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Reducing Sedentary Time in Patients With Mild Cognitive Impairment: The Take a STAND for Health Study

Primary Purpose

Mild Cognitive Impairment

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Take a STAND for health
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Middle-aged and older adults with mild cognitive impairment confirmed by a team of neurologists from the CEREDIC HC-FMUSP

Exclusion Criteria:

  • Patients who spend less than 8 hours per day in sedentary time
  • Patients who are physically active (more than 150 min/week of moderate physical activity, or more than 75 min/week of vigorous activity)
  • Patients who are functional illiterates
  • Patients with history or clinical diagnosis of neurological diseases
  • Patients with severe psychiatric symptoms
  • Patients taking antidepressants
  • Patients with visual and/or hearing impairments that prevent participation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Take a STAND for health

    Control

    Arm Description

    A newly developed personalized intervention focused on replacing sedentary time with light-(or very light-) intensity physical activity

    The control group will receive regular medical care and advice on healthy lifestyle, including physical activity and healthy eating recommendations

    Outcomes

    Primary Outcome Measures

    Sedentary behaviour assessed by ActivPAL™

    Secondary Outcome Measures

    Physical activity levels assessed by ActiGraph GT3X®
    Cognitive performance assessed by the Montreal Cognitive Assessment (MoCA)
    Questionnaire to be completed by the patient. Final score 0 to 30, lower scores indicate worse cognitive performance
    Cognitive decline assessed by the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)
    Questionnaire to be completed by the caregiver. 26 Likert scale questions. Higher scores indicate worse cognitive performance
    Subjective memory complaints assessed by the Memory Complaint Scale (MCS)
    Questionnaire to be completed by the patient and the caregiver. Final scores classify memory complaints as absent, mild, moderate or accentuated
    Functional impairments in activities of daily living assessed by the Functional Activities Questionnaire (FAQ)
    Questionnaire to be completed by the caregiver. Final score 0 to 30, higher scores indicate greater functional dependency
    Anxiety symptoms assessed by the Geriatric Anxiety Inventory (GAI)
    Questionnaire to be completed by the patient. Final score 0 to 20, higher scores indicate greater anxiety symptoms
    Depression symptoms assessed by the Geriatric Depression Scale (GDS-15)
    Questionnaire to be completed by the patient. Final score 0 to 15, higher scores indicate greater depression symptoms
    Neurocognitive assessment assessed by the Cogstate Research™ (Cogstate, Melbourne, AUS)
    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
    Magnetic resonance imaging using the Philips ACHIEVA 3.0 Tesla
    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
    Positron emission computed tomography with 18F-fluordesoxyglucose (PET-18FDG) using the Biograph, CTI/Siemens, Knowville, EUA
    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
    Assessment of cerebrovascular reactivity to CO2 inhalation
    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
    Muscle functional assessed by the Timed Stands Test and the Timed Up-and-Go Test
    Test results will be combined to report muscle function
    Handgrip strength assessed by a hand dynamometer
    Patient will have three 5-second trials, with 1-minute interval between trials. Best score will be considered handgrip strength
    Blood pressure
    Fatigue severity assessed by the Fatigue Severity Scale (FSS)
    Physical and mental aspects of fatigue assessed by the Chalder Fatigue Scale (CFS)
    Subjective sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI)
    Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS)
    Quality of life assessed by the SF-36 (Medical Outcomes Study 36 - Short-Form Health Survey)
    Food consumption
    24-hour dietary recalls
    Insulin sensitivity
    Fasting serum concentrations of glucose, insulin
    Lipid profile
    Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides
    Inflammatory cytokines
    pro- and anti-inflammatory cytokines: IL-1, IL-1ra, IL-6, IL-10 e TNF-alpha
    Genetic profile for Alzheimer's disease
    Genotyping of apolipoprotein E (ApoE)
    Oral glucose tolerance test
    Fasting, 30, 60, 90, and 120 minutes

    Full Information

    First Posted
    July 30, 2020
    Last Updated
    August 13, 2020
    Sponsor
    University of Sao Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04507386
    Brief Title
    Reducing Sedentary Time in Patients With Mild Cognitive Impairment: The Take a STAND for Health Study
    Official Title
    Reducing Sedentary Time in Patients With Mild Cognitive Impairment: The Take a STAND for Health Study TS4H-MCI
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2020 (Anticipated)
    Primary Completion Date
    August 2024 (Anticipated)
    Study Completion Date
    August 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Sao Paulo

