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临床试验/NCT02730065
NCT02730065Unknown不适用

Effects of Aerobic Dance Training on Cognitive Functions, Mood and Physical Functions in Community Elderly Persons With Cerebral Small Vessel Disease

Chinese University of Hong Kong2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2016年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
110
试验地点
2
主要终点
Cognition assessed by the 30-minute protocol of the National Institute of Neurological Diseases and Stroke - Canadian Stroke Network VCI protocol summary score

研究概览

简要总结

Introduction: Cerebral small vessel disease (SVD) is associated with age-related disabilities including dementia, depression, physical and functional impairment. Chinese are more prone to developing SVD than Caucasians. Physical exercise may improve multiple negative consequences associated with SVD.

Objective and hypothesis to be tested: To examine the effects of a 24-week structured aerobic dance training on cognition, mood, physical and daily functions in stroke and dementia free older adults with SVD, and whether such effects are mediated through improved cerebral vasomotor reactivity (CVR), a marker of cerebral autoregulation which is impaired in SVD.

Design and subjects: Rater-blind RCT comparing the effects of 24-week of structured aerobic dance training upon cognition, mood, physical and daily functions on 110 community dwelling, stroke- and dementia-free persons aged ≥65 with MRI evidence of significant SVD, defined as the presence of multiple (≥2) lacunes and/or early confluent or confluent WML.

Interventions: Participants are randomized in a 1:1 ratio into a 24-week of structured therapist-led group aerobic dance training with home practice or simple stretching plus health education control group.

Main outcome measures: Cognition, mood, physical and daily functions and CVR measured using Transcranial Doppler at baseline, weeks 12, 24 and 36.

Data analysis: Intent-to-treat with multiple imputations with treatment efficacy analyzed using mixed effects models. Mediation effects of CVR between aerobic dance training and treatment outcomes tested using mediation models.

Expected results: In persons with significant SVD, aerobic dance training improves cognitive, mood, physical and daily functions and such effects are mediated by changes in CVR.

详细描述

Cerebral small vessel disease (SVD) is manifested as age-related white matter lesions (WML) and lacunar infarcts and on brain imaging. SVD is prevalent in the elderly population. In community dwelling persons ≥ 60 years of age, up to a quarter had lacunar infarcts and 96% had varying degree of WML. Significant SVD, namely early confluent or confluent WML and multiple lacunar infarcts, are found in up to 1 in every 5 elderly persons. In a previous study we found that Chinese are more prone to develop significant SVD than Caucasians. SVD is associated with a plethora of age-related disabilities such as dementia, falls, depression, impaired daily functioning and death Cognition - SVD is the most common cause of vascular cognitive impairment (VCI) and vascular dementia, which is the second most prevalent type of dementia. Community elderly persons with SVD had two-fold increased risk of developing dementia when compared to those without. SVD may direct damage neural structures, disrupt connectivity or cause atrophy in brain regions important for cognitive functioning. Depression - Disconnection of frontosubcortical pathways by SVD contributes to late-life depression, and increased comorbidity of depression and SVD has been observed in the older populations. Depression contributes to poor quality of life and death in older persons.

Physical impairment - increased severity of SVD is associated with poor physical functions including poor gait and balance. SVD is a strong risk factor for falls, a major contributing factor for disability and death in older persons. In summary, non-disabled older adults with SVD are at high risk of multiple disabilities.

As the elderly population in Hong Kong is projected to triple over the next 30 years, means to prevent age-related disabilities such as cognitive decline, depression and physical impairments in vulnerable individuals are of enormous importance to the patient, family and healthcare system. Existing preventive therapies mainly involve medications to control vascular risk factors associated with SVD. Primary prevention by means of lifestyle intervention is therefore of utmost importance.

Evidence on effects of physical activities upon cognition, mood and physical functions The health values of physical activities are well recognized. Physical activities can be performed by anybody at any time and place at minimal cost. Physical activities are shown to improve the clinical conditions associated with SVD. For cognition, physical activities are associated with reduced risk of cognitive decline in normal and cognitively impaired elderly persons. Aerobic and strength training improved executive functions, memory and general cognitive functions in community-dwelling adults with mild cognitive impairment. The investigators showed that in a large cohort (n=1,013) of stroke patients free of dementia before the stroke, participation in regular physical activities reduced 79% of risk of incident dementia after stroke. With regard to the mechanism, physical activities may improve endothelial functions and blood perfusion and neuroplasticity in brain regions mediating cognitive functions. Moreover, physical exercise may protect cognition by reducing incident strokes, which is particular relevant to people with SVD due to their increased risk of strokes. A randomized controlled trial (RCT) showed that a 24-week, 3 x 50-minute per week of moderate intensity exercise intervention significantly improved cognitive functions in patients at risk of AD, with outcome effect size superior to that reported for drug treatment in another study. Moreover, treatment benefits persisted at least one year after active intervention, suggesting that physical exercise is associated with enduring changes in the neurological substrate underpinning cognitive functioning. However, this study only recruited patients likely to have degenerative (Alzheimer's) pathology. For mood, physical activities may protect against depression in older adults. For physical functions, the investigators previously showed that physical exercise training improved balance, gait performance, exercise endurance and quality of life in local patients with Parkinson's Disease (PD). Taken together, there is good evidence that physical activities can improve many of the negative consequences of cerebral SVD.

