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

NCT06340282 | Recruiting

• 1 other identifier: MOTOMED
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

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

Conditions

Disability Physical; Cognition

Keywords

hospital-associated functional decline; cognitive stimulation; immersive virtual reality; multicomponent physical exercise; disability

Outcome Measures

Primary Outcomes (1)

• Mini-Mental State Examination (MMSE)

  Cognitive evolution

  Baseline, day 3, at discharge and 1 month after discharge

Secondary Outcomes (1)

• Isometric handgrip strength

  Baseline, day 3, at discharge and 1 month after discharge

Study Arms (4)

Control

NO INTERVENTION

Control group

immersive virtual reality

EXPERIMENTAL

Patients use virtual reality

Device: Virtual reality

multicomponent physical exercise intervention

EXPERIMENTAL

Individualized exercise intervention

Behavioral: multicomponent exercise

Immersive virtual reality and multicomponent physical exercise intervention

EXPERIMENTAL

Both

Device: Virtual reality; Behavioral: multicomponent exercise

Interventions

Virtual reality DEVICE

Immersive virtual reality

Immersive virtual reality and multicomponent physical exercise intervention; immersive virtual reality

multicomponent exercise BEHAVIORAL

individualized exercise

Immersive virtual reality and multicomponent physical exercise intervention; multicomponent physical exercise intervention

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fundacion Miguel Servet: lead

Study Sites (1)

Hospital Universitario de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Related Publications (2)

• 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.

  PMID: 35077558 RESULT

• de la Casa-Marin A, Zambom-Ferraresi F, Ferrara MC, Ollo-Martinez I, Galbete A, Gonzalez-Glaria B, Moral-Cuesta D, Marin-Epelde I, Chenhuichen C, Lorente-Escudero M, Molero-de-Avila R, Baztan AG, Zambom-Ferraresi F, Martinez-Velilla N. Effects of immersive virtual reality stimulation 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. BMC Geriatr. 2024 Nov 8;24(1):924. doi: 10.1186/s12877-024-05516-x.

  PMID: 39516806 DERIVED

Study Officials

• Nicolas Martinez-Velilla Dr, PhD

  Fundación Miguel Servet - Navarrabiomed

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas Martinez-Velilla Dr, PhD

CONTACT

00 34 848422222; nicolas.martinez.velilla@navarra.es

Fabricio Zambom Dr, PhD

CONTACT

00 34 848422222; fabricio.zambom.ferraresi@navarra.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This clinical randomized controlled trial will be conducted in the Acute Geriatric Unit of a tertiary hospital in Spain. A total of 212 acute patients will be enrolled according to the following criteria: age \> 75, Barthel Index \< 60, able to collaborate, expected length of stay \> 5 days, absence of clinical instability and severe dementia (GDS 7) or other end-stage disease. Patients will be randomly assigned to a control group (CG) or any of the three intervention groups (IG): IVR, ME, or IVR + ME. The IVR group will watch ad-hoc videos showing Spanish regional landscapes and villages, approximately 4 minutes per day for three consecutive days. The ME group will undergo aerobic and strength exercise for progressive training of the upper and lower limbs. The IVR + ME group will do both cognitive and physical intervention. The primary outcomes will be cognitive and physical measures at discharge. Mood, quality of life, isometric strength, and acceptance of IVR will be also assessed.

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 1, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After the paper is published
• Access Criteria: Any reasonable demand

Locations

ES (1)