and have more confidence in becoming more regularly active&#xD;
  &#xD;
          3. whether becoming less sedentary and more active leads to better regulation of&#xD;
             inflammation and metabolism&#xD;
  &#xD;
        Participants will be randomized into one of two sedentary reduction behavior programs; one&#xD;
        program that gradually replaces sedentary time with one 30-minute walking bout and the other&#xD;
        program that gradually replaces sedentary time with three 10-minute walking bouts in the&#xD;
        morning, afternoon, and evening. Researchers will compare both programs to see which one is&#xD;
        easier to achieve and maintain over 60 days.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Initiating and maintaining habitual physical activity is difficult for sedentary older&#xD;
        adults, particularly those encumbered by health challenges. The 2018 US Physical Activity&#xD;
        Guidelines recommends that all adults perform ≥150 minutes/week of physical activity and&#xD;
        reduce sedentary behaviors. Yet, traditional approaches to increase physical activity do&#xD;
        little to address sedentary behavior reduction, especially for older adults. Lower sedentary&#xD;
        behavior is associated with improved biological and psychosocial health-independent of&#xD;
        meeting physical activity guidelines. Thus, there remains a critical need to implement and&#xD;
        evaluate a structured way to reduce sedentary behavior as a potential pathway for habitual&#xD;
        physical activity engagement.&#xD;
  &#xD;
        This project aims to test two prescribe-able and feasible strategies to initiate and&#xD;
        incorporate sedentary behavior reduction into daily lifestyle with remote monitoring. The&#xD;
        interventions are an inexpensive and low burden approach to reduce sedentary behavior and&#xD;
        promote habitual physical activity. Moreover, accelerometer-based outcomes of sedentary&#xD;
        behavior are novel in intervention settings, particularly when measured in free-living,&#xD;
        real-world settings. Lastly, this project directly addresses a gap of successful remotely&#xD;
        deployable interventions geared to initiate and build activity into daily life by replacing&#xD;
        sedentary time among older adults.&#xD;
  &#xD;
        Aim 1. Explore the effectiveness of 2 interventions to reduce sedentary time in pre-frail&#xD;
        older adults over 2 months&#xD;
  &#xD;
        Hypothesis 1a. Each intervention will reduce objectively measured daily sedentary time from&#xD;
        baseline levels over 2 months.&#xD;
  &#xD;
        Hypothesis 1b. The continuous intervention will result in more reduction of objectively&#xD;
        measured sedentary time than the bouts intervention.&#xD;
  &#xD;
        Aim 2. Explore the dose-response relationship between sedentary time changes and&#xD;
        patient-reported outcomes that include fatigue, fatigability, anxiety, general and&#xD;
        exercise-based self-efficacy, stress, pain, and mood over 2 months&#xD;
  &#xD;
        Hypothesis 2: Decreased daily sedentary time over 2 months is associated with decreased&#xD;
        fatigue, fatigability, anxiety, stress, and pain, and increased general and exercise-based&#xD;
        self-efficacy and mood over 2 months.&#xD;
  &#xD;
        Aim 3. Explore the dose-response relationship between sedentary time changes and biomarkers&#xD;
        of frailty-related inflammation, including serum interleukin (IL-6) (pg/mL) and tumor&#xD;
        necrosis factor (TNF) -alpha receptor 1 (pg/mL) over 2 months&#xD;
  &#xD;
        Hypothesis 3. Decreased daily sedentary time is associated with decreased serum (IL-6) and&#xD;
        TNF-alpha receptor 1 over 2 months.&#xD;
  &#xD;
        Aim 4. Explore the dose-response relationship between changes in sedentary time with&#xD;
        biomarkers of glucose and lipid metabolism (glucose, insulin, total cholesterol (TC),&#xD;
        low-density lipoprotein cholesterol (LDLC), triglycerides, high-density lipoprotein&#xD;
        cholesterol (HDLC)), a cytokine marker related to frailty (Growth/Differentiation Factor-15;&#xD;
        (GDF-15), hemoglobin A1C (hbA1c), non-esterified free fatty acid, and untargeted&#xD;
        metabolomics-based markers of energy regulation.&#xD;
  &#xD;
        Hypothesis 4. Decreased daily sedentary time is associated with decreased levels of blood&#xD;
