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

Reducing Sedentary Time in Patients With Mild Cognitive Impairment: The Take a STAND for Health Study TS4H-MCI

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 Overview

• Status: Not yet recruiting
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: Take a STAND for health

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Take a STAND for health; A newly developed personalized intervention focused on replacing sedentary time with light-(or very light-) intensity physical activity	Behavioral: Take a STAND for health; The Take a STAND for health is a newly developed 4-month goal-setting intervention aimed at reducing sedentary behavior
No Intervention: Control; The control group will receive regular medical care and advice on healthy lifestyle, including physical activity and healthy eating recommendations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sedentary behaviour assessed by ActivPAL™	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure		4 months
Physical activity levels assessed by ActiGraph GT3X®		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	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	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	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	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	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	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	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	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	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	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	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	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	24-hour dietary recalls	4 months
Insulin sensitivity	Fasting serum concentrations of glucose, insulin	4 months
Lipid profile	Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides	4 months
Inflammatory cytokines	pro- and anti-inflammatory cytokines: IL-1, IL-1ra, IL-6, IL-10 e TNF-alpha	4 months
Genetic profile for Alzheimer's disease	Genotyping of apolipoprotein E (ApoE)	4 months
Oral glucose tolerance test	Fasting, 30, 60, 90, and 120 minutes	4 months

Collaborators and Investigators

• Sponsor: University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2020
• Primary Completion (Anticipated): August 1, 2024
• Study Completion (Anticipated): August 1, 2024

Study Registration Dates

• First Submitted: July 30, 2020
• First Submitted That Met QC Criteria: August 7, 2020
• First Posted (Actual): August 11, 2020

Study Record Updates

• Last Update Posted (Actual): August 17, 2020
• Last Update Submitted That Met QC Criteria: August 13, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: Take a STAND for Health MCI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No