Randomized Interventional Prospective Study of the Effect of Physical Activity in Vascular Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Clinical Cognitive Criteria
研究概览
简要总结
Vascular cognitive impairment (VCI) is one of the most frequent causes of cognitive impairment associated with aging. So far, there is no approved treatment for VCI. Recent studies have suggested a protective effect from physical activity but adequate studies are lacking in this field. The AFIVASC study - a Portuguese acronym for "physical activity in vascular cognitive impairment" is a randomized controlled study, single-blinded, nonpharmacological which aims to explore the benefits of physical activity in vascular cognitive impairment (VCI)
详细描述
Vascular cognitive impairment is one of the most frequent causes of cognitive impairment associated with aging. Vascular cognitive impairment includes clinical deficits due to vascular subclinical brain injury, silent lesions or due to clinically overt stroke, and appears frequently associated with Alzheimer disease. Vascular cognitive impairment has a spectrum of manifestations, from mild to extreme manifestation (Vascular Dementia) that represents the second most frequent cause of dementia. There is no approved treatment for vascular cognitive impairment, and pharmacological trials have generated disappointing results. As a result, nowadays, treatment is solely based on the control of vascular risk factors.
Walking is a physical activity recommended for the prevention of coronary disease. Besides, it is a physical activity without additional costs, easily accessible to the general population, and can be used in the whole population. Physical activity can potentially prevent functional decline associated with aging and promote global health status. In recent years, a growing interest has been given to the impact of physical activity as a protective factor for cognitive decline and for the progression for dementia There are several explanations for the protective effect in cognition: physical activity can implicate a better physical and global mental status, but can also be mediated through metabolic, physiopathological effects, as the increase cerebral inflow, the reduction of vascular risk factors, the decrease of production of stress hormones or still better endothelial function, among others.
However, there is no consensus in this field.
Some studies showed a protective effect of physical activity in Alzheimer disease. Protective effect of physical activity on vascular cognitive impairment (including dementia) has still to be proved. There are small studies with short follow-up, that do not take in consideration relevant confounding factors or imaging data (e.g. evidence of small vessel disease) with controversial results.
Recently a large observational study showed the beneficial impact of physical activity (defined according to the American Heart Association as at least 30 minutes of physical activity at least 3 times a week) in the reduction of the risk of progression for vascular dementia, in a cohort of subjects older than 65 years old, living independently, with cerebral white matter changes, and controlling for confounding factors. Additionally, in subjects with evidence of small vessel disease and no cognitive decline, physical activity was associated with better executive performance overtime.
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
- Single (Investigator)
盲法说明
Single-blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants are included if they are older than 18 years
- •Fluent in Portuguese language;
- •Able to read and write;
- •Availability of a reliable informant;
- •Fulfill the written informed consent;
- •Clinical and functional criteria A and B:
- •Criteria A: 1 of the following 3:
- •Probable mild cognitive vascular impairment;
- •Previous ischemic or hemorrhagic stroke (at least 6 months before), with modified Rankin ≤ 2 at baseline and without formal indication for physiotherapy.
- •TIA (at least more than a 1 month before), diagnosed by a neurologist or with identified vascular lesion (correlated with TIA clinical symptoms) in CT/MRI.
- •Criteria B: No functional changes: IADL 0 (no item changed, or 1 single item with minimal change), according to the scoring methods of the LADIS study (minimum of 4 items applicable) or no cognitive changes regarding the suggested Montreal Cognitive Assessment Test (Moca) cut off point for dementia in clinical Portuguese samples (score < 17).
- •Exclusion Criteria(Subjects cannot be included if they have at least one of the following):
- •Diagnosis of dementia;
- •Stroke with formal indication for physiotherapy or speech therapy, or Rankin ≥ 2;
- •Any contraindication for walking, physical limitation to gait (orthopedic or other structural) that compromises the therapy proposed, or physical or mental limitation that could potentially interfere with the active treatment proposed (e.g. severe arthritis, severe osteoarticular pain associated with walking);
- •Evidence of neurodegenerative disease (other than vascular aetiology), significant psychiatric disease (e.g. major depressive episode) or medical disease with prognosis or severity which could significantly interfere with the subjects' participation, or with quality of life (e.g. cancer, severe cardiovascular disease as congestive heart failure, uncontrolled angina).
排除标准
- 未提供
结局指标
主要结局
Clinical Cognitive Criteria
时间窗: 1 year
Defined by a transition to dementia (all types) in patients with vascular cognitive impairment no dementia or transition to vascular cognitive impairment no dementia in those subjects with previous stroke/TIA without criteria for vascular cognitive impairment no dementia. This cognitive criteria will be assessed by a clinical neurologist
Cognitive Status measured by neuropsychological measures
时间窗: 1 year
Change in neuropsychological evaluation (1.5 SD of initial medium score) for composite scores calculated by averaging all different domains of the tests applied or for global measures (MOCA).
次要结局
- Impact of physical activity in interpersonal, environmental, functional, physical, and psychological domains (Quality of Life) measured by Portuguese version of Quality of Live scale in Alzheimer's disease (QOL-AD)(1 year)
- Impact of physical activity in motor status(1 year)
- Impact of physical activity in functional status(1 year)
研究者
Ana Verdelho
Principal Investigador, Clinical Professor, Neurologist
Instituto de Medicina Molecular João Lobo Antunes