Effect of a Multicomponent Exercise Program With Virtual Reality (MEP-VR) Versus Standard Approaches on Functional and Cognitive Domains in Hospitalised Geriatric Patients: Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Timed Up and Go (TUG)
研究概览
简要总结
The goal of this clinical trial is to test the effectiveness of a Multicomponent Exercise Program with Virtual Reality (MEP-VR) compared to a Multicomponent Exercise Program (MEP-only) or usual care, in terms of functional and cognitive outcomes in hospitalized older adults.
The main questions it aims to answer are:
- Does the MEP-VR program improve the functionality of hospitalized older adults compared to the other groups?
- Does the MEP-VR program improve the cognitive, mood, and quality of life outcomes of hospitalized older adults compared to the other groups?
Participants will be randomly assigned to one of three groups: a control group or one of the two intervention groups. The intervention groups will receive either the MEP-VR or MEP-only program, which consists of supervised aerobic exercise, resistance training, and balance training, with or without a virtual reality component designed specifically for this study. The intervention will take place over four consecutive days, with each session lasting 30-40 minutes.
The primary outcome will be the functional changes at the time of discharge. Cognition, mood, quality of life, and VR usability will also be assessed.
Technological advances are rapidly increasing with population aging, creating potential benefits for integrating technology into the care of older adults. This study comprehensively evaluates the implementation of VR combined with the multicomponent exercise program. If the hypothesis is confirmed, it would pave the way for modifying the hospitalization system and reducing the critical healthcare burden resulting from the commonly acquired disability in the older population.
详细描述
Acute hospitalization often leads to functional impairment and disability in older adults as a side effect. Reduced physiological resources increase the risk of negative consequences like functional and cognitive decline, longer hospital stays, and higher mortality and institutionalization rates. Approximately 30-50% of hospitalized older adults experience functional decline, which increases their risk of worsening function or death in the year after discharge.
Conventional care models tend to overlook the negative effects of hospitalization and fail to leverage the potential benefits of technology. Recent studies have found that physical exercise and early rehabilitation programs can prevent functional and cognitive decline during hospitalization and reduce hospital stay and mortality. While Multicomponent Exercise Programs (MEP) that focus on promoting mobility have shown benefits, adding virtual reality (VR) to MEP (MEP-VR) may provide additional physical and cognitive performance improvements in hospitalized patients.
VR is an emerging tool that can engage older adults in physical and cognitive activities. Immersive VR (IVR) systems like head-mounted displays can transport users into virtual environments to execute activities and stimulate cognitive skills. VR is considered an affordable, novel, and safe tool, but further research is needed on its benefits and limitations for older adults.
The main aim of this study is to investigate the effects of MEP-VR on functional and cognitive outcomes in hospitalized older adults compared to standard care. It will also assess the effects on mood, safety, and usability.
Methods
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Participants or their caregivers/legal guardians will be informed of their random inclusion in one of the three groups, but they will not be aware of the specific group to which they have been assigned.
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 75 years or older
- •Barthel Index score of at least 60 points
- •Able to walk and cooperate
- •Estimated hospital stay of at least 4 days
- •Able to provide informed consent
排除标准
- •Severe dementia
- •Terminal illness
- •Clinical instability
研究组 & 干预措施
Usual Care Group
Participants randomly assigned to this group will receive standard hospital care, which may include physical rehabilitation if deemed necessary by the clinical staff.
Intervention group
Participants in this group will receive a Multicomponent Exercise Program (MEP) or with virtual reality added
干预措施: MEP-only group (Behavioral)
Intervention group
Participants in this group will receive a Multicomponent Exercise Program (MEP) or with virtual reality added
干预措施: MEP-VR group (Behavioral)
结局指标
主要结局
Timed Up and Go (TUG)
时间窗: The TUG will be administered at the same three time points as the other primary outcome measures: At the start of the 4-day intervention during acute hospitalization At the end of the 4-day intervention 3 months after hospital discharge during the outpa
The Timed Up and Go (TUG) test is used to assess dynamic balance and risk of falling in older adults. It measures the time in seconds it takes for an individual to get up from a chair, walk 3 meters, and return to the chair
The Short Physical Performance Battery (SPPB)
时间窗: Measured at baseline, end of 4-day intervention, and 3 months post-discharge.
The Short Physical Performance Battery (SPPB) is a validated instrument used for detecting frailty and predicting disability, institutionalization, and mortality in older adults. It includes the following three tests: Balance tests: Side-by-side stand Semi-tandem stand Tandem stand Gait speed test: Participants are timed walking 4 meters at their usual pace. Chair stand test: Participants are timed as they rise from a chair and return to a seated position five times without using their arms. The SPPB provides a total score ranging from 0 (worst performance) to 12 (best performance) points by summing the scores from each of the three components. Lower SPPB scores indicate poorer physical function and higher risk of adverse health outcomes. The SPPB is a widely used and reliable measure of physical performance in older adults, making it a suitable primary outcome for assessing the functional changes in this study population of hospitalized older individuals
次要结局
- Mini-Mental State Examination (MMSE)(through study completion, an average of 1 year)
- Geriatric Depression Scale (GDS):(through study completion, an average of 1 year)
- State-Trait Anxiety Inventory (STAI)(through study completion, an average of 1 year)
- Self-perceived acceptance, usability, and satisfaction using the System Usability Scale(The SUS will be administered during the 4-day intervention period, while the participants are actively using the VR system as part of the MEP-VR program)
- EuroQol-5D-5L questionnaire(through study completion, an average of 1 year)