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

University of Sao Paulo60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mild Cognitive Impairment

Interventions

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Sedentary behaviour assessed by ActivPAL™

Time frame: 4 months

Secondary Outcomes

Physical activity levels assessed by ActiGraph GT3X®

Time frame: 4 months

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

Time frame: 4 months

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

Time frame: 4 months

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

Time frame: 4 months

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

Time frame: 4 months

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

Time frame: 4 months

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

Time frame: 4 months

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

Time frame: 4 months

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

Time frame: 4 months

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

Time frame: 4 months

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

Time frame: 4 months

Muscle functional assessed by the Timed Stands Test and the Timed Up-and-Go Test

Test results will be combined to report muscle function

Time frame: 4 months

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

Time frame: 4 months

Blood pressure

Time frame: 4 months

Fatigue severity assessed by the Fatigue Severity Scale (FSS)

Time frame: 4 months

Physical and mental aspects of fatigue assessed by the Chalder Fatigue Scale (CFS)

Time frame: 4 months

Subjective sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI)

Time frame: 4 months

Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS)

Time frame: 4 months

Quality of life assessed by the SF-36 (Medical Outcomes Study 36 - Short-Form Health Survey)

Time frame: 4 months

Food consumption

24-hour dietary recalls

Time frame: 4 months

Insulin sensitivity

Fasting serum concentrations of glucose, insulin

Time frame: 4 months

Lipid profile

Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides

Time frame: 4 months

Inflammatory cytokines

pro- and anti-inflammatory cytokines: IL-1, IL-1ra, IL-6, IL-10 e TNF-alpha

Time frame: 4 months

Genetic profile for Alzheimer's disease

Genotyping of apolipoprotein E (ApoE)

Time frame: 4 months

Oral glucose tolerance test

Fasting, 30, 60, 90, and 120 minutes

Time frame: 4 months