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临床试验/NCT06313931
NCT06313931已完成不适用

Effects of Cognitive-motor Training on Cognition, Depression and Daily Functioning in Patients With Mild Cognitive Impairment (MCI): A Randomized Controlled Trial

Universidad de Zaragoza2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2023年7月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
2
主要终点
Short Geriatric Depression Scale (SGDS-S)

研究概览

简要总结

This randomized controlled trial evaluated the effectiveness of an immersive virtual reality (IVR) application (focused on a daily activity) to train cognitive functions and its impact on depression and the ability to perform activities of daily living (ADL) in patients with mild cognitive impairment (MCI). With a dose of two sessions per week during six weeks, the study showed significant improvements in cognitive functions and reduction in depression, with notable effects in the experimental group. This underscores the potential of IVR as a valuable tool in the management of MCI.

详细描述

Background:

The increase in cases of MCI underlines the urgency of finding effective methods to slow its progression. Given the limited effectiveness of current pharmacological options to prevent or treat the early stages of this deterioration, non-pharmacological alternatives are especially relevant.

Aim: The study aimed to evaluate the effectiveness of an immersive virtual reality (IVR) application, focused on an activity of daily living (ADL), to train cognitive functions and its impact on depression and the ability to perform ADL in patients with MCI. IVR is presented as an innovative tool with the potential to offer a promising non-pharmacological approach.

Methods:The researchers implemented a 40-minute-long intervention, twice a week for six weeks (totaling 12 sessions), using the cupboard task (based on IVR). The study included the participation of individuals with MCI, randomly distributed into control (n=12) and experimental (n=14) groups. The majority in the control group were women (75%), with a mean age of 77.67 years, and in the experimental group, women represented 57.14%, with a mean age of 74.86 years. Cognitive functions, depression, and the ability to perform ADLs were assessed. The scales used were: the Spanish version of the Montreal Cognitive Assessment (MoCA-S), the Short Geriatric Depression Scale (SGDS-S) and the Instrumental Activities of Daily Living Scale. (IADL-S), respectively.

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
Double (Participant, 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

入选标准

  • Age 65 or older
  • Community-dwelling, not in nursing homes
  • Physically functional
  • Understanding and voluntary consent
  • Mild Cognitive Impairment (MCI)
  • MoCA score of 19-25

排除标准

  • Clinical dementia diagnosis
  • MoCA ≤ 18 indicating probable dementia
  • Neurological disorders including stroke or TBI in the last year
  • History of mental/psychiatric disorders
  • Substance abuse
  • Difficulty using VR headset and controllers
  • Medical conditions affecting trial participation
  • Visual/hearing impairments
  • Communication difficulties

结局指标

主要结局

Short Geriatric Depression Scale (SGDS-S)

时间窗: 6 weeks

Scores in the SGDS scale. Higher scores mean a worse outcome.

Instrumental Activities of Daily Living Scale (IADL-S)

时间窗: 6 weeks

Scores in the IADL scale. Higher scores mean a better outcome.

Spanish version of the Montreal Cognitive Assessment (MoCA-S)

时间窗: 6 weeks

Scores in the MoCA-S scale. Higher scores mean a better outcome.

次要结局

未报告次要终点

研究者

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

Guillermo Palacios

Principal Investigator

Universidad de Zaragoza

研究点 (2)

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