        glucose, insulin, TC, LDLC, triglycerides and increased HDLC, decreased GDF-15, decreased&#xD;
        hbA1c, decreased non-esterified free fatty acid, and lower circulating metabolites necessary&#xD;
        for energy regulation over 2 months.&#xD;
  &#xD;
        Aim 5. Explore the dose-response and diurnal relationships between changes in sedentary time&#xD;
        and interstitial glucose continuously monitored over 24 hours for 14 consecutive days using a&#xD;
        Libre Pro sensor at baseline and 2 months later&#xD;
  &#xD;
        Hypothesis 5. Decreased sedentary time is associated with decreased overall glucose and&#xD;
        different time-of-day glucose levels, coefficient of variation, % of time in glucose at&#xD;
        various ranges (e.g., ≥200, ≥180, ≥140, 70-180, 70-140, &lt;70, &lt;54 mg/dL), mean daily&#xD;
        difference, and mean amplitude of glycemic excursion) over 2 months.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">June 2027</completion_date>
    <primary_completion_date type="Anticipated">July 2025</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>Other</primary_purpose>
      <masking>Single (Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Sedentary Time</measure>
      <time_frame>Baseline, 2 months</time_frame>
      <description>Sedentary time measured with a wrist worn monitor containing an accelerometer sensor&#xD;
  This measurement is collected under a 7-day/24-hour wear protocol at baseline and again 2 months afterwards to determine the change in sedentary time before and after either intervention.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intervention Difference in the Change in Sedentary Time</measure>
      <time_frame>Baseline, 2 months</time_frame>
      <description>Comparing the 2-month change in sedentary time between the two interventions</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Physical Activity Accumulation</measure>
      <time_frame>Baseline, 2 months</time_frame>
      <description>Physical activity fragmentation (e.g., broken up activity accumulation) wrist worn monitor containing an accelerometer sensor</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Walking Ability</measure>
      <time_frame>Baseline, 2 months</time_frame>
      <description>Ability to walk measured at a usual walking pace for 400m at baseline and 2 months afterwards.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Walking Speed</measure>
      <time_frame>Baseline, 2 months</time_frame>
      <description>Walking speed measured at a usual walking pace for 4m at baseline and 2 months afterwards.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Fatigue</measure>
      <time_frame>Baseline, 2 months</time_frame>
      <description>Fatigue measured using a Fatigue Scale questionnaire measured at baseline and 2 months afterwards.&#xD;
  On the questionnaire, a score can range from 0-13 where higher scores mean higher fatigue.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Fatigability</measure>
      <time_frame>Baseline, 2 months</time_frame>
      <description>Fatigability measured using a Pittsburgh Fatigability questionnaire measured at baseline and 2 months afterwards.&#xD;
  On the questionnaire, a score can range from 0-100 where higher scores mean higher fatigability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Anxiety</measure>
      <time_frame>Baseline, 2 months</time_frame>
      <description>Anxiety measured using an Anxiety Scale questionnaire measured at baseline and 2 months afterwards.&#xD;
  On the questionnaire, a score can range from 0-20 where higher scores mean higher anxiety.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in General Self Efficacy</measure>
      <time_frame>Baseline, 2 months</time_frame>
      <description>General Self Efficacy measured using a General Self Efficacy questionnaire measured at baseline and 2 months afterwards&#xD;
  On the questionnaire, a score can range from 0-50 where higher scores mean higher general self efficacy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Exercise-based Self Efficacy</measure>
      <time_frame>Baseline, 2 months</time_frame>
      <description>Exercise-based Self Efficacy measured using an Exercise-based Self Efficacy questionnaire measured at baseline and 2 months afterwards.&#xD;
  On the questionnaire, a score can range from 0-90 where higher scores mean higher exercise-based self efficacy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Stress</measure>
      <time_frame>Baseline, 2 months</time_frame>
