Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06469554 |
| Other study ID # |
MEP-VR |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2024 |
| Est. completion date |
June 1, 2025 |
Study information
| Verified date |
June 2024 |
| Source |
Fundacion Miguel Servet |
| Contact |
Nicolas Martínez-Velilla, PhD |
| Phone |
Spain +34 848-422222 |
| Email |
nicolas.martinez.velilla[@]navarra.es |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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
