Immersive Virtual Reality and Physical Exercise on Cognitive and Functional Performance in Hospitalized Older Patients (MOTOMED)

Effects of Immersive Virtual Reality and/or Multicomponent Physical Exercise on Cognitive and Functional Performance in Hospitalized Older Patients With Severe Functional Dependency: Study Protocol for a Randomized Clinical Trial

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

Study Overview

• Status: Recruiting
• Conditions: Cognition; Disability Physical
• Intervention / Treatment: Device: Virtual reality; Behavioral: multicomponent exercise

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 study's 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 study's findings are expected to provide valuable insights for healthcare providers, researchers, and policymakers seeking to optimize care for this population.

• Study Type: Interventional
• Enrollment (Estimated): 212
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicolas Martinez-Velilla Dr, PhD; Phone Number: 00 34 848422222; Email: nicolas.martinez.velilla@navarra.es
• Study Contact Backup: Name: Fabricio Zambom Dr, PhD; Phone Number: 00 34 848422222; Email: fabricio.zambom.ferraresi@navarra.es

Study Locations

• Spain
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Recruiting
      • Hospital Universitario de Navarra
      • Contact: NICOLAS MARTINEZ-VELILLA, PHD; Phone Number: 0034670900434; Email: nicolas.martinez.velilla@navarra.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Age ≥ 75 years Clinica Stability Expected length of stay ≥ 5 days Being able to communicate and collaborate with the research team

Exclusion Criteria:

Barthel Index score ≥ 60 at admission Refusal to sign the informed consent by the patient/legal guardian or inability to obtain it Life expectancy less than three months End-stage disease Severe level of major neurocognitive disorder (GDS 7)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Control group
Experimental: immersive virtual reality; Patients use virtual reality	Device: Virtual reality; Immersive virtual reality
Experimental: multicomponent physical exercise intervention; Individualized exercise intervention	Behavioral: multicomponent exercise; individualized exercise
Experimental: Immersive virtual reality and multicomponent physical exercise intervention; Both	Device: Virtual reality; Immersive virtual reality; Behavioral: multicomponent exercise; individualized exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mini-Mental State Examination (MMSE)	Cognitive evolution	Baseline, day 3, at discharge and 1 month after discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Isometric handgrip strength	Muscle strength measurement	Baseline, day 3, at discharge and 1 month after discharge

Collaborators and Investigators

• Sponsor: Fundacion Miguel Servet
• Investigators: Principal Investigator: Nicolas Martinez-Velilla Dr, PhD, Fundación Miguel Servet - Navarrabiomed

Publications and helpful links

General Publications

• Cuevas-Lara C, Saez de Asteasu ML, Ramirez-Velez R, Izquierdo M, Zambom-Ferraresi F, Antonanzas-Valencia C, Galbete A, Zambom-Ferraresi F, Martinez-Velilla N. Effects of game-based interventions on functional capacity in acutely hospitalised older adults: results of an open-label non-randomised clinical trial. Age Ageing. 2022 Jan 6;51(1):afab247. doi: 10.1093/ageing/afab247.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: March 25, 2024
• First Submitted That Met QC Criteria: March 29, 2024
• First Posted (Actual): April 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 10, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: disability; immersive virtual reality; cognitive stimulation; hospital-associated functional decline; multicomponent physical exercise
• Other Study ID Numbers: MOTOMED

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The plan to share anonymized data from a randomized clinical trial in response to reasonable requests focuses on ensuring confidentiality and protecting the privacy of participants. This plan includes fully anonymizing the data, creating a detailed data sharing protocol, establishing an independent data review committee, implementing a clear request procedure, requiring confidentiality agreements to be signed by requestors, and applying robust security measures to protect data integrity. The primary goal is to facilitate access to data to promote transparency and scientific advancement while ensuring respect for the privacy and confidentiality of clinical trial participants. It is important to note that data will be shared under reasonable requests.
• IPD Sharing Time Frame: After the paper is published
• IPD Sharing Access Criteria: Any reasonable demand
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No