Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06340282
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-03-25
Brief Title:
Immersive Virtual Reality and Physical Exercise on Cognitive and Functional Performance in Hospitalized Older Patients
Sponsor:
Fundacion Miguel Servet
Organization:
Fundacion Miguel Servet
Study Overview
Official Title:
Effects of Immersive Virtual Reality andor Multicomponent Physical Exercise on Cognitive and Functional Performance in Hospitalized Older Patients With Severe Functional Dependency Study Protocol for a Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
MOTOMED
Brief Summary:
This study will be conducted in a hospital in Spain to investigate how a special intervention using immersive virtual reality technology can benefit hospitalized older adults with difficulties in their daily functionality
The main objective of this study is to evaluate whether a cognitive stimulation intervention through immersive virtual reality along with specific physical exercises can improve the cognitive and physical function of hospitalized older patients It is expected that this innovative intervention will have a positive impact on the quality of life of these patients
Participants eligible for the study must be over 75 years old have severe functional dependency upon hospital admission and be willing to participate Those with severe dementia or other terminal illnesses will be excluded
Participants will be randomly assigned to one of four study groups a control group without intervention and three intervention groups including viewing Spanish landscapes through virtual reality performing specific physical exercises or a combination of both interventions
At the end of the study various aspects such as cognitive and physical function mood quality of life muscle strength and acceptance of virtual reality technology by patients will be evaluated
This study aims to provide new insights into the care of hospitalized older adults and explore innovative ways to improve their well-being during their hospital stay
The main objective of this study is to evaluate whether a cognitive stimulation intervention through immersive virtual reality along with specific physical exercises can improve the cognitive and physical function of hospitalized older patients It is expected that this innovative intervention will have a positive impact on the quality of life of these patients
Participants eligible for the study must be over 75 years old have severe functional dependency upon hospital admission and be willing to participate Those with severe dementia or other terminal illnesses will be excluded
Participants will be randomly assigned to one of four study groups a control group without intervention and three intervention groups including viewing Spanish landscapes through virtual reality performing specific physical exercises or a combination of both interventions
At the end of the study various aspects such as cognitive and physical function mood quality of life muscle strength and acceptance of virtual reality technology by patients will be evaluated
This study aims to provide new insights into the care of hospitalized older adults and explore innovative ways to improve their well-being during their hospital stay
Detailed Description:
This study will be conducted in a Spanish tertiary hospital to investigate the impact of a cognitive stimulation intervention through immersive virtual reality IVR on hospitalized older adults with severe functional dependency The study will also examine the combined effect of a multicomponent exercise intervention ME with IVR A total of 212 acute patients will be enrolled in the Acute Geriatric Unit of the hospital meeting specific inclusion criteria related to age stability in cardiopulmonary respiratory and neurological systems expected length of stay and ability to communicate and collaborate with the research team Patients will be randomly assigned to a control group or one of three intervention groups IVR ME or IVR ME
The interventions for the IVR and ME groups will involve watching 3D videos of Spanish landscapes and undergoing progressive upper and lower extremity exercises respectively The IVR ME group will receive both interventions while the control group will receive usual care Primary outcome measures include cognitive tests strength assessments and balance and mobility evaluations Secondary outcome measures include mood quality of life functional performance delirium assessments and length of hospital stay
The study will take place in the Acute Geriatric Unit AGU of a tertiary hospital in Pamplona Navarra Spain and will adhere to standard clinical trial guidelines Eligibility criteria include medical inpatients admitted to the AGU between January 2024 and March 2025 with specific inclusion and exclusion criteria The study aims to evaluate the impact of the interventions on cognitive and physical function among hospitalized older adults with severe functional dependency with the goal of enhancing their well-being and care during hospitalization
The research team anticipates that the interventions will positively influence cognitive function physical performance mood quality of life isometric strength and acceptance of virtual reality technology among participants The studys comprehensive approach encompasses various assessments to provide a holistic evaluation of the interventions effectiveness in improving outcomes for hospitalized older adults with severe functional dependency
Overall this study represents a significant effort to understand how innovative interventions such as cognitive stimulation through IVR and multicomponent physical exercise could positively impact the health outcomes and quality of life of hospitalized older adults with severe functional dependency The studys findings are expected to provide valuable insights for healthcare providers researchers and policymakers seeking to optimize care for this population
The interventions for the IVR and ME groups will involve watching 3D videos of Spanish landscapes and undergoing progressive upper and lower extremity exercises respectively The IVR ME group will receive both interventions while the control group will receive usual care Primary outcome measures include cognitive tests strength assessments and balance and mobility evaluations Secondary outcome measures include mood quality of life functional performance delirium assessments and length of hospital stay
The study will take place in the Acute Geriatric Unit AGU of a tertiary hospital in Pamplona Navarra Spain and will adhere to standard clinical trial guidelines Eligibility criteria include medical inpatients admitted to the AGU between January 2024 and March 2025 with specific inclusion and exclusion criteria The study aims to evaluate the impact of the interventions on cognitive and physical function among hospitalized older adults with severe functional dependency with the goal of enhancing their well-being and care during hospitalization
The research team anticipates that the interventions will positively influence cognitive function physical performance mood quality of life isometric strength and acceptance of virtual reality technology among participants The studys comprehensive approach encompasses various assessments to provide a holistic evaluation of the interventions effectiveness in improving outcomes for hospitalized older adults with severe functional dependency
Overall this study represents a significant effort to understand how innovative interventions such as cognitive stimulation through IVR and multicomponent physical exercise could positively impact the health outcomes and quality of life of hospitalized older adults with severe functional dependency The studys findings are expected to provide valuable insights for healthcare providers researchers and policymakers seeking to optimize care for this population
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