Reducing Sedentary Time in Patients With Mild Cognitive Impairment: The Take a STAND for Health Study
- Conditions
- Mild Cognitive Impairment
- Interventions
- Behavioral: Take a STAND for health
- Registration Number
- NCT04507386
- Lead Sponsor
- University of Sao Paulo
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- Middle-aged and older adults with mild cognitive impairment confirmed by a team of neurologists from the CEREDIC HC-FMUSP
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Take a STAND for health Take a STAND for health A newly developed personalized intervention focused on replacing sedentary time with light-(or very light-) intensity physical activity
- Primary Outcome Measures
Name Time Method Sedentary behaviour assessed by ActivPAL™ 4 months
- Secondary Outcome Measures
Name Time Method Physical activity levels assessed by ActiGraph GT3X® 4 months Cognitive performance assessed by the Montreal Cognitive Assessment (MoCA) 4 months 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) 4 months 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) 4 months 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) 4 months 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) 4 months 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) 4 months 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) 4 months 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 4 months 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 4 months 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 4 months 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 4 months Test results will be combined to report muscle function
Handgrip strength assessed by a hand dynamometer 4 months Patient will have three 5-second trials, with 1-minute interval between trials. Best score will be considered handgrip strength
Blood pressure 4 months Fatigue severity assessed by the Fatigue Severity Scale (FSS) 4 months Physical and mental aspects of fatigue assessed by the Chalder Fatigue Scale (CFS) 4 months Subjective sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI) 4 months Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS) 4 months Quality of life assessed by the SF-36 (Medical Outcomes Study 36 - Short-Form Health Survey) 4 months Food consumption 4 months 24-hour dietary recalls
Insulin sensitivity 4 months Fasting serum concentrations of glucose, insulin
Lipid profile 4 months Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides
Inflammatory cytokines 4 months pro- and anti-inflammatory cytokines: IL-1, IL-1ra, IL-6, IL-10 e TNF-alpha
Genetic profile for Alzheimer's disease 4 months Genotyping of apolipoprotein E (ApoE)
Oral glucose tolerance test 4 months Fasting, 30, 60, 90, and 120 minutes