Population aging is associated with an increased risk of frailty, falls, and loss of autonomy. This pilot study aims to evaluate the effects of a program that combines multicomponent exercise and non-immersive virtual reality (MCE+VR-NI), compared with virtual reality alone (VR-NI) and usual treatment. The primary objective is to determine the program's impact on physical function, balance, cognition, and occupational participation in community-dwelling adults aged over 65 years.
This is a mixed-methods pilot study consisting of a two-arm randomized controlled trial and a non-randomized parallel cohort for the control group. Participants will be allocated in a 1:1:1 ratio to the intervention or control groups. The intervention period will last 8 weeks. Quantitative outcomes (SPPB, FRAIL Scale, TUG, MoCA, COPM, WHODAS 2.0) will be assessed at baseline and post-intervention. In addition, qualitative interviews will be conducted to explore participants' subjective experiences and motivation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Participants will undergo an 8-week multicomponent exercise program combined with non-immersive virtual reality (VR). Sessions will be conducted twice weekly (60 minutes each) and will include strength, balance, coordination, and functional mobility training, along with VR-based motor and cognitive stimulation using a non-immersive system. The intervention will be delivered in a supervised group setting.
Participants will receive non-immersive virtual reality training for 8 weeks, with two supervised sessions per week (60 minutes each), focused on motor and cognitive stimulation.
INNOVEAS Innovation Center, Spanish Red Cross (Valladolid), Spain
Valladolid, Valladolid, Spain
Change in physical function (SPPB score)
Physical function will be assessed using the Short Physical Performance Battery (SPPB), which includes balance, gait speed, and chair stand tests, with a total score ranging from 0 to 12. Higher scores indicate better physical function.
Time frame: Baseline and 8 weeks
Change in mobility (Timed Up and Go test)
Mobility will be assessed using the Timed Up and Go (TUG) test. The time in seconds required to stand up from a chair, walk three meters, turn, walk back, and sit down will be recorded, with no fixed minimum or maximum score. Lower times indicate better mobility and lower fall risk.
Time frame: Baseline and 8 weeks
Change in handgrip strength
Handgrip strength will be measured in kilograms using a Jamar dynamometer, with no fixed minimum or maximum score. Higher values indicate greater muscular strength.
Time frame: Baseline and 8 weeks
Change in cognitive function (MoCA score)
Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), a screening tool that evaluates multiple cognitive domains including memory, attention, language, executive function, and visuospatial abilities, with a score ranging from 0 to 30. Higher scores indicate better cognitive function.
Time frame: Baseline and 8 weeks
Change in frailty status (FRAIL Scale)
Frailty will be assessed using the FRAIL Scale, which includes five domains: fatigue, resistance, ambulation, illnesses, and weight loss, with a score ranging from 0 to 5. Higher scores indicate greater frailty.
Time frame: Baseline and 8 weeks
Change in occupational performance and satisfaction (COPM)
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Occupational performance and satisfaction will be assessed using the Canadian Occupational Performance Measure (COPM), which evaluates self-perceived performance and satisfaction in meaningful daily activities. Participants identify up to five priority activities in daily living, which are then rated for performance and satisfaction on scales ranging from 1 (not able to do it / not satisfied at all) to 10 (able to do it extremely well / extremely satisfied). Higher scores indicate better perceived performance and satisfaction. Changes in occupational performance will be assessed based on COPM scores.
Time frame: Baseline and 8 weeks
Change in disability and participation (WHODAS 2.0)
Disability and participation will be assessed using the WHODAS 2.0 (36-item version), which evaluates functioning across multiple domains, with a standardized score ranging from 0 to 100. Higher scores indicate greater disability.
Time frame: Baseline and 8 weeks