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临床试验/NCT07542535
NCT07542535已完成不适用

Effects of an Active Musical Intervention on the Health of Older Adults Living With Dementia: the DeMúsica Study, a Cross-over Trial on a Non-pharmacological Intervention

Instituto Nacional de Geriatria, Mexico1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2025年11月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
7
试验地点
1
主要终点
Neuropsychiatric symptoms

研究概览

简要总结

Older adults constitute a population whose age-related physiological and cognitive changes predispose them to conditions that are less likely to occur in younger individuals. Dementia encompasses a group of health conditions that primarily affect this age group. These disorders commonly impair mental functions-particularly memory-but they also manifest through behavioral symptoms, such as irritability, and exert a significant impact not only on the affected individual but also on their immediate environment.

In this study, the investigators will implement a structured musical improvisation intervention led by four professional concert musicians. This approach, which has demonstrated effectiveness in other populations, aims to evaluate its effects on the mental and physical health of older adults living with dementia. Additionally, the intervention will be assessed in terms of its potential impact on primary caregivers, thereby exploring its reach beyond the individual diagnosed with dementia.

Previous studies have reported the effectiveness of such interventions, noting improvements in memory, behavioral symptoms, and even overall physical well-being. To date, no studies of this nature have been conducted in our country, making this the first to pursue an extensive exploration of outcomes-not only those traditionally assessed in similar trials, but also a broader evaluation of various dimensions of health in older adults undergoing the intervention. Additionally, caregivers may also benefit from actively participating in these sessions, which are designed to include them from the very beginning. Beyond generating data on the potential effects across different bodily and cognitive functions-knowledge that may become a leading reference in this field-this intervention holds the potential to be scaled up, thereby benefiting a larger population and ultimately enhancing the care provided to older adults living with dementia.

详细描述

Older adults are a group of people whose age makes them prone to developing conditions they would not have if they were younger. Dementias are a group of health conditions that commonly occur in older adults. They are a group of conditions that affect, among other mental functions, memory; but they often present other behavioral manifestations (such as irritability) and impact not only the person suffering from them, but also those around them. In this study, the investigators will use musical improvisation led by four concert musicians through a structured intervention which has proven effective in other populations-to understand the effects on the mental and physical health of older adults with dementia; the investigators will also assess caregivers to determine whether this intervention has an impact beyond the person with dementia. There is evidence regarding the effectiveness of these treatments, with improvements observed in memory, behavioral symptoms, and even the person's overall physical condition. On the other hand, it will be the caregivers who may also benefit by actively participating in these sessions, which involve them from the very beginning.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • Older adults aged 60 years or older
  • Positive screening result for Alzheimer´s disease, vascular dementia, or mixed dementia
  • Prior diagnosis of dementia in a mild or moderate stage
  • Individuals capable of performing minimal physical activity
  • Complete vaccination schedule for COVID-19 and influenza

排除标准

  • Individuals currently participating in a similar intervention or received similar intervention within the past 6 months
  • Undergoing continous treatment for another health condition

研究组 & 干预措施

Music therapy in caregiver burden of dementia patients: A quasi-experimental study

Experimental

The intervention will be assessed in terms of its potential impact on primary caregivers, thereby exploring its reach beyond the individual diagnosed with dementia. Additionally, two other outcomes will be assessed as secondary goals: frailty and neuropsychiatric symptoms.

干预措施: Music Therapy (Other)

结局指标

主要结局

Neuropsychiatric symptoms

时间窗: 8 weeks

This outcome was assessed with the Neuropsychiatric Inventory Questionnaire, has a score that ranges from 0 to 12, with the lowest score meaning no neuropsychiatric symptoms and 12 the highest neuropsychiatric symptom burden possible. Additionally, if the symptom is present, a severity scale is applied for the symptom, that ranges from 0 to 36.

次要结局

  • Caregiver burden(8 weeks)
  • Frailty(8 weeks)
  • Depression(8 weeks)

研究者

发起方
Instituto Nacional de Geriatria, Mexico
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Mario Ulises Perez Zepeda

Clinical Researcher

Instituto Nacional de Geriatria, Mexico

研究点 (1)

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