<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/NCT04507386</url>
  </required_header>
  <id_info>
    <org_study_id>Take a STAND for Health MCI</org_study_id>
    <nct_id>NCT04507386</nct_id>
  </id_info>
  <brief_title>Reducing Sedentary Time in Patients With Mild Cognitive Impairment: The Take a STAND for Health Study</brief_title>
  <official_title>Reducing Sedentary Time in Patients With Mild Cognitive Impairment: The Take a STAND for Health Study TS4H-MCI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</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 research program aims to comprehensively investigate the clinical, physiological,&#xD;
      metabolic, and molecular effects of reducing sedentary behavior in patients with mild&#xD;
      cognitive impairment. A 4-month parallel-group randomized controlled trial will be conducted&#xD;
      aiming to investigate the feasibility and efficacy of a newly developed personalized&#xD;
      intervention focused on replacing sedentary time with light-(or very light-) intensity&#xD;
      physical activity in patients with mild cognitive impairment. Additionally, a sub-sample of&#xD;
      patients will complete a randomised cross-over study aiming to unravel potential mechanisms&#xD;
      underlying the metabolic, physiological and molecular effects of breaking up sedentary time&#xD;
      with light-intensity physical activity versus carrying out the minimum amount of daily&#xD;
      exercise at once and then remaining sedentary versus simply remaining sedentary throughout&#xD;
      all sessions, in a well-controlled laboratorial condition.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">August 2020</start_date>
  <completion_date type="Anticipated">August 2024</completion_date>
  <primary_completion_date type="Anticipated">August 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 4-month parallel-group randomised controlled trial will be performed, in which patients with mild cognitive impairment will be assessed at baseline (PRE) and after 4 months (POST). Moreover, a sub-sample of patients will perform a randomised crossover trial at baseline (PRE). Patients will complete three experimental sessions in a random manner, as follows: Prolonged sitting (SIT), in which participants engaged in prolonged sitting throughout an 5-h period and were instructed to minimize excessive movement; Exercise followed by prolonged sitting (EX), in which participants performed a 30-min moderate-to-vigorous exercise bout on a treadmill, subsequently, participants engaged in prolonged sitting as described for SIT; Light-intensity breaks (BR), in which participants completed a 3-min bout of light-intensity walking every 30 min of sitting throughout the experimental period.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sedentary behaviour assessed by ActivPAL™</measure>
    <time_frame>4 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physical activity levels assessed by ActiGraph GT3X®</measure>
    <time_frame>4 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive performance assessed by the Montreal Cognitive Assessment (MoCA)</measure>
    <time_frame>4 months</time_frame>
    <description>Questionnaire to be completed by the patient. Final score 0 to 30, lower scores indicate worse cognitive performance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive decline assessed by the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)</measure>
    <time_frame>4 months</time_frame>
    <description>Questionnaire to be completed by the caregiver. 26 Likert scale questions. Higher scores indicate worse cognitive performance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective memory complaints assessed by the Memory Complaint Scale (MCS)</measure>
    <time_frame>4 months</time_frame>
    <description>Questionnaire to be completed by the patient and the caregiver. Final scores classify memory complaints as absent, mild, moderate or accentuated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional impairments in activities of daily living assessed by the Functional Activities Questionnaire (FAQ)</measure>
    <time_frame>4 months</time_frame>
    <description>Questionnaire to be completed by the caregiver. Final score 0 to 30, higher scores indicate greater functional dependency</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety symptoms assessed by the Geriatric Anxiety Inventory (GAI)</measure>
    <time_frame>4 months</time_frame>
    <description>Questionnaire to be completed by the patient. Final score 0 to 20, higher scores indicate greater anxiety symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression symptoms assessed by the Geriatric Depression Scale (GDS-15)</measure>
    <time_frame>4 months</time_frame>
    <description>Questionnaire to be completed by the patient. Final score 0 to 15, higher scores indicate greater depression symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurocognitive assessment assessed by the Cogstate Research™ (Cogstate, Melbourne, AUS)</measure>
    <time_frame>4 months</time_frame>
