Pre-FRONTal Brain STability, Key for Action Against Disability in AGing: The FRONT STAGE Project
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 93
- 试验地点
- 10
- 主要终点
- Changes in hemoglobin oxygenation during functional tasks, as measured using fNIRS+fDCS optical techniques.
研究概览
简要总结
Cognitive and mobility impairments are critical contributors to dementia and disability in older adults, and can be caused by neurodegenerative and neurovascular changes at the pre-frontal (PF) brain areas. In a previous technological project funded by ISCiii, the investigators adapted a non-invasive, point-of-care optical methods (fNRIS/fDCS technology) to study PF metabolism and blood flow activation during cognitive and motor tasks, in older adults with and without cognitive impairment. These methods are sensitive to change after physical exercise (PE) and after selectively and safely stimulating PF areas with electrical transcranial direct current stimulation (tCS). PE and tCS have shown benefits for cognition and mobility in the elderly, but their prolonged effect on PF hemodynamic activation has not been studied. Understanding the specific action of these interventions on the brain, and their clinical cognitive and motor impact, is key to fine-tune appropriate treatment strategies.
The FRONT STAGE project aims to compare, through a 3 arms single-blind randomized clinical trial, the impact of a 10 weeks, 1 hour/week program of PE (arm 1) Vs PE+tCS (arm 2) and Vs a control group (arm 3, healthy aging sessions and control of cardiovascular risk factors). The PE program is already implemented in primary care, as part of another previous project of the investigators' research group. Outcomes will include the optical measurement of PF metabolism and blood flow and clinical measures of cognitive and physical function. Front STAGE project will recruit 93 older adults with cognitive impairment and slow gait, but without dementia or disability in the activities of daily living (N=31 per arm). They will receive a comprehensive geriatric assessment at baseline, together with the optical, cognitive and physical measures, and will be follow-up at 3 and 6 months. Weekly physical activity through accelerometry will be controlled in analyses.
FRONT STAGE project centered on aging and the prevention of dementia and disability, will provide, translationally, more evidence to support and enlarge the clinical application of these interventions, and will contribute to foster further research in this field.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The investigators performing the follow-up assessments will be blind to randomization. In light of the difficulty to guarantee a complete blinding, these investigators will record if blinding is disclosed by participants during the interview.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •older adults (65 years or older)
- •with Motoric Cognitive Risk Syndrome
- •characterized by impaired cognition (which in our case will be confirmed with a Spanish version of the Montreal cognitive Assessment (MOCA), score between 26 and 21)
- •mobility impairment (measured as slow gait speed<0.8 m/s)
- •without diagnosed clinical neurological or psychiatric diseases
- •with a preserved functional status for the activities of daily living
- •who can walk without help from third parties
排除标准
- •a diagnosis of dementia
- •advanced/terminal disease (life expectancy<1 year)
- •contraindications to exercise and tCS
- •unwilling to give informed consent
结局指标
主要结局
Changes in hemoglobin oxygenation during functional tasks, as measured using fNIRS+fDCS optical techniques.
时间窗: Baseline (prior to intervention), 3 and 6 months after completion of the intervention.
Our primary outcome will be prefrontal hemoglobin oxygenation during a) cognitive tests, such as phonetic verbal fluency and calculations (2-forward and 3-backward counting), b) normal gait, c) dual task (walking while counting). All the measures will be controlled for extra-cerebral and systemic contributions due to variations in heart-rate, oxygen saturation, respiration rate and end-tidal carbondioxide. Various measures such as those derived from accelerometers to account for potential motion artifacts will be also utilized, followed by a multi-subject analysis.
次要结局
- Cognitive executive function tests - Phonetic Verbal Fluency(Baseline (prior to intervention), 3 and 6 months after completion of the intervention.)
- Physical function(Baseline (prior to intervention), 3 and 6 months after completion of the intervention.)
- Motor function(Baseline (prior to intervention), 3 and 6 months after completion of the intervention.)
- Cognitive executive function tests - Digit span(Baseline (prior to intervention), 3 and 6 months after completion of the intervention.)
- Rey Auditory Verbal Learning Test (RAVLT)(Baseline (prior to intervention), 3 and 6 months after completion of the intervention.)
- Cognitive executive function tests - SDMT(Baseline (prior to intervention), 3 and 6 months after completion of the intervention.)
- Cognitive executive function tests - Trail Making Test(Baseline (prior to intervention), 3 and 6 months after completion of the intervention.)