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.

NCT06469554 | Completed

• 1 other identifier: MEP-VR
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Hospital Acquired Condition; Frailty

Keywords

Hospital-associated functional decline; Cognitive stimulation; Physical exercise; Virtual Reality; Multicomponent exercise program

Outcome Measures

Primary Outcomes (2)

• The Short Physical Performance Battery (SPPB)

  The Short Physical Performance Battery (SPPB) is a validated instrument used for detecting frailty and predicting disability, institutionalization, and mortality in older adults. It includes the following three tests: Balance tests: Side-by-side stand Semi-tandem stand Tandem stand Gait speed test: Participants are timed walking 4 meters at their usual pace. Chair stand test: Participants are timed as they rise from a chair and return to a seated position five times without using their arms. The SPPB provides a total score ranging from 0 (worst performance) to 12 (best performance) points by summing the scores from each of the three components. Lower SPPB scores indicate poorer physical function and higher risk of adverse health outcomes. The SPPB is a widely used and reliable measure of physical performance in older adults, making it a suitable primary outcome for assessing the functional changes in this study population of hospitalized older individuals

  Measured at baseline, end of 4-day intervention, and 3 months post-discharge.

• Timed Up and Go (TUG)

  The Timed Up and Go (TUG) test is used to assess dynamic balance and risk of falling in older adults. It measures the time in seconds it takes for an individual to get up from a chair, walk 3 meters, and return to the chair

  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 (5)

• Mini-Mental State Examination (MMSE)

  through study completion, an average of 1 year

• Geriatric Depression Scale (GDS):

  through study completion, an average of 1 year

• State-Trait Anxiety Inventory (STAI)

  through study completion, an average of 1 year

• Self-perceived acceptance, usability, and satisfaction using the System Usability Scale

  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

• EuroQol-5D-5L questionnaire

  through study completion, an average of 1 year

Study Arms (2)

Usual Care Group

NO INTERVENTION

Participants randomly assigned to this group will receive standard hospital care, which may include physical rehabilitation if deemed necessary by the clinical staff.

Intervention group

EXPERIMENTAL

Participants in this group will receive a Multicomponent Exercise Program (MEP) or with virtual reality added

Behavioral: MEP-only group; Behavioral: MEP-VR group

Interventions

MEP-only group BEHAVIORAL

Participants in this group will receive a Multicomponent Exercise Program (MEP) consisting of: Supervised aerobic training on a stationary bike Progressive resistance/strength training using weight machines Balance training exercises The MEP sessions will be 30-40 minutes long and conducted over 4 consecutive days.

Intervention group

MEP-VR group BEHAVIORAL

Participants in this group will receive the same MEP intervention as the MEP-only group. Additionally, they will use an immersive virtual reality (IVR) system during the exercise program

Intervention group

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Severe dementia
• Terminal illness
• Clinical instability

Sponsors & Collaborators

• Fundacion Miguel Servet: lead

Study Sites (1)

Hospital Universitario de Navarra

Pamplona, Navarre, 31008, Spain

Location

Related Publications (1)

• Ferrara MC, Zambom-Ferraresi F, Galbete A, Fernandez-Gonzalez de la Riva M, Izco-Cubero M, Garcia-Baztan A, Capon-Saez A, Dominguez-Mendoza S, Marin-Epelde I, Zambom-Ferraresi F, Martinez-Velilla N. 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. Rev Esp Geriatr Gerontol. 2025 Jul-Aug;60(4):101646. doi: 10.1016/j.regg.2025.101646. Epub 2025 Mar 13.

  PMID: 40086340 DERIVED

MeSH Terms

Conditions

Iatrogenic Disease; Frailty; Motor Activity

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants or their caregivers/legal guardians will be informed of their random inclusion in one of the three groups, but they will not be aware of the specific group to which they have been assigned.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 21, 2024
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Instructions for requesting IPD access will be available starting January 2026 at \[research team contact\]. IPD and supporting information will be available for 5 years, after which requests will no longer be accepted. All requests will be fairly and transparently reviewed to ensure compliance with ethical and data protection standards.
• Access Criteria: Sharing study data upon reasonable request Individual participant data (IPD) collected in this randomized controlled trial will be available for sharing upon reasonable request. This includes basic demographic data as well as results from assessments of functionality, cognition, mood, quality of life, and virtual reality experience. Researchers and qualified investigators will be able to access the IPD and supporting information. Upon request, they will be granted access to: Anonymized individual participant-level data Detailed study protocol Statistical analysis plan Annotated case report forms To access the data, researchers will need to submit a formal request to the research team, outlining the intended use of the data. Requests will be evaluated based on scientific merit, conflicts of interest, and compliance with ethical standards. If approved, researchers will be provided secure access to download the relevant files.

Locations

ES (1)