Clinical trial NCT04507386: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2020-08-11
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Sedentary behaviour assessed by ActivPAL™
timeFrame: 4 months
Secondary outcomes:
measure: Physical activity levels assessed by ActiGraph GT3X®
timeFrame: 4 months
measure: Cognitive performance assessed by the Montreal Cognitive Assessment (MoCA)
timeFrame: 4 months
measure: Cognitive decline assessed by the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)
timeFrame: 4 months
measure: Subjective memory complaints assessed by the Memory Complaint Scale (MCS)
timeFrame: 4 months
measure: Functional impairments in activities of daily living assessed by the Functional Activities Questionnaire (FAQ)
timeFrame: 4 months
measure: Anxiety symptoms assessed by the Geriatric Anxiety Inventory (GAI)
timeFrame: 4 months
measure: Depression symptoms assessed by the Geriatric Depression Scale (GDS-15)
timeFrame: 4 months
measure: Neurocognitive assessment assessed by the Cogstate Research™ (Cogstate, Melbourne, AUS)
timeFrame: 4 months
measure: Magnetic resonance imaging using the Philips ACHIEVA 3.0 Tesla
timeFrame: 4 months
measure: Positron emission computed tomography with 18F-fluordesoxyglucose (PET-18FDG) using the Biograph, CTI/Siemens, Knowville, EUA
timeFrame: 4 months
measure: Assessment of cerebrovascular reactivity to CO2 inhalation
timeFrame: 4 months
measure: Muscle functional assessed by the Timed Stands Test and the Timed Up-and-Go Test
timeFrame: 4 months
measure: Handgrip strength assessed by a hand dynamometer
timeFrame: 4 months
measure: Blood pressure
timeFrame: 4 months
measure: Fatigue severity assessed by the Fatigue Severity Scale (FSS)
timeFrame: 4 months
measure: Physical and mental aspects of fatigue assessed by the Chalder Fatigue Scale (CFS)
timeFrame: 4 months
measure: Subjective sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 4 months
measure: Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS)
timeFrame: 4 months
measure: Quality of life assessed by the SF-36 (Medical Outcomes Study 36 - Short-Form Health Survey)
timeFrame: 4 months
measure: Food consumption
timeFrame: 4 months
measure: Insulin sensitivity
timeFrame: 4 months
measure: Lipid profile
timeFrame: 4 months
measure: Inflammatory cytokines
timeFrame: 4 months
measure: Genetic profile for Alzheimer's disease
timeFrame: 4 months
measure: Oral glucose tolerance test
timeFrame: 4 months
Other outcomes:
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