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Immersive Nature-Based Wellbeing Program in Older Adults With Cognitive Impairment (COGNITIO)

2026年9月1日 更新者:Maite Garolera、Consorci Sanitari de Terrassa

Cognitio Avançada: Immersive Nature-Based Wellbeing Program for Older Adults With Cognitive Impairment: A Quasi-Experimental Pre-Post Study

This study aims to evaluate an immersive virtual reality program designed to support cognitive and emotional well-being in older adults with mild to moderate cognitive impairment. The program uses nature-based environments combined with mindfulness, cognitive stimulation, and breathing techniques. The goal is to determine whether immersive virtual reality can be a safe and effective tool to improve well-being and support active and healthy aging.

The study will be conducted in two phases. In the first phase, virtual environments will be tested in healthy participants using behavioral and physiological measures. In the second phase, 200 older adults with cognitive impairment from day care centers and residential facilities will participate in a group-based immersive virtual reality intervention consisting of 10 sessions.

Researchers will assess changes in cognitive function, emotional wellbeing, daily functioning, and quality of life before and after the intervention.

研究概览

详细说明

This study evaluates the effectiveness of an immersive virtual reality program based on nature environments to improve cognitive function, emotional well-being, functional ability, and quality of life in older adults with mild to moderate cognitive impairment.

Cognitive impairment is common in older adults and can negatively affect independence, emotional well-being, and quality of life. Non-pharmacological interventions using emerging technologies, such as immersive virtual reality, offer new opportunities to support cognitive and emotional health. Nature-based virtual environments may help reduce stress, improve mood, and increase engagement, even in individuals with limited mobility or access to natural settings.

The study takes place across services affiliated with Suara Cooperativa. In Phase 1, researchers test and validate immersive virtual environments in healthy participants. Participants attend individual sessions where they view nature-based virtual scenarios. Researchers collect behavioral, subjective, and physiological data, including electroencephalography, heart rate, electrodermal activity, and respiration, to assess safety, usability, and emotional responses to the virtual environments.

In Phase 2, researchers conduct a quasi-experimental pre-post study without a control group. The study includes 200 participants (100 with mild cognitive impairment and 100 with moderate cognitive impairment) recruited from day care centers and residential facilities managed by Suara Cooperativa.

Participants take part in a structured group-based intervention consisting of 10 immersive virtual reality sessions. The program combines exposure to nature-based virtual environments with mindfulness practices, cognitive stimulation activities, and breathing techniques to promote emotional regulation and cognitive engagement. The intervention is accessible, engaging, and adapted to the needs of older adults with cognitive impairment.

Primary outcome measures include cognitive function, emotional well-being, functional capacity in activities of daily living, and quality of life. Researchers also assess participant engagement and acceptability of the intervention as secondary measures.

Researchers analyze data using descriptive and inferential statistical methods to assess changes between pre- and post-intervention measures. They also evaluate adherence to the intervention and participant satisfaction.

This study aims to generate evidence on the potential of immersive virtual reality as an innovative, safe, and accessible non-pharmacological intervention to support cognitive health, emotional well-being, and autonomy in older adults, contributing to active and healthy aging.

研究类型

介入性

注册 (估计的)

230

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Maite Garolera, PhD
  • 电话号码:1558 +34937310007
  • 邮箱:mgarolera@cst.cat

学习地点

    • Barcelona
      • Terrassa、Barcelona、西班牙、08227
        • 招聘中
        • Consorci Sanitari de Terrassa
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 年长者

接受健康志愿者

是的

描述

Inclusion Criteria:

  • Age ≥ 65 years
  • Diagnosis of mild or moderate cognitive impairment
  • Ability to understand study procedures and follow instructions
  • Ability to provide informed consent (or consent provided by a legal representative)
  • Attendance at participating day care centers or residential facilities (Phase 2)
  • For Phase 1: healthy adults without cognitive impairment

Exclusion Criteria:

  • Severe cognitive impairment or diagnosis of advanced dementia
  • Severe visual, auditory, or motor impairments that prevent use of virtual reality
  • Neurological or psychiatric conditions that may interfere with participation
  • History of epilepsy or conditions contraindicating virtual reality exposure
  • Severe behavioral disturbances or agitation
  • Participation in other clinical studies that may interfere with results