      <description>Stress measured using a Perceived Stress Scale questionnaire measured at baseline and 2 months afterwards.&#xD;
  On the questionnaire, a score can range from 0-70 where higher scores mean higher stress.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Pain</measure>
      <time_frame>Baseline, 2 months</time_frame>
      <description>Pain measured using a modified version of the McGill pain questionnaire measured at baseline and 2 months afterwards.&#xD;
  On the questionnaire, a score can range from 0-5 where higher scores mean greater pain.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Mood</measure>
      <time_frame>Baseline, 2 months</time_frame>
      <description>Mood measured using a Profile of Mood Status questionnaire measured at baseline and 2 months afterwards.&#xD;
  On the questionnaire, a score can range from 0-20 where higher scores mean greater mood disturbance.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Inflammation</measure>
      <time_frame>Baseline, 2 months</time_frame>
      <description>Inflammation measured from blood draws quantifying serum IL-6 (pg/mL) and TNF-alpha receptor 1 (pg/mL) at baseline and 2 months afterwards</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Blood Glucose</measure>
      <time_frame>Baseline, 2 months</time_frame>
      <description>Blood glucose measured from blood draws</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Insulin</measure>
      <time_frame>Baseline, 2 months</time_frame>
      <description>Insulin measured from blood draws</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Total Cholesterol</measure>
      <time_frame>Baseline, 2 months</time_frame>
      <description>Total cholesterol measured from blood draws</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Low-Density Lipoprotein Cholesterol</measure>
      <time_frame>Baseline, 2 months</time_frame>
      <description>Low-density lipoprotein cholesterol measured from blood draws</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in High-Density Lipoprotein Cholesterol</measure>
      <time_frame>Baseline, 2 months</time_frame>
      <description>High-density lipoprotein cholesterol measured from blood draws</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Triglycerides</measure>
      <time_frame>Baseline, 2 months</time_frame>
      <description>Triglycerides measured from blood draws</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Growth/Differentiation Factor-15</measure>
      <time_frame>Baseline, 2 months</time_frame>
      <description>Growth/Differentiation Factor-15 measured from blood draws</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Metabolites</measure>
      <time_frame>Baseline, 2 months</time_frame>
      <description>Untargeted metabolomics-based markers of energy regulation measured from blood draws</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Hemoglobin A1c</measure>
      <time_frame>Baseline, 2 months</time_frame>
      <description>Hemoglobin A1c measured from blood draws</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Non-Esterified Free Fatty Acid</measure>
      <time_frame>Baseline, 2 months</time_frame>
      <description>Non-Esterified Free Fatty Acid measured from blood draws</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Interstitial Glucose</measure>
      <time_frame>Baseline, 2 months</time_frame>
      <description>Interstitial glucose measured using a continuous glucose monitor worn 24-hours each day for 14 consecutive days at baseline and 2 months afterwards. Specific measurements include overall glucose and different time-of-day glucose levels, coefficient of variation, % of time in glucose at various ranges (e.g., ≥200, ≥180, ≥140, 70-180, 70-140, &lt;70, &lt;54 mg/dL), mean daily difference, and mean amplitude of glycemic excursion).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Sedentary Time</condition>
    <condition>Frailty</condition>
    <arm_group>
      <arm_group_label>Continuous sedentary reduction intervention</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Structured intervention to progressively replace sedentary time with one daily 30-minute light-intensity walking bout</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Bouted sedentary reduction intervention</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Structured intervention to progressively replace sedentary time with three daily 10-minute light-intensity walking bouts</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Continuous sedentary reduction intervention</intervention_name>
      <description>During Phase 1, one minute of sedentary time will be replaced with very light to light intensity walking at three different times during the day, every day for 10 days, reaching three separate 10-minute walking intervals (or bouts).&#xD;
  During Phase 2, the three 10-minute walking bouts will be gradually combined into one 30-minute bout over the course of 20 days.</description>
      <arm_group_label>Continuous sedentary reduction intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Bouted sedentary reduction intervention</intervention_name>
      <description>During Phase 1, one minute of sedentary time will be replaced with very light to light intensity walking at three different times during the day, every day for 10 days, reaching three separate 10-minute walking intervals (or bouts).&#xD;
  During Phase 2, the three 10-minute walking bouts will be maintained over the course of 20 days.</description>
      <arm_group_label>Bouted sedentary reduction intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adults aged ≥65 years&#xD;
  &#xD;
            -  Pre-frail defined as having 1-2 of the following criteria:&#xD;
  &#xD;
            -  Self-reported unintentional weight loss&#xD;
  &#xD;
            -  Self-reported fatigue&#xD;
  &#xD;
            -  Self-reported low activity&#xD;
  &#xD;
            -  Slowness measured during a 4-m walking test&#xD;
  &#xD;
            -  Weakness measured with grip strength&#xD;
  &#xD;
            -  Self-reported regular physical activity &lt;20 minutes/day&#xD;
  &#xD;
            -  Self-reported willingness to work up to walking for 30 minutes/day&#xD;
  &#xD;
            -  Self-reported ability to find a place to walk for up to 30 minutes/day&#xD;
  &#xD;
            -  Agree to all study procedures and assessments&#xD;
  &#xD;
            -  Ability to provide informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Self-reported diabetes&#xD;
  &#xD;
            -  Self-reported problems related to alcohol or drugs&#xD;
  &#xD;
            -  Self-reported inability to walk across a room&#xD;
  &#xD;
            -  Self-reported use of a walker&#xD;
  &#xD;
            -  Self-reported requirement of medical supervision when engaging in physical activity&#xD;
  &#xD;
            -  Fallen &gt;2 times in the past month&#xD;
  &#xD;
            -  Participation in another clinical trial&#xD;
  &#xD;
            -  Plan to move out of the area within 6 months&#xD;
  &#xD;
            -  Inability to provide self-transportation to study assessment visits&#xD;
  &#xD;
            -  Inability to complete a usual-paced 400m walking test within 15 minutes without&#xD;
               sitting or the help of another&#xD;
  &#xD;
            -  Uncontrolled resting hypertension (&gt;160/90 mmHg)&#xD;
  &#xD;
            -  Cognitive impairment determined using the Montreal Cognitive Assessment Test&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Amal Wanigatunga, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Johns Hopkins Blomberg School of Public Health</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Amal Wanigatunga, PhD, MPH</last_name>
      <phone>410-502-3115</phone>
      <email>awaniga1@jhu.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Meredith Dobrosielski, MS</last_name>
      <phone>410-550-3362</phone>
      <email>mdobros1@jhmi.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Bayview Medical Center</name>
        <address>
          <city>Baltimore</city>
          <state>Maryland</state>
          <zip>21224</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Meredith Dobrosielski, MS</last_name>
        <phone>410-550-3362</phone>
        <email>mdobros1@jhmi.edu</email>
      </contact>
      <contact_backup>
        <last_name>Sydney Schultz</last_name>
        <phone>443-287-4634</phone>
        <email>sschul22@jh.edu</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Physical Activity</keyword>
    <keyword>Walking</keyword>
    <keyword>Older Adults</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Frailty</mesh_term>
    </condition_browse>
    <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/NCT06023680
  org study id: 23391
  secondary id: K01AG076967
  nct id: NCT06023680
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this behavioral clinical trial is to compare two different ways of becoming less
        sedentary and more active in 60 older adults at elevated risk of becoming frail.
  