    <description>Reliable online system that assesses verbal learning capacity, executive function, processing speed, attention capacity, reaction time, and operational memory. Final score will be generated automatically by the system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Magnetic resonance imaging using the Philips ACHIEVA 3.0 Tesla</measure>
    <time_frame>4 months</time_frame>
    <description>The following sequences will be obtained: 1 - sagittal 3D T1; 2 - axial T2 fast spin echo (FSE); 3 - axial fluid-attenuated inversion recovery (FLAIR); 4 - coronal T2 spectral presaturation with inversion recovery (SPIR); 5 - coronal T2 aligned with hippocampus; 6 - SENSE diffusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positron emission computed tomography with 18F-fluordesoxyglucose (PET-18FDG) using the Biograph, CTI/Siemens, Knowville, EUA</measure>
    <time_frame>4 months</time_frame>
    <description>Tomographic sections will be acquired for 15 minutes with a 256x256 matrix, zoom 2.5, resulting in pixels of size 1.04 mm (voxel of 1.04 mm3). The images will be reconstructed using the ordered subset expectation maximization (OSEM) iterative method, with six iterations and 16 subsets, and smoothed with a 5 mm Gaussian filter. The data will be corrected for scattering, attenuation and decay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of cerebrovascular reactivity to CO2 inhalation</measure>
    <time_frame>4 months</time_frame>
    <description>Patients will wear a mask connected to a unidirectional valve with a Douglas bag (with 5% CO2). Evaluations will include: partial pressure of carbon dioxide at the end of expiration (PetO2, PetCO2) (Metalyzer model III b/breath-by-breath, CORTEX, Germany) and O2 saturation (SpO2; Nellcor, Medtronic Corporation, USA). Blood flow and diameter of the internal carotid artery will be assessed using a Doppler ultrasound (Logiq E, General Electric, Milwaukee, USA) connected to a linear transducer (12L-RS - 5.0-13.0 MHz). Cerebrovascular reactivity will be assessed by responses of arterial diameter, blood flow and shear rate to CO2 inhalation (reactivity = peak - baseline). A software with automatic detection of the artery walls will be used (Cardiovascular Suite, Quipu®, Pisa, Italy). Blood flow will be calculated (Flow = Vm x πr2 x 60). The shear rate will be calculated using the following formula: Shear rate = 8 x Vm / diameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle functional assessed by the Timed Stands Test and the Timed Up-and-Go Test</measure>
    <time_frame>4 months</time_frame>
    <description>Test results will be combined to report muscle function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Handgrip strength assessed by a hand dynamometer</measure>
    <time_frame>4 months</time_frame>
    <description>Patient will have three 5-second trials, with 1-minute interval between trials. Best score will be considered handgrip strength</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>4 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue severity assessed by the Fatigue Severity Scale (FSS)</measure>
    <time_frame>4 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical and mental aspects of fatigue assessed by the Chalder Fatigue Scale (CFS)</measure>
    <time_frame>4 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI)</measure>
    <time_frame>4 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS)</measure>
    <time_frame>4 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessed by the SF-36 (Medical Outcomes Study 36 - Short-Form Health Survey)</measure>
    <time_frame>4 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Food consumption</measure>
    <time_frame>4 months</time_frame>
    <description>24-hour dietary recalls</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin sensitivity</measure>
    <time_frame>4 months</time_frame>
    <description>Fasting serum concentrations of glucose, insulin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipid profile</measure>
    <time_frame>4 months</time_frame>
    <description>Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory cytokines</measure>
    <time_frame>4 months</time_frame>
    <description>pro- and anti-inflammatory cytokines: IL-1, IL-1ra, IL-6, IL-10 e TNF-alpha</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Genetic profile for Alzheimer's disease</measure>
    <time_frame>4 months</time_frame>
    <description>Genotyping of apolipoprotein E (ApoE)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oral glucose tolerance test</measure>
    <time_frame>4 months</time_frame>
    <description>Fasting, 30, 60, 90, and 120 minutes</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Mild Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>Take a STAND for health</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A newly developed personalized intervention focused on replacing sedentary time with light-(or very light-) intensity physical activity</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will receive regular medical care and advice on healthy lifestyle, including physical activity and healthy eating recommendations</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Take a STAND for health</intervention_name>
