<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/NCT03289546</url>
  </required_header>
  <id_info>
    <org_study_id>201602917</org_study_id>
    <nct_id>NCT03289546</nct_id>
  </id_info>
  <brief_title>The Active Mind Study</brief_title>
  <official_title>Exploring Synergistic Effects Of Aerobic Exercise And Mindfulness Training On Cognitive Function In Older Adults: A Pilot, Proof Of Concept Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Miriam Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Miriam Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The purpose of this study is to explore whether physical exercise, mindfulness training, or&#xD;
      both interventions together can improve cognitive function in individuals with multiple risk&#xD;
      factors for the development of dementia in the future.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will test the feasibility and acceptability of a combined mindfulness&#xD;
      training + aerobic training intervention, vs. either alone or none to improve cognitive&#xD;
      function in older adults with cognitive impairment. The investigators will also obtain&#xD;
      estimates of effect sizes (and confidence intervals) on cognitive function. Preliminary&#xD;
      analyses will be conducted to explore the mediating role of changes in aerobic capacity,&#xD;
      physical activity, vascular risk factors, and mindfulness skills. Assessments will be&#xD;
      conducted at baseline, 3-, and 6- months since baseline.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2016</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">November 30, 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>Factorial Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Retention rates of 80% at the final follow-up visit</measure>
    <time_frame>3 months from baseline</time_frame>
    <description>The investigators will consider the study feasible under this condition</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants who attended at least 70% of the planned sessions</measure>
    <time_frame>3 months from baseline</time_frame>
    <description>The investigators will consider the study feasible under this condition</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants who completed 70% of the assigned individual home practice exercises</measure>
    <time_frame>3 months from baseline</time_frame>
    <description>The investigators will consider the study feasible under this condition</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability will be assessed using a satisfaction survey</measure>
    <time_frame>3 months from baseline</time_frame>
    <description>Acceptability will be assessed using a satisfaction survey. The intervention will be considered acceptable if ≥80% of participants responds that they are at least somewhat satisfied with the intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect size on cognitive function</measure>
    <time_frame>baseline, 3, 6 months</time_frame>
    <description>Preliminary estimates of effect size of mindfulness training alone vs. aerobic training alone, both, or neither on changes from baseline cognitive function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>An exploratory outcome: Mindfulness will be assessed using the Five Facets of Mindfulness questionnaire (short form)</measure>
    <time_frame>baseline, 3, 6 months</time_frame>
    <description>Five Facets of Mindfulness questionnaire (short form) is a 12-item questionnaire that measures the five identified components of mindfulness meditation: observing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>An exploratory outcome: Depression will be assessed using the Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>baseline, 3, 6 months</time_frame>
    <description>The HADS is a self-administered questionnaire with two sub-scales (0-21) measuring anxiety and depression, with higher scores indicating greater psychological morbidity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exploratory outcome: waist-to-hip ratio</measure>
    <time_frame>baseline, 3, 6 months</time_frame>
    <description>waist-to-hip ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>An exploratory outcome: Exercise capacity will be assessed via the 6 minute walking test</measure>
    <time_frame>baseline, 3, 6 months</time_frame>
    <description>The 6 minute walking test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exploratory outcome: blood pressure</measure>
    <time_frame>baseline, 3, 6 months</time_frame>
    <description>blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>An exploratory outcome: Social support will be assessed using the Multidimensional Scale of Perceived Social Support</measure>
    <time_frame>baseline, 3, 6 months</time_frame>
    <description>A 12-item, uni-dimensional tool to measure how one perceives their social support system, including individuals sources of social support (i.e., family, friends, and significant other).</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Cognitive Impairment</condition>
  <condition>Cardiovascular Risk Factor</condition>
  <arm_group>
    <arm_group_label>Mindfulness training only</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 mindfulness training class (1 hour) every week for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aerobic training only</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 aerobic training sessions (1 hour) per week for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mindfulness + aerobic training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 aerobic training sessions + 1 mindfulness training class every week for 8 weeks, then continue with 3 aerobic training sessions/ week for 4 additional weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness training</intervention_name>
    <description>The mindfulness training protocol will include the following basic components of traditional mindfulness-based stress reduction training: 1) training in awareness of sensations (&quot;body scan&quot;); 2) training in the awareness of the sensations of breathing; 3) training in directing the attention to simple activities of daily life, and in recognizing when the attention is no longer focused on a specific object of attention; and 4) training in 'open awareness'.</description>
    <arm_group_label>Mindfulness training only</arm_group_label>
    <arm_group_label>mindfulness + aerobic training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Aerobic training</intervention_name>
    <description>Exercise sessions will be led by CPR- and exercise-certified YMCA instructors and supervised by the senior research assistant. Sessions will consist of 10 minutes of warm-up, 40 minutes of aerobic exercise (walking on a treadmill), 10 minutes of cool down and stretching. Participants will receive heart monitors at the beginning of the study and will be trained by the senior research assistant to exercise targeting heart rates at 65-75% of the age predicted max heart rate or at an intensity of 12-13 in the Borg scale of the rate of perceived exertion.</description>
    <arm_group_label>Aerobic training only</arm_group_label>
    <arm_group_label>mindfulness + aerobic training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥55&#xD;
&#xD;
          2. Being physically inactive (defined as not meeting current AHA recommendations for&#xD;
             physical activity, i.e., &lt; 150 min of moderate-intensity aerobic activity per week OR&#xD;
             &lt; 75 minutes of vigorous aerobic activity per week&#xD;
&#xD;
          3. Cognitive complaint defined as answering yes to the question &quot;do you feel that your&#xD;
             memory or thinking skills have gotten worse recently?&quot;&#xD;
&#xD;
          4. Fluency in English language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unwillingness/inability to provide informed consent&#xD;
&#xD;
          2. Contraindications to physical activity as per the participant's PCP assessment&#xD;
&#xD;
          3. Blood pressure &gt;200/110&#xD;
&#xD;
          4. Severe depressive symptoms (defined as Hospital Anxiety and Depression Scale [HADS]&#xD;
             depression subscale scores &gt;14)&#xD;
&#xD;
          5. Acute psychosis (from medical record)&#xD;
&#xD;
          6. Severe cognitive impairment (Mini-Mental State Examination [MMSE] score &lt;24)&#xD;
&#xD;
          7. Recent hospitalization (&lt; 6 weeks)&#xD;
&#xD;
          8. Current (at least once a month) mind/body practice (i.e., mindfulness meditation,&#xD;
             yoga, or tai chi)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elena Salmoirago-Blotcher, PhD, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Miriam Hospital &amp; Warren Alpert Medical School at Brown University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Miriam Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02906</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>March 23, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>February 19, 2019</last_update_submitted>
  <last_update_submitted_qc>February 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Miriam Hospital</investigator_affiliation>
    <investigator_full_name>Elena Salmoirago-Blotcher</investigator_full_name>
    <investigator_title>Assistant professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>mindfulness</keyword>
  <keyword>exercise</keyword>
  <keyword>cognitive function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</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/NCT03289546
org study id: 201602917
nct id: NCT03289546
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to explore whether physical exercise, mindfulness training, or
      both interventions together can improve cognitive function in individuals with multiple risk
      factors for the development of dementia in the future.
The investigators will test the feasibility and acceptability of a combined mindfulness
      training + aerobic training intervention, vs. either alone or none to improve cognitive
      function in older adults with cognitive impairment. The investigators will also obtain
      estimates of effect sizes (and confidence intervals) on cognitive function. Preliminary
      analyses will be conducted to explore the mediating role of changes in aerobic capacity,
      physical activity, vascular risk factors, and mindfulness skills. Assessments will be
      conducted at baseline, 3-, and 6- months since baseline.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
measure: Retention rates of 80% at the final follow-up visit
time frame: 3 months from baseline
description: The investigators will consider the study feasible under this condition
measure: Number of participants who attended at least 70% of the planned sessions
time frame: 3 months from baseline
description: The investigators will consider the study feasible under this condition
measure: Number of participants who completed 70% of the assigned individual home practice exercises
time frame: 3 months from baseline
description: The investigators will consider the study feasible under this condition
measure: Acceptability will be assessed using a satisfaction survey
time frame: 3 months from baseline
description: Acceptability will be assessed using a satisfaction survey. The intervention will be considered acceptable if ≥80% of participants responds that they are at least somewhat satisfied with the intervention.
measure: Effect size on cognitive function
time frame: baseline, 3, 6 months
description: Preliminary estimates of effect size of mindfulness training alone vs. aerobic training alone, both, or neither on changes from baseline cognitive function.
measure: An exploratory outcome: Mindfulness will be assessed using the Five Facets of Mindfulness questionnaire (short form)
time frame: baseline, 3, 6 months
description: Five Facets of Mindfulness questionnaire (short form) is a 12-item questionnaire that measures the five identified components of mindfulness meditation: observing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience.
measure: An exploratory outcome: Depression will be assessed using the Hospital Anxiety and Depression Scale (HADS)
time frame: baseline, 3, 6 months
description: The HADS is a self-administered questionnaire with two sub-scales (0-21) measuring anxiety and depression, with higher scores indicating greater psychological morbidity
measure: Exploratory outcome: waist-to-hip ratio
time frame: baseline, 3, 6 months
description: waist-to-hip ratio
measure: An exploratory outcome: Exercise capacity will be assessed via the 6 minute walking test
time frame: baseline, 3, 6 months
description: The 6 minute walking test
measure: Exploratory outcome: blood pressure
time frame: baseline, 3, 6 months
description: blood pressure
measure: An exploratory outcome: Social support will be assessed using the Multidimensional Scale of Perceived Social Support
time frame: baseline, 3, 6 months
description: A 12-item, uni-dimensional tool to measure how one perceives their social support system, including individuals sources of social support (i.e., family, friends, and significant other).
arm group label: Mindfulness training only
arm group type: Experimental
description: 1 mindfulness training class (1 hour) every week for 8 weeks.
arm group label: Aerobic training only
arm group type: Experimental
description: 3 aerobic training sessions (1 hour) per week for 12 weeks.
arm group label: mindfulness + aerobic training
arm group type: Experimental
description: 2 aerobic training sessions + 1 mindfulness training class every week for 8 weeks, then continue with 3 aerobic training sessions/ week for 4 additional weeks.
arm group label: Usual care
arm group type: No Intervention
intervention type: Behavioral
intervention name: Mindfulness training
description: The mindfulness training protocol will include the following basic components of traditional mindfulness-based stress reduction training: 1) training in awareness of sensations ("body scan"); 2) training in the awareness of the sensations of breathing; 3) training in directing the attention to simple activities of daily life, and in recognizing when the attention is no longer focused on a specific object of attention; and 4) training in 'open awareness'.
arm group label: Mindfulness training only
arm group label: mindfulness + aerobic training
intervention type: Behavioral
intervention name: Aerobic training
description: Exercise sessions will be led by CPR- and exercise-certified YMCA instructors and supervised by the senior research assistant. Sessions will consist of 10 minutes of warm-up, 40 minutes of aerobic exercise (walking on a treadmill), 10 minutes of cool down and stretching. Participants will receive heart monitors at the beginning of the study and will be trained by the senior research assistant to exercise targeting heart rates at 65-75% of the age predicted max heart rate or at an intensity of 12-13 in the Borg scale of the rate of perceived exertion.
arm group label: Aerobic training only
arm group label: mindfulness + aerobic training
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
last name: Elena Salmoirago-Blotcher, PhD, MD
role: Principal Investigator
affiliation: The Miriam Hospital & Warren Alpert Medical School at Brown University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The Miriam Hospital
investigator full name: Elena Salmoirago-Blotcher
investigator title: Assistant professor of Medicine
mesh term: Cognitive Dysfunction
sharing ipd: No