        The main question this project aims to answer are whether participants in each intervention
        are able to gradually replace 30 minutes of sedentary (sitting-like) behavior with very light
        walking over 60 days.
  
        There are other questions this project aims to answer that include:
  
          1. whether it is easier to replace sedentary behavior with one 30-minute walking bout or
             three 10-minute walking bouts
  
          2. whether becoming less sedentary and more active leads to feeling better, have less
             stress, pain, and fatigue and have more confidence in becoming more regularly active
  
          3. whether becoming less sedentary and more active leads to better regulation of
             inflammation and metabolism
  
        Participants will be randomized into one of two sedentary reduction behavior programs; one
        program that gradually replaces sedentary time with one 30-minute walking bout and the other
        program that gradually replaces sedentary time with three 10-minute walking bouts in the
        morning, afternoon, and evening. Researchers will compare both programs to see which one is
        easier to achieve and maintain over 60 days.
  Initiating and maintaining habitual physical activity is difficult for sedentary older
        adults, particularly those encumbered by health challenges. The 2018 US Physical Activity
        Guidelines recommends that all adults perform ≥150 minutes/week of physical activity and
        reduce sedentary behaviors. Yet, traditional approaches to increase physical activity do
        little to address sedentary behavior reduction, especially for older adults. Lower sedentary
        behavior is associated with improved biological and psychosocial health-independent of
        meeting physical activity guidelines. Thus, there remains a critical need to implement and
        evaluate a structured way to reduce sedentary behavior as a potential pathway for habitual
        physical activity engagement.
  
        This project aims to test two prescribe-able and feasible strategies to initiate and
        incorporate sedentary behavior reduction into daily lifestyle with remote monitoring. The
        interventions are an inexpensive and low burden approach to reduce sedentary behavior and
        promote habitual physical activity. Moreover, accelerometer-based outcomes of sedentary
        behavior are novel in intervention settings, particularly when measured in free-living,
        real-world settings. Lastly, this project directly addresses a gap of successful remotely
        deployable interventions geared to initiate and build activity into daily life by replacing
        sedentary time among older adults.
  
        Aim 1. Explore the effectiveness of 2 interventions to reduce sedentary time in pre-frail
        older adults over 2 months
  
        Hypothesis 1a. Each intervention will reduce objectively measured daily sedentary time from
        baseline levels over 2 months.
  
        Hypothesis 1b. The continuous intervention will result in more reduction of objectively
        measured sedentary time than the bouts intervention.
  
        Aim 2. Explore the dose-response relationship between sedentary time changes and
        patient-reported outcomes that include fatigue, fatigability, anxiety, general and
        exercise-based self-efficacy, stress, pain, and mood over 2 months
  
        Hypothesis 2: Decreased daily sedentary time over 2 months is associated with decreased
        fatigue, fatigability, anxiety, stress, and pain, and increased general and exercise-based
        self-efficacy and mood over 2 months.
  
        Aim 3. Explore the dose-response relationship between sedentary time changes and biomarkers
        of frailty-related inflammation, including serum interleukin (IL-6) (pg/mL) and tumor
        necrosis factor (TNF) -alpha receptor 1 (pg/mL) over 2 months
  
        Hypothesis 3. Decreased daily sedentary time is associated with decreased serum (IL-6) and
        TNF-alpha receptor 1 over 2 months.
  
        Aim 4. Explore the dose-response relationship between changes in sedentary time with
        biomarkers of glucose and lipid metabolism (glucose, insulin, total cholesterol (TC),
        low-density lipoprotein cholesterol (LDLC), triglycerides, high-density lipoprotein
        cholesterol (HDLC)), a cytokine marker related to frailty (Growth/Differentiation Factor-15;
        (GDF-15), hemoglobin A1C (hbA1c), non-esterified free fatty acid, and untargeted
        metabolomics-based markers of energy regulation.
  
        Hypothesis 4. Decreased daily sedentary time is associated with decreased levels of blood
        glucose, insulin, TC, LDLC, triglycerides and increased HDLC, decreased GDF-15, decreased
        hbA1c, decreased non-esterified free fatty acid, and lower circulating metabolites necessary
        for energy regulation over 2 months.
  