    <description>The Take a STAND for health is a newly developed 4-month goal-setting intervention aimed at reducing sedentary behavior</description>
    <arm_group_label>Take a STAND for health</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Middle-aged and older adults with mild cognitive impairment confirmed by a team of&#xD;
             neurologists from the CEREDIC HC-FMUSP&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who spend less than 8 hours per day in sedentary time&#xD;
&#xD;
          -  Patients who are physically active (more than 150 min/week of moderate physical&#xD;
             activity, or more than 75 min/week of vigorous activity)&#xD;
&#xD;
          -  Patients who are functional illiterates&#xD;
&#xD;
          -  Patients with history or clinical diagnosis of neurological diseases&#xD;
&#xD;
          -  Patients with severe psychiatric symptoms&#xD;
&#xD;
          -  Patients taking antidepressants&#xD;
&#xD;
          -  Patients with visual and/or hearing impairments that prevent participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>August 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2020</study_first_posted>
  <last_update_submitted>August 13, 2020</last_update_submitted>
  <last_update_submitted_qc>August 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Bruno Gualano</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <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/NCT04507386
org study id: Take a STAND for Health MCI
nct id: NCT04507386
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This research program aims to comprehensively investigate the clinical, physiological,
      metabolic, and molecular effects of reducing sedentary behavior in patients with mild
      cognitive impairment. A 4-month parallel-group randomized controlled trial will be conducted
      aiming to investigate the feasibility and efficacy of a newly developed personalized
      intervention focused on replacing sedentary time with light-(or very light-) intensity
      physical activity in patients with mild cognitive impairment. Additionally, a sub-sample of
      patients will complete a randomised cross-over study aiming to unravel potential mechanisms
      underlying the metabolic, physiological and molecular effects of breaking up sedentary time
      with light-intensity physical activity versus carrying out the minimum amount of daily
      exercise at once and then remaining sedentary versus simply remaining sedentary throughout
      all sessions, in a well-controlled laboratorial condition.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A 4-month parallel-group randomised controlled trial will be performed, in which patients with mild cognitive impairment will be assessed at baseline (PRE) and after 4 months (POST). Moreover, a sub-sample of patients will perform a randomised crossover trial at baseline (PRE). Patients will complete three experimental sessions in a random manner, as follows: Prolonged sitting (SIT), in which participants engaged in prolonged sitting throughout an 5-h period and were instructed to minimize excessive movement; Exercise followed by prolonged sitting (EX), in which participants performed a 30-min moderate-to-vigorous exercise bout on a treadmill, subsequently, participants engaged in prolonged sitting as described for SIT; Light-intensity breaks (BR), in which participants completed a 3-min bout of light-intensity walking every 30 min of sitting throughout the experimental period.
primary purpose: Treatment
masking: None (Open Label)
measure: Sedentary behaviour assessed by ActivPAL™
time frame: 4 months
measure: Physical activity levels assessed by ActiGraph GT3X®
time frame: 4 months
measure: Cognitive performance assessed by the Montreal Cognitive Assessment (MoCA)
time frame: 4 months
description: Questionnaire to be completed by the patient. Final score 0 to 30, lower scores indicate worse cognitive performance
measure: Cognitive decline assessed by the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)
time frame: 4 months
description: Questionnaire to be completed by the caregiver. 26 Likert scale questions. Higher scores indicate worse cognitive performance
measure: Subjective memory complaints assessed by the Memory Complaint Scale (MCS)
time frame: 4 months
description: Questionnaire to be completed by the patient and the caregiver. Final scores classify memory complaints as absent, mild, moderate or accentuated
measure: Functional impairments in activities of daily living assessed by the Functional Activities Questionnaire (FAQ)
time frame: 4 months
description: Questionnaire to be completed by the caregiver. Final score 0 to 30, higher scores indicate greater functional dependency
measure: Anxiety symptoms assessed by the Geriatric Anxiety Inventory (GAI)
time frame: 4 months
