Clinical trial NCT06469554: Effect of a Multicomponent Exercise Program With Virtual Reality (MEP-VR) vs Standard Approaches on Functional and Cognitive Domains in Hospitalized Geriatric Patients: Study Protocol for a Randomized Controlled Trial.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hospital Acquired Condition
Frailty
Keywords: Hospital-associated functional decline
Cognitive stimulation
Physical exercise
Virtual Reality
Multicomponent exercise program
Lead sponsor: Fundacion Miguel Servet
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 156
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Severe dementia
* Terminal illness
* Clinical instability

Primary outcomes:
measure: The Short Physical Performance Battery (SPPB)
timeFrame: Measured at baseline, end of 4-day intervention, and 3 months post-discharge.
measure: Timed Up and Go (TUG)
timeFrame: 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
Secondary outcomes:
measure: Mini-Mental State Examination (MMSE)
timeFrame: through study completion, an average of 1 year
measure: Geriatric Depression Scale (GDS):
timeFrame: through study completion, an average of 1 year
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: through study completion, an average of 1 year
measure: Self-perceived acceptance, usability, and satisfaction using the System Usability Scale
timeFrame: 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
measure: EuroQol-5D-5L questionnaire
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra
state: Navarra
Study officials:
References: