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

Brief Summary

Detailed Description

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 This will be a three-arm randomized clinical trial with two experimental intervention groups (MEP-only, MEP-VR) and a control group (usual care). It will be conducted in the Acute Geriatric Unit (AGU) at a hospital in Spain. Eligible patients aged 75+ with a Barthel Index score of at least 60, who can walk and cooperate, have an estimated hospital stay of at least 4 days, and provide informed consent, will be randomly assigned to one of the three groups. Those with severe dementia, terminal illness, or clinical instability will be excluded. The MEP-only group will receive supervised aerobic, resistance, and balance training over 4 consecutive days. The MEP-VR group will receive the same MEP with the addition of IVR components, including using VR during the bike warm-up and while doing resistance exercises. The control group will receive usual care. Outcomes will be assessed at baseline, end of intervention, and 3 months post-discharge. The primary outcome is functional changes at discharge, measured by the Short Physical Performance Battery, Timed Up and Go, Barthel Index, handgrip strength, and 1-repetition maximum strength tests. Secondary outcomes include cognition, mood, quality of life, and VR-related measures like usability and cybersickness. The study will be conducted according to randomization and blinding principles. The researcher assigning groups will be different from the attending geriatrician. Patients/caregivers will be blinded to group allocation. Assessors will be blinded but intervention staff will not. Adverse events and dropouts will be recorded. The study was approved by the ethics committee and registered at ClinicalTrials.gov. Intervention Details The MEP-only intervention will consist of: 7-10 min warm-up on a stationary bike 15-20 min resistance training using weight machines 10 min balance training using light-based exercises The MEP-VR intervention will include the same MEP components plus: VR during the bike warm-up, allowing patients to virtually tour different locations VR during resistance exercises, with a virtual rural environment displayed The VR system was developed using Unity, C++, OpenXR, and Low Poly graphics for optimal performance and visual comfort The usual care control group will receive standard hospital care, including physical rehabilitation if needed. Outcomes Primary outcome: Changes in functional capabilities during the study period, assessed through: Short Physical Performance Battery Timed Up and Go test Barthel Index Handgrip strength 1-repetition maximum strength tests Secondary outcomes: Changes in cognitive function (Mini-Mental State Exam) Changes in mood (Geriatric Depression Scale, Anxiety Inventory) Quality of life (EuroQol-5D-5L) VR-related outcomes (usability, cybersickness, satisfaction) Adverse events, adherence, and perceived exertion Discussion This study focuses on developing individualized, multicomponent programs to address and prevent functional decline in hospitalized older adults by incorporating innovative technologies like VR. Advances in technology are increasing concurrently with population aging, presenting opportunities to integrate technology into elder care. However, older adults are often excluded from research, leading to limited knowledge on the potential benefits of these technologies. This randomized trial comprehensively evaluates the implementation of IVR combined with a multicomponent exercise program. It assesses whether IVR can provide greater motivation and willingness to exercise, leading to greater functional and cognitive improvements, as well as impacts on mood, quality of life, and feasibility. If the hypothesis is confirmed, this project could pave the way for modifying the hospitalization system to leverage technology and help reduce the critical healthcare burden resulting from hospital-acquired disability in older adults

Primary Outcomes

Secondary Outcomes

• Mini-Mental State Examination (MMSE)(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)
• Geriatric Depression Scale (GDS):(through study completion, an average of 1 year)