Musical and Psychomotor Interventions for Cognitive, Sensorimotor, and Cerebral Decline in Patients With Mild Cognitive Impairment (COPE): a Study Protocol for a Multicentric Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 4
- 主要终点
- Cognitive Telephone Screening Instrument (COGTEL)
研究概览
简要总结
Cognitive decline represents a major threat among the deleterious effects of population aging. The investigators propose to conduct an RCT (randomized controlled trial) on the subpopulation of MCI patients, and examine whether intensive musical or psychomotor group interventions can improve their cognitive and sensorimotor functioning, as well as induce brain plasticity, compared to a passive healthy control group, matched for age, gender and education level. The 2 training regimens will take place twice a week over 6 months and will be provided by professionals in each field.
详细描述
Background Regular cognitive training can boost or maintain cognitive and brain functions known to decline with age. Most studies administered such cognitive training on a computer and in a lab setting. However, everyday life activities, like musical practice or physical exercise that are complex and variable, could be more successful at inducing transfer effects to different cognitive domains and maintaining motivation. "Body-mind exercises", like Tai Chi or psychomotor exercise, may also positively affect cognitive functioning in the elderly. We will investigate the influence of active music practice and psychomotor training over 6 months in Mild Cognitive Impairment patients from university hospital memory clinics on cognitive and sensorimotor performance and brain plasticity.
Methods We aim to conduct a randomized controlled (RCT) multicenter intervention study on 32 Mild Cognitive Impairment (MCI) patients (60-80 years), divided over 2 experimental groups: 1) Music practice; 2) Psychomotor treatment. Controls will consist of a passive test-retest group of 16 age, gender and education level matched healthy volunteers.
The training regimens take place twice a week for 45 minutes over 6 months in small groups, provided by professionals, and patients should exercise daily at home. Data collection takes place at baseline (before the interventions), 3, and 6 months after training onset, on cognitive and sensorimotor capacities, subjective well-being, daily living activities, and via functional and structural neuroimaging. Considering the current constraints of the ongoing COVID-19 (COronaVIrus Disease of 2019) pandemic, recruitment and data collection takes place in 2 waves.
Discussion We will investigate whether musical practice or psychomotor exercise in small groups can improve cognitive, sensorimotor and brain functioning in MCI patients, and therefore provoke benefits for their daily life functioning and well-being.
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
盲法说明
Patients will receive the information that 2 interventions to improve cognitive function in Mild Cognitive Impairment will be compared and that assignment to the interventions is random for scientific reasons.
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MCI diagnosis by experts at the memory clinics
- •MMSE score (Mini-Mental State Examination) > 22 or MoCA (Montreal Cognitive Assessment) > 18
- •Hospital Anxiety and Depression Scale (HADS) < 14 (< 7/21 for anxiety and < 7/21 for depression)
- •Age between 60 and 80 years
- •Right-handedness
- •Fluent in French
- •Able to give informed consent as documented by signature
排除标准
- •Serious motor deficits
- •Impaired/not-corrected hearing
- •Serious physical and mental comorbidities
- •Participation in physical or cognitive training over the last 12 months
- •Maximum 5 years of official music education over the lifespan outside the school curriculum or during the last 3 years
- •Intensive physical activity over the last 12 months (sports or body-mind exercises)
- •Left-handed or ambidextrous
- •MRI incompatibility (claustrophobia, cardiac stimulator, implants...)
- •Nota bene: for brain organizational reasons exclusively right-handed participants will be included. Right-handed persons represent more than 90% of the population (Isaacs, Barr, Nelson, & Devinsky, 2006., doi:10.1212/01.wnl.0000219623.28769.74.)
结局指标
主要结局
Cognitive Telephone Screening Instrument (COGTEL)
时间窗: 6 months
This test can be applied by telephone or face-to-face (in this study we will apply the face-to-face method). The outcome consists of increase or less decrease (experimental group 1 or 2 vs. the control group) of the total weighted score at the COGTEL test directly after the 6 months interventions as compared to directly before the interventions. The COGTEL test provides a main weighted score of core cognitive function, it comprises 6 subtests covering prospective memory, short- and long-term verbal memory, working memory (digit span), verbal fluency and inductive reasoning. COGTEL main weighted score: COGTEL Total score = 7.2 x Prospective Memory score + 1.0 x Verbal Short-Term Memory score + 0.9 x Verbal Long-Term Memory score + 0.8 x Working Memory score + 0.2 x Verbal Fluency score + 1.7 x Inductive Reasoning score (Kliegel, Martin, \& Jager, 2007, doi:10.3200/JRLP.141.2.147-172) (lhle et al., 2017, doi:10.1159/000479680)
次要结局
- D2-R test(6 months)
- Emotional regulation questionnaire (ERQ)(6 months)
- Trail making test(6 months)
- Go/No-Go(6 months)
- Resting state functional MRI (RS-fMRI)(6 months)
- Diffusion Tensor Imaging (DTI)(6 months)
- Individual subtests of the COGTEL (Cognitive Telephone Screening Instrument)(6 months)
- fMRI visual working memory task(6 months)
- Magnetization Prepared 2 Rapid Gradient Echo (MP2RAGE)(6 months)
- International Matrix Test (Oldenburg)(6 months)
- Sensorimotor function(6 months)
- Short Version of the Amsterdam Instrumental Activity of the Daily Living Questionnaire (A-IADL-Q(SV))(6 months)
- World Health Organization Quality of Life Instruments - short Version WHOQOL-BREF (abbreviated World Health Organization Quality of Life; WHO 1996)(6 months)
- Functional MRI (fMRI)(6 months)