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Feasibility Study of an Interactive Wall-Based Intervention Program for Nursing Home Residents and Patients in Long-Term Care Facilities: Mur'Aventure (MUR'AVENTURE)

2026年9月7日 更新者：Centre Hospitalier Universitaire de Nice
This prospective, single-arm feasibility study aims to evaluate the feasibility of a 12-week immersive exergame program using an interactive wall in older adults living in nursing homes (EHPAD) or long-term care units (USLD). Exergames are interactive digital games that integrate physical activity into gameplay, requiring users to perform whole-body movements to achieve game objectives while promoting exercise and energy expenditure. Participants will complete two supervised 40-minute sessions per week over 12 weeks. The primary objective is to assess feasibility through acceptability, adherence, and safety. Secondary objectives include evaluating implementation fidelity, preliminary effects on cognition, quality of life and well-being, and characterizing the physical and cognitive demands of the interactive games. Data will include usability and enjoyment questionnaires, attendance, adverse events, heart rate monitoring, cognitive performance (MoCA), quality of life (EQ-5D-5L), psychological well-being (Mini-GDS and QUALIDEM), and game performance. The results will inform the design of a future larger-scale effectiveness trial of immersive exergaming in institutionalized older adults.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

25

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

研究联系人备份

学习地点

  • 法国
      • Nice、法国
        • Chu De Nice
        • 接触：
        • 首席研究员：
          • Assia Bebiche Lamali, MD

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

不

描述

Inclusion Criteria:

  • Adults aged 65 years or older.
  • Resident of a nursing home (EHPAD) or long-term care unit (USLD).
  • Affiliated with the French national health insurance system.
  • Able to participate in low-to-moderate intensity adapted physical activity.
  • No cognitive impairment or mild-to-moderate cognitive impairment compatible with understanding simple instructions (MoCA >18 and physician approval).
  • Written informed consent provided by the participant or legal representative.

Exclusion Criteria:

  • Medical contraindication to adapted physical activity.
  • Severe neurological or psychiatric disorder incompatible with safe participation.
  • Severe uncorrected visual, auditory or sensory impairment preventing interaction with the immersive wall.
  • Inability to understand instructions despite adaptation.
  • Participation in another interventional study that may interfere with study outcomes.

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：支持治疗
  • 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 Interactive Wall Exergame Program (Mur'Aventure)
行为的：Immersive Interactive Wall Exergame Program
Participants will complete a supervised 12-week adapted physical activity program delivered through an immersive interactive wall (NeoXperience). Sessions will be performed twice weekly in groups of four participants and will last approximately 40 minutes, including a warm-up. Games are adapted to participants' physical and cognitive abilities and combine cognitive stimulation with whole-body movements. Heart rate, physical activity intensity, game performance, perceived exertion, fatigue and enjoyment will be monitored throughout the intervention.

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
Acceptability of the Mur'Aventure program assessed using the French System Usability Scale (F-SUS)
大体时间：During the 12-week intervention and immediately after the intervention.

Acceptability will be assessed using the French version of the System Usability Scale (F-SUS), a validated 10-item questionnaire evaluating the perceived usability of a system. Total scores range from 0 to 100, with higher scores indicating greater usability and acceptability. Acceptability will be considered achieved if at least 70% of participants obtain a score >70.

Feasibility will be considered successful if all three predefined feasibility criteria (acceptability, adherence, and safety) are met. If one or more criteria are not met, the feasibility of the intervention will be interpreted in light of the unmet criterion(ia), and potential modifications to the intervention or study procedures will be discussed.
During the 12-week intervention and immediately after the intervention.

次要结果测量

结果测量
措施说明
大体时间
Program adherence : predefined feasibility criteria
大体时间：Throughout the 12-week intervention.
Adherence will be evaluated by the completion rate, defined as the proportion of participants completing the entire 12-week intervention. Adherence will be considered good if the completion rate is ≥70%. Attendance rate and dropout rate will also be reported descriptively.
Throughout the 12-week intervention.
Safety of the Mur'Aventure program : predefined feasibility criteria
大体时间：Throughout the 12-week intervention
Safety will be assessed by recording the occurrence of serious adverse events (SAEs) throughout the intervention. Safety will be considered acceptable if no serious adverse events related to the intervention occur. Additional descriptive safety measures include perceived fatigue, perceived exertion, and heart rate responses recorded during each intervention session.
Throughout the 12-week intervention
Intervention fidelity
大体时间：Throughout the 12-week intervention
To describe the fidelity of program implementation, assessed by the proportion of intervention sessions delivered according to the planned protocol Intervention fidelity will be assessed as the percentage of planned exercise sessions completed according to the study protocol. Higher percentages indicate greater fidelity to the intervention.
Throughout the 12-week intervention
Change in Montreal Cognitive Assessment (MoCA) total score
大体时间：Baseline and immediately after the 12-week intervention
To explore the preliminary effects of the program on cognitive function, assessed by the change in the Montreal Cognitive Assessment (MoCA) total score Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), a validated 30-point cognitive screening instrument evaluating memory, executive function, attention, language, visuospatial abilities, abstraction, and orientation. Scores range from 0 to 30, with higher scores indicating better cognitive function. The outcome is the change in total score between baseline and the end of the intervention.
Baseline and immediately after the 12-week intervention
Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) score
大体时间：Baseline and immediately after the 12-week intervention