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mild Cognitive Impairment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Take a STAND for health
    Arm Type
    Experimental
    Arm Description
    A newly developed personalized intervention focused on replacing sedentary time with light-(or very light-) intensity physical activity
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm 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(s)
    Take a STAND for health
    Intervention Description
    The Take a STAND for health is a newly developed 4-month goal-setting intervention aimed at reducing sedentary behavior
    Primary Outcome Measure Information:
    Title
    Sedentary behaviour assessed by ActivPAL™
    Time Frame
    4 months
    Secondary Outcome Measure Information:
    Title
    Physical activity levels assessed by ActiGraph GT3X®
    Time Frame
    4 months
    Title
    Cognitive performance assessed by the Montreal Cognitive Assessment (MoCA)
    Description
    Questionnaire to be completed by the patient. Final score 0 to 30, lower scores indicate worse cognitive performance
    Time Frame
    4 months
    Title
    Cognitive decline assessed by the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)
    Description
    Questionnaire to be completed by the caregiver. 26 Likert scale questions. Higher scores indicate worse cognitive performance
    Time Frame
    4 months
    Title
    Subjective memory complaints assessed by the Memory Complaint Scale (MCS)
    Description
    Questionnaire to be completed by the patient and the caregiver. Final scores classify memory complaints as absent, mild, moderate or accentuated
    Time Frame
    4 months
    Title
    Functional impairments in activities of daily living assessed by the Functional Activities Questionnaire (FAQ)
    Description
    Questionnaire to be completed by the caregiver. Final score 0 to 30, higher scores indicate greater functional dependency
    Time Frame
    4 months
    Title
    Anxiety symptoms assessed by the Geriatric Anxiety Inventory (GAI)
    Description
    Questionnaire to be completed by the patient. Final score 0 to 20, higher scores indicate greater anxiety symptoms
    Time Frame
    4 months
    Title
    Depression symptoms assessed by the Geriatric Depression Scale (GDS-15)
    Description
    Questionnaire to be completed by the patient. Final score 0 to 15, higher scores indicate greater depression symptoms
    Time Frame
    4 months
    Title
    Neurocognitive assessment assessed by the Cogstate Research™ (Cogstate, Melbourne, AUS)
    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
    Time Frame
    4 months
    Title
    Magnetic resonance imaging using the Philips ACHIEVA 3.0 Tesla
    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
    Time Frame
    4 months
    Title
    Positron emission computed tomography with 18F-fluordesoxyglucose (PET-18FDG) using the Biograph, CTI/Siemens, Knowville, EUA
    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
    Time Frame
    4 months
    Title
    Assessment of cerebrovascular reactivity to CO2 inhalation
    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
    Time Frame
    4 months
    Title
    Muscle functional assessed by the Timed Stands Test and the Timed Up-and-Go Test
    Description
    Test results will be combined to report muscle function
    Time Frame
    4 months
    Title
    Handgrip strength assessed by a hand dynamometer
    Description
    Patient will have three 5-second trials, with 1-minute interval between trials. Best score will be considered handgrip strength
    Time Frame
    4 months
    Title
    Blood pressure
    Time Frame
    4 months
    Title
    Fatigue severity assessed by the Fatigue Severity Scale (FSS)
    Time Frame
    4 months
    Title
    Physical and mental aspects of fatigue assessed by the Chalder Fatigue Scale (CFS)
    Time Frame
    4 months
    Title
    Subjective sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI)
    Time Frame
    4 months
    Title
    Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS)
    Time Frame
    4 months
    Title
    Quality of life assessed by the SF-36 (Medical Outcomes Study 36 - Short-Form Health Survey)
    Time Frame
    4 months
    Title
    Food consumption
    Description
    24-hour dietary recalls
    Time Frame
    4 months
    Title
    Insulin sensitivity
    Description
    Fasting serum concentrations of glucose, insulin
    Time Frame
    4 months
    Title
    Lipid profile
    Description
    Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides
    Time Frame
    4 months
    Title
    Inflammatory cytokines
    Description
    pro- and anti-inflammatory cytokines: IL-1, IL-1ra, IL-6, IL-10 e TNF-alpha
    Time Frame
    4 months
    Title
    Genetic profile for Alzheimer's disease
    Description
    Genotyping of apolipoprotein E (ApoE)
    Time Frame
    4 months
    Title
    Oral glucose tolerance test
    Description
    Fasting, 30, 60, 90, and 120 minutes
    Time Frame
    4 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Middle-aged and older adults with mild cognitive impairment confirmed by a team of neurologists from the CEREDIC HC-FMUSP Exclusion Criteria: Patients who spend less than 8 hours per day in sedentary time Patients who are physically active (more than 150 min/week of moderate physical activity, or more than 75 min/week of vigorous activity) Patients who are functional illiterates Patients with history or clinical diagnosis of neurological diseases Patients with severe psychiatric symptoms Patients taking antidepressants Patients with visual and/or hearing impairments that prevent participation

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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