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.

Background: Hospital-associated functional decline affects nearly one-third of the hospitalized older adults. The aim of this trial is to investigate the effect of a cognitive stimulation intervention provided via immersive virtual reality (IVR), with or without a multicomponent physical exercise intervention (ME) in hospitalized patients aged 75 or older with severe functional dependency at admission (Barthel Index < 60 points).

Methods: 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 (Global Deterioration Scale 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 min 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.

Discussion: This project has the potential to enhance physical and psychological well-being of patients with severe functional dependency hospitalized for acute conditions, using technology. Virtual reality is expected to be favourably perceived by hospitalized older adults. This intervention represents a novelty in the geriatric patients' care, comprising IVR and/or ME dispensed within the patient's room, and including patients who are commonly excluded from research clinical trials.

Trial registration: This study was approved by the Navarra Clinical Research Ethics Committee on May 17th, 2023 (PI_2023/60). The trial is registered at ClinicalTrials.gov, registration number NCT06340282, 24th May 2024.