To explore the preliminary effects of the program on health-related quality of life, assessed by the change in the EuroQol 5-Dimension 5-Level (EQ-5D-5L) score from baseline to post-intervention.

Health-related quality of life will be assessed using the EQ-5D-5L questionnaire, which evaluates mobility, self-care, usual activities, pain/discomfort, and anxiety/depression across five severity levels. Responses are converted into an EQ-5D index value, with higher index values indicating better health-related quality of life. The change in EQ-5D index score between baseline and the end of the intervention will be analyzed
Baseline and immediately after the 12-week intervention
Change in Mini-Geriatric Depression Scale (Mini-GDS) score
大体时间：Baseline and immediately after the 12-week intervention.

To explore the preliminary effects of the program on self-reported psychological well-being, assessed by the change in the 4-item Mini-Geriatric Depression Scale (Mini-GDS) score from baseline to post-intervention.

Psychological well-being will be assessed using the 4-item Mini-Geriatric Depression Scale (Mini-GDS). Scores range from 0 to 4, with higher scores indicating more depressive symptoms and poorer psychological well-being. The outcome is the change in total score between baseline and the end of the intervention
Baseline and immediately after the 12-week intervention.
Change in QUALIDEM total score
大体时间：Baseline and immediately after the 12-week intervention.

To explore the preliminary effects of the program on caregiver-observed well-being, assessed by the change in the French version of the QUALIDEM total score from baseline to post-intervention.

Observed well-being will be assessed using the French version of the QUALIDEM questionnaire, a proxy-rated instrument evaluating quality of life in older adults with cognitive impairment.

Higher score indicating better quality of life. The outcome is the change in total score between baseline and the end of the intervention.
Baseline and immediately after the 12-week intervention.
Mean heart rate during intervention sessions
大体时间：During each intervention session throughout the 12-week intervention.
To describe the physical stimulation induced by the intervention sessions, assessed using heart rate and measured during each session with the Polar Unite wearable device Heart rate will be continuously recorded during each exercise session using a Polar Unite heart rate monitor. Mean heart rate (beats per minute) as well as maximal heart rate will be calculated for each participant during each session. Higher values indicate greater cardiovascular response to exercise.
During each intervention session throughout the 12-week intervention.
Cognitive stimulation during the intervention
大体时间：During each intervention session throughout the 12-week intervention
To describe cognitive stimulation during the intervention, assessed using the game score, number of errors, and completion time automatically recorded during each session Cognitive stimulation will be assessed using the total score, number of errors and completion time automatically recorded by the Mur'Aventure interactive wall software during each exercise session. Higher scores indicate better cognitive stimulation.
During each intervention session throughout the 12-week intervention
Mean physical load during intervention sessions
大体时间：During each intervention session throughout the 12-week intervention.
To describe the physical stimulation induced by the intervention sessions, assessed using heart rate and physical load measured during each session with the Polar Unite wearable device Physical load will be estimated using the Polar Unite wearable device. The device provides a proprietary estimate of exercise load based on heart rate and movement data recorded during each session. Higher values indicate greater physical exercise load.
During each intervention session throughout the 12-week intervention.
Game engagement during the intervention
大体时间：During each intervention session throughout the 12-week intervention
To describe game engagement during the intervention, assessed using the game score, number of errors, and completion time automatically recorded during each session Game engagement will be assessed using the total score, number of errors and completion time automatically recorded by the Mur'Aventure interactive wall software during each exercise session. Higher scores indicate better game performance.
During each intervention session throughout the 12-week intervention

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。

赞助

Centre Hospitalier Universitaire de Nice

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 (估计的)

2026年10月1日

初级完成 (估计的)

2028年1月1日

研究完成 (估计的)

2028年9月1日

研究注册日期

首次提交

2026年7月23日

首先提交符合 QC 标准的

2026年9月7日

首次发布 (实际的)

2026年9月9日

研究记录更新

最后更新发布 (实际的)

2026年9月9日

上次提交的符合 QC 标准的更新

2026年9月7日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • [25-AOIP-06

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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