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
About this trial
This is an interventional treatment trial for Mild Cognitive Impairment
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
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
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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Reducing Sedentary Time in Patients With Mild Cognitive Impairment: The Take a STAND for Health Study
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