        Aim 5. Explore the dose-response and diurnal relationships between changes in sedentary time
        and interstitial glucose continuously monitored over 24 hours for 14 consecutive days using a
        Libre Pro sensor at baseline and 2 months later
  
        Hypothesis 5. Decreased sedentary time is associated with decreased overall glucose and
        different time-of-day glucose levels, coefficient of variation, % of time in glucose at
        various ranges (e.g., ≥200, ≥180, ≥140, 70-180, 70-140, <70, <54 mg/dL), mean daily
        difference, and mean amplitude of glycemic excursion) over 2 months.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Single (Investigator)
  measure: Change in Sedentary Time
  time frame: Baseline, 2 months
  description: Sedentary time measured with a wrist worn monitor containing an accelerometer sensor
  This measurement is collected under a 7-day/24-hour wear protocol at baseline and again 2 months afterwards to determine the change in sedentary time before and after either intervention.
  measure: Intervention Difference in the Change in Sedentary Time
  time frame: Baseline, 2 months
  description: Comparing the 2-month change in sedentary time between the two interventions
  measure: Change in Physical Activity Accumulation
  time frame: Baseline, 2 months
  description: Physical activity fragmentation (e.g., broken up activity accumulation) wrist worn monitor containing an accelerometer sensor
  measure: Change in Walking Ability
  time frame: Baseline, 2 months
  description: Ability to walk measured at a usual walking pace for 400m at baseline and 2 months afterwards.
  measure: Change in Walking Speed
  time frame: Baseline, 2 months
  description: Walking speed measured at a usual walking pace for 4m at baseline and 2 months afterwards.
  measure: Change in Fatigue
  time frame: Baseline, 2 months
  description: Fatigue measured using a Fatigue Scale questionnaire measured at baseline and 2 months afterwards.
  On the questionnaire, a score can range from 0-13 where higher scores mean higher fatigue.
  measure: Change in Fatigability
  time frame: Baseline, 2 months
  description: Fatigability measured using a Pittsburgh Fatigability questionnaire measured at baseline and 2 months afterwards.
  On the questionnaire, a score can range from 0-100 where higher scores mean higher fatigability.
  measure: Change in Anxiety
  time frame: Baseline, 2 months
  description: Anxiety measured using an Anxiety Scale questionnaire measured at baseline and 2 months afterwards.
  On the questionnaire, a score can range from 0-20 where higher scores mean higher anxiety.
  measure: Change in General Self Efficacy
  time frame: Baseline, 2 months
  description: General Self Efficacy measured using a General Self Efficacy questionnaire measured at baseline and 2 months afterwards
  On the questionnaire, a score can range from 0-50 where higher scores mean higher general self efficacy.
  measure: Change in Exercise-based Self Efficacy
  time frame: Baseline, 2 months
  description: Exercise-based Self Efficacy measured using an Exercise-based Self Efficacy questionnaire measured at baseline and 2 months afterwards.
  On the questionnaire, a score can range from 0-90 where higher scores mean higher exercise-based self efficacy.
  measure: Change in Stress
  time frame: Baseline, 2 months
  description: Stress measured using a Perceived Stress Scale questionnaire measured at baseline and 2 months afterwards.
  On the questionnaire, a score can range from 0-70 where higher scores mean higher stress.
  measure: Change in Pain
  time frame: Baseline, 2 months
  description: Pain measured using a modified version of the McGill pain questionnaire measured at baseline and 2 months afterwards.
  On the questionnaire, a score can range from 0-5 where higher scores mean greater pain.
  measure: Change in Mood
  time frame: Baseline, 2 months
  description: Mood measured using a Profile of Mood Status questionnaire measured at baseline and 2 months afterwards.
  On the questionnaire, a score can range from 0-20 where higher scores mean greater mood disturbance.