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Immersive virtual reality intervention
Participants receive a group-based immersive virtual reality intervention consisting of 10 sessions using nature-based environments combined with mindfulness, cognitive stimulation, and breathing techniques.
Participants receive an immersive virtual reality intervention using nature-based environments. The program consists of 10 group sessions that combine mindfulness, cognitive stimulation, and breathing techniques to promote cognitive and emotional well-being.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in cognitive function (verbal fluency and Digit Span tests)
大体时间:Baseline (pre-intervention) and immediately post-intervention (1 week)
Cognitive function is assessed using verbal fluency tasks and Digit Span tests (forward and backward). Verbal fluency evaluates language and executive function by measuring the number of words generated under specific conditions. Digit Span forward assesses attention, while Digit Span backward assesses working memory. Higher scores indicate better cognitive performance.
Baseline (pre-intervention) and immediately post-intervention (1 week)

次要结果测量

结果测量
措施说明
大体时间
Change in anxiety symptoms (Generalized Anxiety Disorder 7-item scale [GAD-7])
大体时间:Baseline (pre-intervention) and immediately post-intervention (1 week)
Anxiety symptoms are assessed using the GAD-7 questionnaire, a validated self-report scale measuring severity of generalized anxiety symptoms. Higher scores indicate greater anxiety.
Baseline (pre-intervention) and immediately post-intervention (1 week)
Short-form Yesavage Geriatric Depression Scale (GDS-SF)
大体时间:Baseline (pre-intervention) and immediately post-intervention (1 week)
Depressive symptoms are assessed using the GDS-SF, a validated screening tool for depression in older adults. Higher scores indicate greater depressive symptomatology.
Baseline (pre-intervention) and immediately post-intervention (1 week)
Change in positive and negative affect (Positive and Negative Affect Schedule-10 [PANAS-10])
大体时间:Baseline (pre-intervention) and immediately post-intervention (1 week)
Affective state is assessed using the PANAS-10, which measures positive and negative affect. Higher scores reflect higher levels of the corresponding affect.
Baseline (pre-intervention) and immediately post-intervention (1 week)
Change in loneliness (UCLA Loneliness Scale, UCLA-10)
大体时间:Baseline (pre-intervention) and immediately post-intervention (1 week)
Loneliness is assessed using the UCLA-10 scale, a validated self-report measure of perceived social isolation. Higher scores indicate greater loneliness.
Baseline (pre-intervention) and immediately post-intervention (1 week)
Change in quality of life (EuroQol 5-Dimension 5-Level questionnaire [EQ-5D-5L])
大体时间:Baseline (pre-intervention) and immediately post-intervention (1 week)
Quality of life is assessed using the EuroQol-5D-5L questionnaire, which evaluates health status across five dimensions. Higher index values indicate better perceived health-related quality of life.
Baseline (pre-intervention) and immediately post-intervention (1 week)
Change in functional ability (Bayer Activities of Daily Living Scale [BAYER-ADL])
大体时间:Baseline (pre-intervention) and immediately post-intervention (1 week)
Functional ability is assessed using the Bayer Activities of Daily Living Scale, which measures impairments in instrumental activities of daily living. Higher scores indicate greater functional impairment.
Baseline (pre-intervention) and immediately post-intervention (1 week)

其他结果措施

结果测量
措施说明
大体时间
Perceived immersion during virtual reality sessions (Self-Assessment Manikin, SAM)
大体时间:At the end of virtual reality sessions 4, 7, and 10, during the 1-week intervention period.
Immersion is assessed using the Self-Assessment Manikin (SAM), a non-verbal pictorial tool that captures participants' subjective experience during exposure to immersive virtual environments.
At the end of virtual reality sessions 4, 7, and 10, during the 1-week intervention period.
Participant satisfaction with immersive virtual reality sessions
大体时间:At the end of virtual reality sessions 4, 7, and 10, during the 1-week intervention period.
Satisfaction is assessed using an ad hoc questionnaire evaluating participants' experience, acceptability, and perceived usefulness of the intervention.
At the end of virtual reality sessions 4, 7, and 10, during the 1-week intervention period.
Intervention adherence based on session attendance and completion rates
大体时间:At the end of each intervention day: Day 1 (after session 4), Day 2 (after session 7), and Day 3 (after session 10).
Adherence is measured by attendance rate and completion of the scheduled sessions.
At the end of each intervention day: Day 1 (after session 4), Day 2 (after session 7), and Day 3 (after session 10).

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年3月31日

初级完成 (估计的)

2026年11月1日

研究完成 (估计的)

2026年12月1日

研究注册日期

首次提交

2026年4月29日

首先提交符合 QC 标准的

2026年9月1日

首次发布 (实际的)

2026年9月3日

研究记录更新

最后更新发布 (实际的)

2026年9月3日

上次提交的符合 QC 标准的更新

2026年9月1日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

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研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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