Ignite Creation Date:
2024-07-17 @ 10:57 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06469554
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-12
Brief Title:
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
Sponsor:
Fundacion Miguel Servet
Organization:
Fundacion Miguel Servet
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MEP-VR
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
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 Patientscaregivers 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 ClinicalTrialsgov
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
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 Patientscaregivers 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 ClinicalTrialsgov
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None