description: Questionnaire to be completed by the patient. Final score 0 to 20, higher scores indicate greater anxiety symptoms
measure: Depression symptoms assessed by the Geriatric Depression Scale (GDS-15)
time frame: 4 months
description: Questionnaire to be completed by the patient. Final score 0 to 15, higher scores indicate greater depression symptoms
measure: Neurocognitive assessment assessed by the Cogstate Research™ (Cogstate, Melbourne, AUS)
time frame: 4 months
description: Reliable online system that assesses verbal learning capacity, executive function, processing speed, attention capacity, reaction time, and operational memory. Final score will be generated automatically by the system
measure: Magnetic resonance imaging using the Philips ACHIEVA 3.0 Tesla
time frame: 4 months
description: The following sequences will be obtained: 1 - sagittal 3D T1; 2 - axial T2 fast spin echo (FSE); 3 - axial fluid-attenuated inversion recovery (FLAIR); 4 - coronal T2 spectral presaturation with inversion recovery (SPIR); 5 - coronal T2 aligned with hippocampus; 6 - SENSE diffusion
measure: Positron emission computed tomography with 18F-fluordesoxyglucose (PET-18FDG) using the Biograph, CTI/Siemens, Knowville, EUA
time frame: 4 months
description: Tomographic sections will be acquired for 15 minutes with a 256x256 matrix, zoom 2.5, resulting in pixels of size 1.04 mm (voxel of 1.04 mm3). The images will be reconstructed using the ordered subset expectation maximization (OSEM) iterative method, with six iterations and 16 subsets, and smoothed with a 5 mm Gaussian filter. The data will be corrected for scattering, attenuation and decay
measure: Assessment of cerebrovascular reactivity to CO2 inhalation
time frame: 4 months
description: Patients will wear a mask connected to a unidirectional valve with a Douglas bag (with 5% CO2). Evaluations will include: partial pressure of carbon dioxide at the end of expiration (PetO2, PetCO2) (Metalyzer model III b/breath-by-breath, CORTEX, Germany) and O2 saturation (SpO2; Nellcor, Medtronic Corporation, USA). Blood flow and diameter of the internal carotid artery will be assessed using a Doppler ultrasound (Logiq E, General Electric, Milwaukee, USA) connected to a linear transducer (12L-RS - 5.0-13.0 MHz). Cerebrovascular reactivity will be assessed by responses of arterial diameter, blood flow and shear rate to CO2 inhalation (reactivity = peak - baseline). A software with automatic detection of the artery walls will be used (Cardiovascular Suite, Quipu®, Pisa, Italy). Blood flow will be calculated (Flow = Vm x πr2 x 60). The shear rate will be calculated using the following formula: Shear rate = 8 x Vm / diameter
measure: Muscle functional assessed by the Timed Stands Test and the Timed Up-and-Go Test
time frame: 4 months
description: Test results will be combined to report muscle function
measure: Handgrip strength assessed by a hand dynamometer
time frame: 4 months
description: Patient will have three 5-second trials, with 1-minute interval between trials. Best score will be considered handgrip strength
measure: Blood pressure
time frame: 4 months
measure: Fatigue severity assessed by the Fatigue Severity Scale (FSS)
time frame: 4 months
measure: Physical and mental aspects of fatigue assessed by the Chalder Fatigue Scale (CFS)
time frame: 4 months
measure: Subjective sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI)
time frame: 4 months
measure: Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS)
time frame: 4 months
measure: Quality of life assessed by the SF-36 (Medical Outcomes Study 36 - Short-Form Health Survey)
time frame: 4 months
measure: Food consumption
time frame: 4 months
description: 24-hour dietary recalls
measure: Insulin sensitivity
time frame: 4 months
description: Fasting serum concentrations of glucose, insulin
measure: Lipid profile
time frame: 4 months
description: Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides
measure: Inflammatory cytokines
time frame: 4 months
description: pro- and anti-inflammatory cytokines: IL-1, IL-1ra, IL-6, IL-10 e TNF-alpha
measure: Genetic profile for Alzheimer's disease
time frame: 4 months
description: Genotyping of apolipoprotein E (ApoE)
measure: Oral glucose tolerance test
time frame: 4 months
description: Fasting, 30, 60, 90, and 120 minutes
arm group label: Take a STAND for health
arm group type: Experimental
description: A newly developed personalized intervention focused on replacing sedentary time with light-(or very light-) intensity physical activity
arm group label: Control
arm group type: No Intervention
description: The control group will receive regular medical care and advice on healthy lifestyle, including physical activity and healthy eating recommendations
intervention type: Behavioral
intervention name: Take a STAND for health
description: The Take a STAND for health is a newly developed 4-month goal-setting intervention aimed at reducing sedentary behavior
arm group label: Take a STAND for health
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Bruno Gualano
investigator title: Professor
mesh term: Cognitive Dysfunction
sharing ipd: No