  measure: Change in Inflammation
  time frame: Baseline, 2 months
  description: Inflammation measured from blood draws quantifying serum IL-6 (pg/mL) and TNF-alpha receptor 1 (pg/mL) at baseline and 2 months afterwards
  measure: Change in Blood Glucose
  time frame: Baseline, 2 months
  description: Blood glucose measured from blood draws
  measure: Change in Insulin
  time frame: Baseline, 2 months
  description: Insulin measured from blood draws
  measure: Change in Total Cholesterol
  time frame: Baseline, 2 months
  description: Total cholesterol measured from blood draws
  measure: Change in Low-Density Lipoprotein Cholesterol
  time frame: Baseline, 2 months
  description: Low-density lipoprotein cholesterol measured from blood draws
  measure: Change in High-Density Lipoprotein Cholesterol
  time frame: Baseline, 2 months
  description: High-density lipoprotein cholesterol measured from blood draws
  measure: Change in Triglycerides
  time frame: Baseline, 2 months
  description: Triglycerides measured from blood draws
  measure: Change in Growth/Differentiation Factor-15
  time frame: Baseline, 2 months
  description: Growth/Differentiation Factor-15 measured from blood draws
  measure: Change in Metabolites
  time frame: Baseline, 2 months
  description: Untargeted metabolomics-based markers of energy regulation measured from blood draws
  measure: Change in Hemoglobin A1c
  time frame: Baseline, 2 months
  description: Hemoglobin A1c measured from blood draws
  measure: Change in Non-Esterified Free Fatty Acid
  time frame: Baseline, 2 months
  description: Non-Esterified Free Fatty Acid measured from blood draws
  measure: Change in Interstitial Glucose
  time frame: Baseline, 2 months
  description: Interstitial glucose measured using a continuous glucose monitor worn 24-hours each day for 14 consecutive days at baseline and 2 months afterwards. Specific measurements include overall glucose and different time-of-day glucose levels, coefficient of variation, % of time in glucose at various ranges (e.g., ≥200, ≥180, ≥140, 70-180, 70-140, <70, <54 mg/dL), mean daily difference, and mean amplitude of glycemic excursion).
  arm group label: Continuous sedentary reduction intervention
  arm group type: Active Comparator
  description: Structured intervention to progressively replace sedentary time with one daily 30-minute light-intensity walking bout
  arm group label: Bouted sedentary reduction intervention
  arm group type: Active Comparator
  description: Structured intervention to progressively replace sedentary time with three daily 10-minute light-intensity walking bouts
  intervention type: Behavioral
  intervention name: Continuous sedentary reduction intervention
  description: During Phase 1, one minute of sedentary time will be replaced with very light to light intensity walking at three different times during the day, every day for 10 days, reaching three separate 10-minute walking intervals (or bouts).
  During Phase 2, the three 10-minute walking bouts will be gradually combined into one 30-minute bout over the course of 20 days.
  arm group label: Continuous sedentary reduction intervention
  intervention type: Behavioral
  intervention name: Bouted sedentary reduction intervention
  description: During Phase 1, one minute of sedentary time will be replaced with very light to light intensity walking at three different times during the day, every day for 10 days, reaching three separate 10-minute walking intervals (or bouts).
  During Phase 2, the three 10-minute walking bouts will be maintained over the course of 20 days.
  arm group label: Bouted sedentary reduction intervention
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Amal Wanigatunga, PhD
  role: Principal Investigator
  affiliation: Johns Hopkins Blomberg School of Public Health
  last name: Amal Wanigatunga, PhD, MPH
  phone: 410-502-3115
  email: awaniga1@jhu.edu
  last name: Meredith Dobrosielski, MS
  phone: 410-550-3362
  email: mdobros1@jhmi.edu
  facility: 
  contact: 
  contact backup: 
  country: United States
  responsible party type: Sponsor
  mesh term: Frailty
  sharing ipd: No