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.
NCT Number: NCT06469554
Acronym: MEP-VR
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hospital Acquired Condition|Frailty
Interventions: BEHAVIORAL: MEP-only group|BEHAVIORAL: MEP-VR group
Sponsor: Fundacion Miguel Servet
Sex: ALL
Age: OLDER_ADULT
Enrollment: 255
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-01-01
Completion Date: 2025-06-01
Locations: Hospital Universitario de Navarra, Pamplona, Navarra, 31008, Spain

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.

Primary Outcome Measures: 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 Outcome Measures: Mini-Mental State Examination (MMSE), Cognitive evaluation, through study completion, an average of 1 year|Geriatric Depression Scale (GDS):, Specifically designed to assess depression in older adults 15-item questionnaire with a scale ranging from 0 (best) to 15 (worst), through study completion, an average of 1 year|State-Trait Anxiety Inventory (STAI), Assesses both state anxiety (current, transient feelings) and trait anxiety (general, long-term tendency) Contains separate scales for state anxiety and trait anxiety Measures overall anxiety levels, not specifically depression, through study completion, an average of 1 year|Self-perceived acceptance, usability, and satisfaction using the System Usability Scale, The SUS is a 10-question survey that measures a user's subjective assessment of a system's usability on a scale from 1 (lower) to 5 (higher). This validated scale will be used to assess the participants' perceptions of the acceptability, usability, and satisfaction with the VR components integrated into the MEP-VR intervention., 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, It consists of two main components: Descriptive system: Assesses five dimensions of health status: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-point scale from 1 (no problems) to 5 (extreme problems). Visual Analogue Scale (VAS): Allows the participant to rate their overall health on a vertical scale from 0 (worst health state imaginable) to 100 (best health state imaginable). The EQ-5D-5L provides a profile of the respondent's health status across the five dimensions, as well as a single index value for their overall health-related quality of life. Timing: In this study, the EQ-5D-5L will be administered at three time points: 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 outpatient follow-up visit, through study completion, an average of 1 year