Reducing Sedentary Time in Patients With Mild Cognitive Impairment: The Take a STAND for Health Study TS4H-MCI
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- Sedentary behaviour assessed by ActivPAL™
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Middle-aged and older adults with mild cognitive impairment confirmed by a team of neurologists from the CEREDIC HC-FMUSP
排除标准
- •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
结局指标
主要结局
Sedentary behaviour assessed by ActivPAL™
时间窗: 4 months
次要结局
- Physical activity levels assessed by ActiGraph GT3X®(4 months)
- Cognitive performance assessed by the Montreal Cognitive Assessment (MoCA)(4 months)
- Cognitive decline assessed by the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)(4 months)
- Subjective memory complaints assessed by the Memory Complaint Scale (MCS)(4 months)
- Functional impairments in activities of daily living assessed by the Functional Activities Questionnaire (FAQ)(4 months)
- Anxiety symptoms assessed by the Geriatric Anxiety Inventory (GAI)(4 months)
- Depression symptoms assessed by the Geriatric Depression Scale (GDS-15)(4 months)
- Neurocognitive assessment assessed by the Cogstate Research™ (Cogstate, Melbourne, AUS)(4 months)
- Magnetic resonance imaging using the Philips ACHIEVA 3.0 Tesla(4 months)
- Positron emission computed tomography with 18F-fluordesoxyglucose (PET-18FDG) using the Biograph, CTI/Siemens, Knowville, EUA(4 months)
- Assessment of cerebrovascular reactivity to CO2 inhalation(4 months)
- Muscle functional assessed by the Timed Stands Test and the Timed Up-and-Go Test(4 months)
- Handgrip strength assessed by a hand dynamometer(4 months)
- 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)
- Insulin sensitivity(4 months)
- Lipid profile(4 months)
- Inflammatory cytokines(4 months)
- Genetic profile for Alzheimer's disease(4 months)
- Oral glucose tolerance test(4 months)
研究者
Bruno Gualano
Professor
University of Sao Paulo