Possible biological mechanism underlying physical exercise in SVD The development of SVD is hypothesized to be related to endothelial dysfunction that results from chronic hypertension impairs cerebral vasomotor reactivity (CVR), a marker of cerebral autoregulation. Changes in CVR may reflect impairment in the homeostasis of blood pressure in the brain, hence cerebral perfusion becomes more dependent on the systemic blood pressure. Ischemia occurs in response to drop of systemic blood pressure and lead to hypoperfusion and subsequently the development of SVD. Using Transcranial Doppler (TCD) ultrasonography, our group previously showed that decreased CVR is associated with SVD. Reduced CVR is linked to cognitive decline, depression and poor physical functions in elderly persons. Physical exercise may lead to significant improvement in CVR. These data suggest that physical exercise is likely to benefit cognition, mood and physical functions in persons with SVD due to its positive effects on CVR.

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 (Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Community dwelling
  • •Presence of significant SVD, defined by the presence of multiple (≥2) lacunar infarcts and/or a rating of ≥2 (i.e. beginning confluence of lesions to diffuse involvement of lesions in periventricular and/or deep white matter) of WML using the Age-related White Matter Changes (ARWMC) Scale on MRI
  • •Presence of good temporal window on at least one side for TCD evaluation
  • •Written informed consent given

排除标准

  • •History of stroke
  • •Dementia, determined by a score on Cantonese MMSE less than education adjusted cutoff score for dementia or history of dementia diagnosis
  • •Comorbidity with medical conditions affecting the central nervous system or cerebral white matter
  • •Inadequately controlled psychiatric disorders affecting cognition and mood
  • •Physical or sensory impediments hindering participation in cognitive assessment or exercise training.

研究组 & 干预措施

Structured Aerobic Dance Training Group

Active Comparator

Active intervention will last for 24 weeks and consists of 60-minute/session, which includes 10 minutes warm-up, 40 minutes of dancing and 10 minutes of cool down. In groups of 5, participants will practice the dance led by a physiotherapist once per week for the first 2 months and twice per week for 3rd to 6th month.

干预措施: Structured Aerobic Dance Training Group (Behavioral)

Stretching plus education

Placebo Comparator

Participants in the control group will receive a weekly 3-hour group-based (group of 5 participants) programme containing stretching exercise, stress reduction and health education on dementia and stroke prevention for 6 months. The programme consists of low-intensity seated stretching, psychoeducation on stress management, various relaxation methods with practice as well as education on the causes, identification, treatment and prevention of stroke and dementia. Benefits of physical exercise will also be discussed but will its weight will be evenly balanced with other forms of evidence-based preventive strategies.

干预措施: Stretching plus education (Behavioral)

结局指标

主要结局

Cognition assessed by the 30-minute protocol of the National Institute of Neurological Diseases and Stroke - Canadian Stroke Network VCI protocol summary score

时间窗: Change from baseline to week 24

Depressive symptoms evaluated the Geriatric Depression Scale

时间窗: Change from baseline to week 24

Walking capacity assessed by the 6-minute walk test

时间窗: Change from baseline to week 24

Physical balance measured by the Mini-Balance Evaluation Systems Test

时间窗: Change from baseline to week 24

Functional mobility measured by the Timed-up-and-go test

时间窗: Change from baseline to week 24

Daily functioning evaluated by the Lawton's Instrumental Activities of Daily Living

时间窗: Change from baseline to week 24

次要结局

  • Cerebral vasomotor reactivity measured by Pulsatility Index obtained from middle cerebral artery and vertebral artery measured on Transcranial Doppler(Change from baseline to week 24)
  • Cerebral vasomotor reactivity measured by Breath Holding Index obtained from middle cerebral artery and vertebral artery measured on Transcranial Doppler(Change from baseline to week 24)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adrian Wong

Research Assistant Professor

Chinese University of Hong Kong

研究点 (2)

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